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White Matter Shows Decline After Bipolar Diagnosis
based on data from 88 individuals.
Patients with bipolar disorder demonstrate cognitive impairment and brain structure abnormalities, including global white matter loss, that have been associated with poor outcomes, but data on the stability or progression of neuroanatomical changes are limited, wrote Julian Macoveanu, PhD, of Copenhagen University Hospital, Denmark, and colleagues.
In a study published in The Journal of Affective Disorders, the researchers identified 97 adults aged 18 to 60 years with recently diagnosed bipolar disorder and matched them with 66 healthy controls. Participants were enrolled in the larger Bipolar Illness Onset (BIO) study. All participants underwent structural MRI and neuropsychological testing at baseline and were in full or partial remission based on total scores of 14 or less on the Hamilton Depression Rating Scale and the Young Mania Rating Scale. Approximately half of the participants (50 bipolar patients and 38 controls) participated in follow-up scans and testing after 6-27 months (mean 16 months), because of limited resources, according to the researchers.
The researchers compared changes in cortical gray matter volume and thickness, total cerebral white matter, hippocampal and amygdala volumes, estimated brain age, and cognitive functioning over time. In addition, they examined within-patient associations between baseline brain structure abnormalities and later mood episodes.
Overall, bipolar patients (BD) showed a significant decrease in total cerebral white matter from baseline, compared with healthy controls (HC) in mixed models (P = .006). “This effect was driven by BD patients showing a decrease in WM volume over time compared to HC who remained stable,” the researchers wrote, and the effect persisted in a post hoc analysis adjusting for subsyndromal symptoms and body mass index.
BD patients also had a larger amygdala volume at baseline and follow-up than HC, but no changes were noted between the groups. Changes in hippocampal volume also remained similar between the groups.
Analysis of cognitive data showed no significant differences in trajectories between BD patients and controls across cognitive domains or globally; although BD patients performed worse than controls at both time points.
BD patients in general experienced lower functioning and worse quality of life, compared with controls, but the trajectories of each group were similar for both functional and quality of life.
The researchers found no significant differences over time in total white matter, hippocampus, or amygdala volumes between BD patients who experienced at least one mood episode during the study period and those who remained in remission.
The findings were limited by several factors including the small sample size and limited generalizability of the findings because of the restriction to patients in full or partial remission, the researchers noted. Other limitations included the variation in follow-up time and the potential impact of psychotropic medication use.
However, the results were strengthened by the use of neuropsychiatric testing in addition to MRI to compare brain structure and cognitive function, the researchers said. The data suggest that both amygdala volume and cognitive impairment may be stable markers of BD soon after diagnosis, but that decreases in white matter may stem from disease progression.
The BIO study is funded by the Mental Health Services, Capital Region of Denmark, the Danish Council for Independent Research, Medical Sciences, Weimans Fund, Markedsmodningsfonden, Gangstedfonden, Læge Sofus Carl Emil og hustru Olga Boris Friis’ legat, Helsefonden, Innovation Fund Denmark, Copenhagen Center for Health Technology (CACHET), EU H2020 ITN, Augustinusfonden, and The Capital Region of Denmark. Macoveanu had no financial conflicts to disclose.
based on data from 88 individuals.
Patients with bipolar disorder demonstrate cognitive impairment and brain structure abnormalities, including global white matter loss, that have been associated with poor outcomes, but data on the stability or progression of neuroanatomical changes are limited, wrote Julian Macoveanu, PhD, of Copenhagen University Hospital, Denmark, and colleagues.
In a study published in The Journal of Affective Disorders, the researchers identified 97 adults aged 18 to 60 years with recently diagnosed bipolar disorder and matched them with 66 healthy controls. Participants were enrolled in the larger Bipolar Illness Onset (BIO) study. All participants underwent structural MRI and neuropsychological testing at baseline and were in full or partial remission based on total scores of 14 or less on the Hamilton Depression Rating Scale and the Young Mania Rating Scale. Approximately half of the participants (50 bipolar patients and 38 controls) participated in follow-up scans and testing after 6-27 months (mean 16 months), because of limited resources, according to the researchers.
The researchers compared changes in cortical gray matter volume and thickness, total cerebral white matter, hippocampal and amygdala volumes, estimated brain age, and cognitive functioning over time. In addition, they examined within-patient associations between baseline brain structure abnormalities and later mood episodes.
Overall, bipolar patients (BD) showed a significant decrease in total cerebral white matter from baseline, compared with healthy controls (HC) in mixed models (P = .006). “This effect was driven by BD patients showing a decrease in WM volume over time compared to HC who remained stable,” the researchers wrote, and the effect persisted in a post hoc analysis adjusting for subsyndromal symptoms and body mass index.
BD patients also had a larger amygdala volume at baseline and follow-up than HC, but no changes were noted between the groups. Changes in hippocampal volume also remained similar between the groups.
Analysis of cognitive data showed no significant differences in trajectories between BD patients and controls across cognitive domains or globally; although BD patients performed worse than controls at both time points.
BD patients in general experienced lower functioning and worse quality of life, compared with controls, but the trajectories of each group were similar for both functional and quality of life.
The researchers found no significant differences over time in total white matter, hippocampus, or amygdala volumes between BD patients who experienced at least one mood episode during the study period and those who remained in remission.
The findings were limited by several factors including the small sample size and limited generalizability of the findings because of the restriction to patients in full or partial remission, the researchers noted. Other limitations included the variation in follow-up time and the potential impact of psychotropic medication use.
However, the results were strengthened by the use of neuropsychiatric testing in addition to MRI to compare brain structure and cognitive function, the researchers said. The data suggest that both amygdala volume and cognitive impairment may be stable markers of BD soon after diagnosis, but that decreases in white matter may stem from disease progression.
The BIO study is funded by the Mental Health Services, Capital Region of Denmark, the Danish Council for Independent Research, Medical Sciences, Weimans Fund, Markedsmodningsfonden, Gangstedfonden, Læge Sofus Carl Emil og hustru Olga Boris Friis’ legat, Helsefonden, Innovation Fund Denmark, Copenhagen Center for Health Technology (CACHET), EU H2020 ITN, Augustinusfonden, and The Capital Region of Denmark. Macoveanu had no financial conflicts to disclose.
based on data from 88 individuals.
Patients with bipolar disorder demonstrate cognitive impairment and brain structure abnormalities, including global white matter loss, that have been associated with poor outcomes, but data on the stability or progression of neuroanatomical changes are limited, wrote Julian Macoveanu, PhD, of Copenhagen University Hospital, Denmark, and colleagues.
In a study published in The Journal of Affective Disorders, the researchers identified 97 adults aged 18 to 60 years with recently diagnosed bipolar disorder and matched them with 66 healthy controls. Participants were enrolled in the larger Bipolar Illness Onset (BIO) study. All participants underwent structural MRI and neuropsychological testing at baseline and were in full or partial remission based on total scores of 14 or less on the Hamilton Depression Rating Scale and the Young Mania Rating Scale. Approximately half of the participants (50 bipolar patients and 38 controls) participated in follow-up scans and testing after 6-27 months (mean 16 months), because of limited resources, according to the researchers.
The researchers compared changes in cortical gray matter volume and thickness, total cerebral white matter, hippocampal and amygdala volumes, estimated brain age, and cognitive functioning over time. In addition, they examined within-patient associations between baseline brain structure abnormalities and later mood episodes.
Overall, bipolar patients (BD) showed a significant decrease in total cerebral white matter from baseline, compared with healthy controls (HC) in mixed models (P = .006). “This effect was driven by BD patients showing a decrease in WM volume over time compared to HC who remained stable,” the researchers wrote, and the effect persisted in a post hoc analysis adjusting for subsyndromal symptoms and body mass index.
BD patients also had a larger amygdala volume at baseline and follow-up than HC, but no changes were noted between the groups. Changes in hippocampal volume also remained similar between the groups.
Analysis of cognitive data showed no significant differences in trajectories between BD patients and controls across cognitive domains or globally; although BD patients performed worse than controls at both time points.
BD patients in general experienced lower functioning and worse quality of life, compared with controls, but the trajectories of each group were similar for both functional and quality of life.
The researchers found no significant differences over time in total white matter, hippocampus, or amygdala volumes between BD patients who experienced at least one mood episode during the study period and those who remained in remission.
The findings were limited by several factors including the small sample size and limited generalizability of the findings because of the restriction to patients in full or partial remission, the researchers noted. Other limitations included the variation in follow-up time and the potential impact of psychotropic medication use.
However, the results were strengthened by the use of neuropsychiatric testing in addition to MRI to compare brain structure and cognitive function, the researchers said. The data suggest that both amygdala volume and cognitive impairment may be stable markers of BD soon after diagnosis, but that decreases in white matter may stem from disease progression.
The BIO study is funded by the Mental Health Services, Capital Region of Denmark, the Danish Council for Independent Research, Medical Sciences, Weimans Fund, Markedsmodningsfonden, Gangstedfonden, Læge Sofus Carl Emil og hustru Olga Boris Friis’ legat, Helsefonden, Innovation Fund Denmark, Copenhagen Center for Health Technology (CACHET), EU H2020 ITN, Augustinusfonden, and The Capital Region of Denmark. Macoveanu had no financial conflicts to disclose.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
DIY Brain Stimulation Is Growing in Popularity, but Is It Safe, Effective?
As at-home, do-it-yourself (DIY) brain stimulation devices like transcranial direct current stimulation (tDCS) gain popularity for common psychiatric conditions like depression, anxiety, and posttraumatic stress disorder (PTSD), questions arise about their safety and efficacy.
However, the US Food and Drug Administration (FDA) has yet to “fully” clear any of these devices and has only granted breakthrough device designation to a few. In addition, most of the portable products don’t market themselves as medical interventions, putting them into a regulatory “gray area” that has little oversight.
This has led to a free-for-all environment, allowing individuals to purchase these products online and self-administer “treatment” — often without the guidance or even knowledge of their healthcare providers.
So how effective and safe are these noninvasive brain stimulators, and what guidance, if any, should clinicians provide to patients who are or are contemplating using them at home; what does the research show, and what are the ethical considerations?
What the Research Shows
Data from studies examining unsupervised at-home and use under medical supervision are mixed. Results from a recent randomized trial of more than 200 participants showed no significant difference in safety or efficacy between adjunctive at-home tDCS and at-home sham tDCS for depressive symptoms.
“To be fair, they did not find any unexpected safety issues. What they did find was that there was no clear signal that it worked,” said Noah S. Philip, MD, professor of psychiatry and human behavior, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
Philip, who is also lead for mental health research at Brown’s Center for Neurorestoration and Neurotechnology, Providence, Rhode Island, and was not involved in the study, noted that while other research papers have shown more promising results for depression and other conditions such as adult attention-deficit/hyperactivity disorder (ADHD) and pain, they often are not placebo controlled or include large numbers of patients.
Still, he added the growing use of these devices reflects the fact that standard treatment often doesn’t meet patients’ needs.
“Broadly speaking, part of the hope with brain stimulation is that instead of taking a pill, we’re trying to more directly affect the brain tissues involved — and therefore, avoid the issue of having systemic side effects that you get from the meds. There’s certainly a hunger” for better interventions, Philip said.
tDCS involves a low-intensity electrical current applied through electrodes on the scalp in order to influence brain activity. Generally speaking, it emits less energy than other types of noninvasive brain stimulation, such as transcranial magnetic stimulation. “The trade-off is that’s it also a little harder to find a clear signal about how it works,” Philip said.
As such, he added, it’s important for clinicians to familiarize themselves with these devices, to ask about patient use, and to set up structured assessments of efficacy and adverse events.
Results from a randomized trial published last year in The Lancet showed no significant benefit for in-office use of tDCS plus a selective serotonin reuptake inhibitor vs sham tDCS for major depression.
On the other hand, a randomized trial published earlier this year in Brain Stimulation showed that older adults who received active tDCS had greater reductions in depressive and anxiety symptoms than those in the sham group.
In addition, results from a small study of eight participants published last year in SAGE Open Medicine showed adjuvant tDCS helped patients with refractory PTSD. Finally, a randomized trial of 54 veterans from Philip’s own team showed tDCS plus virtual reality was effective for combat-related PTSD.
Although there have also been several studies showing possible benefit of tDCS for Alzheimer’s disease, Gayatri Devi, MD, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, noted in a Medscape Neurology Decision Point that “the problem with all these studies is that they’re all very small, and there [are] so many different variables in terms of how you interpret response.”
On-Demand Brain Stim
As for at-home use, there’s now a wide offering of these types of devices available online, allowing an individual to apply daily brain stimulation via headsets, dispensing with the need to consult a clinician. Most are battery-powered and emit a low-level current.
Philip noted that there are essentially two ways to obtain such devices. Some are readily available from online stores, while others require a prescription, which typically includes guidelines on how to use the device.
So far, none of these portable products have been fully cleared by the FDA — although the agency did grant Breakthrough Device designation to Sooma Medical for its device to treat depression in 2023 and to Flow Neuroscience in 2022.
In August 2023, Flow announced that its device is now being reviewed for full FDA clearance on the basis of trial results showing at-home tDCS was “twice as effective” as antidepressants. The company received regulatory approval in Europe in 2019.
Other research has shown “encouraging” results for these at-home devices for conditions such as adult ADHD and pain relief with remote supervision.
Philip noted that more high-quality randomized controlled trials are definitely needed, with “a number of companies probably getting close to releasing data sometime soon.”
Is it possible that a placebo effect is at work here? “Yes, partially,” said Philip. Users often become more mindful of managing their depression and other conditions, which leads to behavior change, he said.
A Quick Fix for a Broken System?
Joseph J. Fins, MD, The E. William Davis Jr, MD, professor of Medical Ethics and chief of the Division of Medical Ethics at Weill Cornell Medicine, New York City, also believes there could be a placebo effect at play.
“It’s important that we don’t ascribe efficacy to a device without being aware of the placebo effect,” he said. That’s why more and larger, placebo-controlled trials are needed, he added.
There’s a multitude of reasons why patients may turn to at-home devices on their own, including drug shortages and the inability to see a psychiatrist in a timely manner.
“I think it speaks to the isolation of these folks that leads to them doing this on their own. These devices become a technological quick fix for a system that’s desperately broken. There’s nothing wrong with being a consumer, but at a certain point they need to be a patient, and they need to have a clinician there to help them,” he said.
Fins said that he also worries about regulatory oversight because of the way the devices are classified. He likened them to supplements, which, because they don’t make certain claims, are not regulated with the same stringency as other products and fall into an area “in between regulatory spheres.”
“I think we’re trying to take old regulatory frameworks and jerry-rig it to accommodate new and evolving technologies. And I think we need to have serious study of how we protect patients as they become consumers — to make sure there’s enough safety and enough efficacy and that they don’t get ripped off out of desperation,” Fins said.
As for safety, at-home devices are unlikely to cause physical harm — at least when used as intended. “The riskier situations happen when people build their own, overuse it, or use it in combination with drugs or alcohol or other factors that can produce unpredictable results,” Philip said.
He added that DIY-built products carry a higher risk for burns or excessive energy output. A 2016 “open letter” from a group of neurologists, published in Annals of Neurology, warned about the dangers of DIY tDCS.
In addition, Philip noted that he has seen instances where patients become manic after using at-home tDCS, especially when trying to improve cognition.
“We have seen a number of peculiar side effects emerge in those situations. Typically, it’s anxiety, panic attacks, and sensitivity to bright lights, in addition to the emergence of mania, which would require major psychiatric intervention,” he said.
“So, it’s important that if folks do engage with these sorts of things, it’s with some degree of medical involvement,” Philip added.
Ethical Considerations
Roy Hamilton, MD, professor of neurology, psychiatry, and physical medicine & rehabilitation at the University of Pennsylvania, in Philadelphia, said that in the setting of proper training, proper clinician communication, and proper oversight, he doesn’t view at-home tDCS as ethically problematic.
“For individuals who have conditions that are clearly causing them remarkable detriment to quality of life or to their health, it seems like the risk-benefit ratio with respect to the likelihood of harm is quite good,” said Hamilton, who is also the director of the Penn Brain Science, Translation, Innovation, and Modulation Center.
In addition, tDCS and other transcranial electrical stimulation techniques seem to have a better safety profile than “many of the other things we send patients home with to treat their pain,” he said.
On the other hand, this risk calculus changes in a scenario where patients are neurologically intact, he said.
The brain, Hamilton noted, exhibits functional differences based on the region undergoing stimulation. This means users should follow a specific, prescribed method. However, he pointed out that those using commercially available devices often lack clear guidance on where to place the electrodes and what intensity to use.
“This raises concerns because the way you use the device is important,” he said.
Hamilton also highlighted important ethical considerations regarding enhanced cognition through technology or pharmaceutical interventions. The possibility of coercive use raises questions about equity and fairness, particularly if individuals feel pressured to use such devices to remain competitive in academic or professional settings.
This mirrors the current issues surrounding the use of stimulants among students, where those without ADHD may feel compelled to use these drugs to improve performance. In addition, there is the possibility that the capacity to access devices that enhance cognition could exacerbate existing inequalities.
“Any time you introduce a technological intervention, you have to worry about discriminative justice. That’s where only people who can afford such devices or have access to specialists who can give them such devices get to receive improvements in their cognition,” Hamilton said.
Neither the American Academy of Neurology nor the American Psychiatric Association has established practice guidelines for tDCS, either for use in clinical settings or for use at home. Hamilton believes this is due to the current lack of data, noting that organizations likely want to see more approvals and widespread use before creating guidelines.
Fins emphasized the need for organized medicine to sponsor research, noting that the use of these devices is becoming a public health issue. He expressed concern that some devices are marketed as nonmedical interventions, despite involving medical procedures like brain stimulation. He concluded that while scrutiny is necessary, the current landscape should be approached without judgment.
Fins reported no relevant financial relationships. Philip reported serving on a scientific advisory board for Pulvinar Neuro and past involvement in clinical trials related to these devices and their use as home. Hamilton reported he is on the board of trustees for the McKnight Brain Research Foundation, which is dedicated to advancing healthy cognitive aging.
A version of this article first appeared on Medscape.com.
As at-home, do-it-yourself (DIY) brain stimulation devices like transcranial direct current stimulation (tDCS) gain popularity for common psychiatric conditions like depression, anxiety, and posttraumatic stress disorder (PTSD), questions arise about their safety and efficacy.
However, the US Food and Drug Administration (FDA) has yet to “fully” clear any of these devices and has only granted breakthrough device designation to a few. In addition, most of the portable products don’t market themselves as medical interventions, putting them into a regulatory “gray area” that has little oversight.
This has led to a free-for-all environment, allowing individuals to purchase these products online and self-administer “treatment” — often without the guidance or even knowledge of their healthcare providers.
So how effective and safe are these noninvasive brain stimulators, and what guidance, if any, should clinicians provide to patients who are or are contemplating using them at home; what does the research show, and what are the ethical considerations?
What the Research Shows
Data from studies examining unsupervised at-home and use under medical supervision are mixed. Results from a recent randomized trial of more than 200 participants showed no significant difference in safety or efficacy between adjunctive at-home tDCS and at-home sham tDCS for depressive symptoms.
“To be fair, they did not find any unexpected safety issues. What they did find was that there was no clear signal that it worked,” said Noah S. Philip, MD, professor of psychiatry and human behavior, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
Philip, who is also lead for mental health research at Brown’s Center for Neurorestoration and Neurotechnology, Providence, Rhode Island, and was not involved in the study, noted that while other research papers have shown more promising results for depression and other conditions such as adult attention-deficit/hyperactivity disorder (ADHD) and pain, they often are not placebo controlled or include large numbers of patients.
Still, he added the growing use of these devices reflects the fact that standard treatment often doesn’t meet patients’ needs.
“Broadly speaking, part of the hope with brain stimulation is that instead of taking a pill, we’re trying to more directly affect the brain tissues involved — and therefore, avoid the issue of having systemic side effects that you get from the meds. There’s certainly a hunger” for better interventions, Philip said.
tDCS involves a low-intensity electrical current applied through electrodes on the scalp in order to influence brain activity. Generally speaking, it emits less energy than other types of noninvasive brain stimulation, such as transcranial magnetic stimulation. “The trade-off is that’s it also a little harder to find a clear signal about how it works,” Philip said.
As such, he added, it’s important for clinicians to familiarize themselves with these devices, to ask about patient use, and to set up structured assessments of efficacy and adverse events.
Results from a randomized trial published last year in The Lancet showed no significant benefit for in-office use of tDCS plus a selective serotonin reuptake inhibitor vs sham tDCS for major depression.
On the other hand, a randomized trial published earlier this year in Brain Stimulation showed that older adults who received active tDCS had greater reductions in depressive and anxiety symptoms than those in the sham group.
In addition, results from a small study of eight participants published last year in SAGE Open Medicine showed adjuvant tDCS helped patients with refractory PTSD. Finally, a randomized trial of 54 veterans from Philip’s own team showed tDCS plus virtual reality was effective for combat-related PTSD.
Although there have also been several studies showing possible benefit of tDCS for Alzheimer’s disease, Gayatri Devi, MD, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, noted in a Medscape Neurology Decision Point that “the problem with all these studies is that they’re all very small, and there [are] so many different variables in terms of how you interpret response.”
On-Demand Brain Stim
As for at-home use, there’s now a wide offering of these types of devices available online, allowing an individual to apply daily brain stimulation via headsets, dispensing with the need to consult a clinician. Most are battery-powered and emit a low-level current.
Philip noted that there are essentially two ways to obtain such devices. Some are readily available from online stores, while others require a prescription, which typically includes guidelines on how to use the device.
So far, none of these portable products have been fully cleared by the FDA — although the agency did grant Breakthrough Device designation to Sooma Medical for its device to treat depression in 2023 and to Flow Neuroscience in 2022.
In August 2023, Flow announced that its device is now being reviewed for full FDA clearance on the basis of trial results showing at-home tDCS was “twice as effective” as antidepressants. The company received regulatory approval in Europe in 2019.
Other research has shown “encouraging” results for these at-home devices for conditions such as adult ADHD and pain relief with remote supervision.
Philip noted that more high-quality randomized controlled trials are definitely needed, with “a number of companies probably getting close to releasing data sometime soon.”
Is it possible that a placebo effect is at work here? “Yes, partially,” said Philip. Users often become more mindful of managing their depression and other conditions, which leads to behavior change, he said.
A Quick Fix for a Broken System?
Joseph J. Fins, MD, The E. William Davis Jr, MD, professor of Medical Ethics and chief of the Division of Medical Ethics at Weill Cornell Medicine, New York City, also believes there could be a placebo effect at play.
“It’s important that we don’t ascribe efficacy to a device without being aware of the placebo effect,” he said. That’s why more and larger, placebo-controlled trials are needed, he added.
There’s a multitude of reasons why patients may turn to at-home devices on their own, including drug shortages and the inability to see a psychiatrist in a timely manner.
“I think it speaks to the isolation of these folks that leads to them doing this on their own. These devices become a technological quick fix for a system that’s desperately broken. There’s nothing wrong with being a consumer, but at a certain point they need to be a patient, and they need to have a clinician there to help them,” he said.
Fins said that he also worries about regulatory oversight because of the way the devices are classified. He likened them to supplements, which, because they don’t make certain claims, are not regulated with the same stringency as other products and fall into an area “in between regulatory spheres.”
“I think we’re trying to take old regulatory frameworks and jerry-rig it to accommodate new and evolving technologies. And I think we need to have serious study of how we protect patients as they become consumers — to make sure there’s enough safety and enough efficacy and that they don’t get ripped off out of desperation,” Fins said.
As for safety, at-home devices are unlikely to cause physical harm — at least when used as intended. “The riskier situations happen when people build their own, overuse it, or use it in combination with drugs or alcohol or other factors that can produce unpredictable results,” Philip said.
He added that DIY-built products carry a higher risk for burns or excessive energy output. A 2016 “open letter” from a group of neurologists, published in Annals of Neurology, warned about the dangers of DIY tDCS.
In addition, Philip noted that he has seen instances where patients become manic after using at-home tDCS, especially when trying to improve cognition.
“We have seen a number of peculiar side effects emerge in those situations. Typically, it’s anxiety, panic attacks, and sensitivity to bright lights, in addition to the emergence of mania, which would require major psychiatric intervention,” he said.
“So, it’s important that if folks do engage with these sorts of things, it’s with some degree of medical involvement,” Philip added.
Ethical Considerations
Roy Hamilton, MD, professor of neurology, psychiatry, and physical medicine & rehabilitation at the University of Pennsylvania, in Philadelphia, said that in the setting of proper training, proper clinician communication, and proper oversight, he doesn’t view at-home tDCS as ethically problematic.
“For individuals who have conditions that are clearly causing them remarkable detriment to quality of life or to their health, it seems like the risk-benefit ratio with respect to the likelihood of harm is quite good,” said Hamilton, who is also the director of the Penn Brain Science, Translation, Innovation, and Modulation Center.
In addition, tDCS and other transcranial electrical stimulation techniques seem to have a better safety profile than “many of the other things we send patients home with to treat their pain,” he said.
On the other hand, this risk calculus changes in a scenario where patients are neurologically intact, he said.
The brain, Hamilton noted, exhibits functional differences based on the region undergoing stimulation. This means users should follow a specific, prescribed method. However, he pointed out that those using commercially available devices often lack clear guidance on where to place the electrodes and what intensity to use.
“This raises concerns because the way you use the device is important,” he said.
Hamilton also highlighted important ethical considerations regarding enhanced cognition through technology or pharmaceutical interventions. The possibility of coercive use raises questions about equity and fairness, particularly if individuals feel pressured to use such devices to remain competitive in academic or professional settings.
This mirrors the current issues surrounding the use of stimulants among students, where those without ADHD may feel compelled to use these drugs to improve performance. In addition, there is the possibility that the capacity to access devices that enhance cognition could exacerbate existing inequalities.
“Any time you introduce a technological intervention, you have to worry about discriminative justice. That’s where only people who can afford such devices or have access to specialists who can give them such devices get to receive improvements in their cognition,” Hamilton said.
Neither the American Academy of Neurology nor the American Psychiatric Association has established practice guidelines for tDCS, either for use in clinical settings or for use at home. Hamilton believes this is due to the current lack of data, noting that organizations likely want to see more approvals and widespread use before creating guidelines.
Fins emphasized the need for organized medicine to sponsor research, noting that the use of these devices is becoming a public health issue. He expressed concern that some devices are marketed as nonmedical interventions, despite involving medical procedures like brain stimulation. He concluded that while scrutiny is necessary, the current landscape should be approached without judgment.
Fins reported no relevant financial relationships. Philip reported serving on a scientific advisory board for Pulvinar Neuro and past involvement in clinical trials related to these devices and their use as home. Hamilton reported he is on the board of trustees for the McKnight Brain Research Foundation, which is dedicated to advancing healthy cognitive aging.
A version of this article first appeared on Medscape.com.
As at-home, do-it-yourself (DIY) brain stimulation devices like transcranial direct current stimulation (tDCS) gain popularity for common psychiatric conditions like depression, anxiety, and posttraumatic stress disorder (PTSD), questions arise about their safety and efficacy.
However, the US Food and Drug Administration (FDA) has yet to “fully” clear any of these devices and has only granted breakthrough device designation to a few. In addition, most of the portable products don’t market themselves as medical interventions, putting them into a regulatory “gray area” that has little oversight.
This has led to a free-for-all environment, allowing individuals to purchase these products online and self-administer “treatment” — often without the guidance or even knowledge of their healthcare providers.
So how effective and safe are these noninvasive brain stimulators, and what guidance, if any, should clinicians provide to patients who are or are contemplating using them at home; what does the research show, and what are the ethical considerations?
What the Research Shows
Data from studies examining unsupervised at-home and use under medical supervision are mixed. Results from a recent randomized trial of more than 200 participants showed no significant difference in safety or efficacy between adjunctive at-home tDCS and at-home sham tDCS for depressive symptoms.
“To be fair, they did not find any unexpected safety issues. What they did find was that there was no clear signal that it worked,” said Noah S. Philip, MD, professor of psychiatry and human behavior, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
Philip, who is also lead for mental health research at Brown’s Center for Neurorestoration and Neurotechnology, Providence, Rhode Island, and was not involved in the study, noted that while other research papers have shown more promising results for depression and other conditions such as adult attention-deficit/hyperactivity disorder (ADHD) and pain, they often are not placebo controlled or include large numbers of patients.
Still, he added the growing use of these devices reflects the fact that standard treatment often doesn’t meet patients’ needs.
“Broadly speaking, part of the hope with brain stimulation is that instead of taking a pill, we’re trying to more directly affect the brain tissues involved — and therefore, avoid the issue of having systemic side effects that you get from the meds. There’s certainly a hunger” for better interventions, Philip said.
tDCS involves a low-intensity electrical current applied through electrodes on the scalp in order to influence brain activity. Generally speaking, it emits less energy than other types of noninvasive brain stimulation, such as transcranial magnetic stimulation. “The trade-off is that’s it also a little harder to find a clear signal about how it works,” Philip said.
As such, he added, it’s important for clinicians to familiarize themselves with these devices, to ask about patient use, and to set up structured assessments of efficacy and adverse events.
Results from a randomized trial published last year in The Lancet showed no significant benefit for in-office use of tDCS plus a selective serotonin reuptake inhibitor vs sham tDCS for major depression.
On the other hand, a randomized trial published earlier this year in Brain Stimulation showed that older adults who received active tDCS had greater reductions in depressive and anxiety symptoms than those in the sham group.
In addition, results from a small study of eight participants published last year in SAGE Open Medicine showed adjuvant tDCS helped patients with refractory PTSD. Finally, a randomized trial of 54 veterans from Philip’s own team showed tDCS plus virtual reality was effective for combat-related PTSD.
Although there have also been several studies showing possible benefit of tDCS for Alzheimer’s disease, Gayatri Devi, MD, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, noted in a Medscape Neurology Decision Point that “the problem with all these studies is that they’re all very small, and there [are] so many different variables in terms of how you interpret response.”
On-Demand Brain Stim
As for at-home use, there’s now a wide offering of these types of devices available online, allowing an individual to apply daily brain stimulation via headsets, dispensing with the need to consult a clinician. Most are battery-powered and emit a low-level current.
Philip noted that there are essentially two ways to obtain such devices. Some are readily available from online stores, while others require a prescription, which typically includes guidelines on how to use the device.
So far, none of these portable products have been fully cleared by the FDA — although the agency did grant Breakthrough Device designation to Sooma Medical for its device to treat depression in 2023 and to Flow Neuroscience in 2022.
In August 2023, Flow announced that its device is now being reviewed for full FDA clearance on the basis of trial results showing at-home tDCS was “twice as effective” as antidepressants. The company received regulatory approval in Europe in 2019.
Other research has shown “encouraging” results for these at-home devices for conditions such as adult ADHD and pain relief with remote supervision.
Philip noted that more high-quality randomized controlled trials are definitely needed, with “a number of companies probably getting close to releasing data sometime soon.”
Is it possible that a placebo effect is at work here? “Yes, partially,” said Philip. Users often become more mindful of managing their depression and other conditions, which leads to behavior change, he said.
A Quick Fix for a Broken System?
Joseph J. Fins, MD, The E. William Davis Jr, MD, professor of Medical Ethics and chief of the Division of Medical Ethics at Weill Cornell Medicine, New York City, also believes there could be a placebo effect at play.
“It’s important that we don’t ascribe efficacy to a device without being aware of the placebo effect,” he said. That’s why more and larger, placebo-controlled trials are needed, he added.
There’s a multitude of reasons why patients may turn to at-home devices on their own, including drug shortages and the inability to see a psychiatrist in a timely manner.
“I think it speaks to the isolation of these folks that leads to them doing this on their own. These devices become a technological quick fix for a system that’s desperately broken. There’s nothing wrong with being a consumer, but at a certain point they need to be a patient, and they need to have a clinician there to help them,” he said.
Fins said that he also worries about regulatory oversight because of the way the devices are classified. He likened them to supplements, which, because they don’t make certain claims, are not regulated with the same stringency as other products and fall into an area “in between regulatory spheres.”
“I think we’re trying to take old regulatory frameworks and jerry-rig it to accommodate new and evolving technologies. And I think we need to have serious study of how we protect patients as they become consumers — to make sure there’s enough safety and enough efficacy and that they don’t get ripped off out of desperation,” Fins said.
As for safety, at-home devices are unlikely to cause physical harm — at least when used as intended. “The riskier situations happen when people build their own, overuse it, or use it in combination with drugs or alcohol or other factors that can produce unpredictable results,” Philip said.
He added that DIY-built products carry a higher risk for burns or excessive energy output. A 2016 “open letter” from a group of neurologists, published in Annals of Neurology, warned about the dangers of DIY tDCS.
In addition, Philip noted that he has seen instances where patients become manic after using at-home tDCS, especially when trying to improve cognition.
“We have seen a number of peculiar side effects emerge in those situations. Typically, it’s anxiety, panic attacks, and sensitivity to bright lights, in addition to the emergence of mania, which would require major psychiatric intervention,” he said.
“So, it’s important that if folks do engage with these sorts of things, it’s with some degree of medical involvement,” Philip added.
Ethical Considerations
Roy Hamilton, MD, professor of neurology, psychiatry, and physical medicine & rehabilitation at the University of Pennsylvania, in Philadelphia, said that in the setting of proper training, proper clinician communication, and proper oversight, he doesn’t view at-home tDCS as ethically problematic.
“For individuals who have conditions that are clearly causing them remarkable detriment to quality of life or to their health, it seems like the risk-benefit ratio with respect to the likelihood of harm is quite good,” said Hamilton, who is also the director of the Penn Brain Science, Translation, Innovation, and Modulation Center.
In addition, tDCS and other transcranial electrical stimulation techniques seem to have a better safety profile than “many of the other things we send patients home with to treat their pain,” he said.
On the other hand, this risk calculus changes in a scenario where patients are neurologically intact, he said.
The brain, Hamilton noted, exhibits functional differences based on the region undergoing stimulation. This means users should follow a specific, prescribed method. However, he pointed out that those using commercially available devices often lack clear guidance on where to place the electrodes and what intensity to use.
“This raises concerns because the way you use the device is important,” he said.
Hamilton also highlighted important ethical considerations regarding enhanced cognition through technology or pharmaceutical interventions. The possibility of coercive use raises questions about equity and fairness, particularly if individuals feel pressured to use such devices to remain competitive in academic or professional settings.
This mirrors the current issues surrounding the use of stimulants among students, where those without ADHD may feel compelled to use these drugs to improve performance. In addition, there is the possibility that the capacity to access devices that enhance cognition could exacerbate existing inequalities.
“Any time you introduce a technological intervention, you have to worry about discriminative justice. That’s where only people who can afford such devices or have access to specialists who can give them such devices get to receive improvements in their cognition,” Hamilton said.
Neither the American Academy of Neurology nor the American Psychiatric Association has established practice guidelines for tDCS, either for use in clinical settings or for use at home. Hamilton believes this is due to the current lack of data, noting that organizations likely want to see more approvals and widespread use before creating guidelines.
Fins emphasized the need for organized medicine to sponsor research, noting that the use of these devices is becoming a public health issue. He expressed concern that some devices are marketed as nonmedical interventions, despite involving medical procedures like brain stimulation. He concluded that while scrutiny is necessary, the current landscape should be approached without judgment.
Fins reported no relevant financial relationships. Philip reported serving on a scientific advisory board for Pulvinar Neuro and past involvement in clinical trials related to these devices and their use as home. Hamilton reported he is on the board of trustees for the McKnight Brain Research Foundation, which is dedicated to advancing healthy cognitive aging.
A version of this article first appeared on Medscape.com.
Death Cafes: Demystifying the Inevitable Over Tea and Cookies
“Death cafes” — where people gather to discuss death and dying over tea and cookies — have gained momentum in recent years offering a unique way for people to come together and discuss a topic that is often shrouded in discomfort and avoidance.
It’s estimated that there are now about 18,900 death cafes in 90 countries, with the United States hosting more than 9300 on a regular basis. This trend reflects a growing desire to break the taboo surrounding discussions of death and dying.
But these casual get-togethers may not be for everyone, and their potential benefits and harms may depend on who attends and who facilitates the discussion.
“These gatherings provide a supportive environment for a wide range of people, including those with terminal diagnoses, chronic illnesses, curiosity seekers, and individuals grieving the loss of loved ones,” Macke said in an interview.
How Do They Work?
These free events are typically advertised on community bulletin boards and held in public spaces. Libraries are a great spot to gather because they typically allow the host to bring in snacks and beverages, Macke noted.
She tries to host a death cafe once a month and said attendance can vary widely; some gatherings will see as few as two participants, while others draw larger groups, reflecting the varied interest levels in different times and locations, Macke said.
When hosting a death cafe, Macke said she typically introduces herself, and then asks people to introduce themselves and share what prompted them to attend, which usually triggers a discussion.
Death cafe conversations are largely participant driven, with no set agenda, allowing people to share personal stories, beliefs, and feelings related to death, often resulting in a sense of relief or community connection. “They are not therapy sessions,” Macke said.
In her experience, Macke has found that many people report feeling less anxious and fearful of death after attending a death cafe and express gratitude for the opportunity to talk about death and dying in a relaxed atmosphere.
Macke said death cafes may serve as a valuable adjunct to end-of-life care, helping patients and families process the emotional and psychological aspects of dying. Holding these discussions in nonclinical settings may help normalize these conversations outside of a medical context.
Potential Risks?
Normalizing the conversation around grief is crucial, regardless of where it takes place, Kara Rauscher, LCSW, trauma services coordinator with Nashville Cares in Tennessee, said in an interview.
“Many of the clients I’ve seen for grief counseling feel incredibly isolated in their grief. As a society, we are uncomfortable with grief and don’t always know how to hold space for people who are grieving. It is not uncommon to hear phrases like ‘move on’ or ‘just let go of it’ — but that’s just not how grief works,” Rauscher said.
“Death cafes could be very helpful for some people but may not be helpful for others and should not be viewed as a substitute for counseling or therapy with a trained mental health provider,” Rauscher cautioned.
Therese Rando, PhD, clinical psychologist and clinical director of The Institute for the Study & Treatment of Loss, Warwick, Rhode Island, also cautioned that death cafes have the potential to be helpful or harmful.
“Exposing ourselves to healthy death conversations and realizing that death is an inevitable part of life can help a person lead a more fulfilling life, prioritize things that are important to them, and recognize that there is not a limitless supply of tomorrows, so they need to make good choices,” Rando said in an interview.
But the benefits or harms that are realized depend on who is attending and who is facilitating these death cafes, she noted.
“It’s fine to have a group of people coming at it from an intellectual point of view, or even if they have had a loss, they might be able to address some of their existential or philosophical questions. But you could get somebody who’s really raw or on the edge or who has psychological issues, and a death cafe may not be suitable for them at that point,” said Rando, author of the book How to Go on Living When Someone You Love Dies.
“It must be recognized that for some people, casual discussions about death and dying could — although not necessarily will — exacerbate anxiety, if they are not facilitated by trained individuals,” Rando added.
A version of this article first appeared on Medscape.com.
“Death cafes” — where people gather to discuss death and dying over tea and cookies — have gained momentum in recent years offering a unique way for people to come together and discuss a topic that is often shrouded in discomfort and avoidance.
It’s estimated that there are now about 18,900 death cafes in 90 countries, with the United States hosting more than 9300 on a regular basis. This trend reflects a growing desire to break the taboo surrounding discussions of death and dying.
But these casual get-togethers may not be for everyone, and their potential benefits and harms may depend on who attends and who facilitates the discussion.
“These gatherings provide a supportive environment for a wide range of people, including those with terminal diagnoses, chronic illnesses, curiosity seekers, and individuals grieving the loss of loved ones,” Macke said in an interview.
How Do They Work?
These free events are typically advertised on community bulletin boards and held in public spaces. Libraries are a great spot to gather because they typically allow the host to bring in snacks and beverages, Macke noted.
She tries to host a death cafe once a month and said attendance can vary widely; some gatherings will see as few as two participants, while others draw larger groups, reflecting the varied interest levels in different times and locations, Macke said.
When hosting a death cafe, Macke said she typically introduces herself, and then asks people to introduce themselves and share what prompted them to attend, which usually triggers a discussion.
Death cafe conversations are largely participant driven, with no set agenda, allowing people to share personal stories, beliefs, and feelings related to death, often resulting in a sense of relief or community connection. “They are not therapy sessions,” Macke said.
In her experience, Macke has found that many people report feeling less anxious and fearful of death after attending a death cafe and express gratitude for the opportunity to talk about death and dying in a relaxed atmosphere.
Macke said death cafes may serve as a valuable adjunct to end-of-life care, helping patients and families process the emotional and psychological aspects of dying. Holding these discussions in nonclinical settings may help normalize these conversations outside of a medical context.
Potential Risks?
Normalizing the conversation around grief is crucial, regardless of where it takes place, Kara Rauscher, LCSW, trauma services coordinator with Nashville Cares in Tennessee, said in an interview.
“Many of the clients I’ve seen for grief counseling feel incredibly isolated in their grief. As a society, we are uncomfortable with grief and don’t always know how to hold space for people who are grieving. It is not uncommon to hear phrases like ‘move on’ or ‘just let go of it’ — but that’s just not how grief works,” Rauscher said.
“Death cafes could be very helpful for some people but may not be helpful for others and should not be viewed as a substitute for counseling or therapy with a trained mental health provider,” Rauscher cautioned.
Therese Rando, PhD, clinical psychologist and clinical director of The Institute for the Study & Treatment of Loss, Warwick, Rhode Island, also cautioned that death cafes have the potential to be helpful or harmful.
“Exposing ourselves to healthy death conversations and realizing that death is an inevitable part of life can help a person lead a more fulfilling life, prioritize things that are important to them, and recognize that there is not a limitless supply of tomorrows, so they need to make good choices,” Rando said in an interview.
But the benefits or harms that are realized depend on who is attending and who is facilitating these death cafes, she noted.
“It’s fine to have a group of people coming at it from an intellectual point of view, or even if they have had a loss, they might be able to address some of their existential or philosophical questions. But you could get somebody who’s really raw or on the edge or who has psychological issues, and a death cafe may not be suitable for them at that point,” said Rando, author of the book How to Go on Living When Someone You Love Dies.
“It must be recognized that for some people, casual discussions about death and dying could — although not necessarily will — exacerbate anxiety, if they are not facilitated by trained individuals,” Rando added.
A version of this article first appeared on Medscape.com.
“Death cafes” — where people gather to discuss death and dying over tea and cookies — have gained momentum in recent years offering a unique way for people to come together and discuss a topic that is often shrouded in discomfort and avoidance.
It’s estimated that there are now about 18,900 death cafes in 90 countries, with the United States hosting more than 9300 on a regular basis. This trend reflects a growing desire to break the taboo surrounding discussions of death and dying.
But these casual get-togethers may not be for everyone, and their potential benefits and harms may depend on who attends and who facilitates the discussion.
“These gatherings provide a supportive environment for a wide range of people, including those with terminal diagnoses, chronic illnesses, curiosity seekers, and individuals grieving the loss of loved ones,” Macke said in an interview.
How Do They Work?
These free events are typically advertised on community bulletin boards and held in public spaces. Libraries are a great spot to gather because they typically allow the host to bring in snacks and beverages, Macke noted.
She tries to host a death cafe once a month and said attendance can vary widely; some gatherings will see as few as two participants, while others draw larger groups, reflecting the varied interest levels in different times and locations, Macke said.
When hosting a death cafe, Macke said she typically introduces herself, and then asks people to introduce themselves and share what prompted them to attend, which usually triggers a discussion.
Death cafe conversations are largely participant driven, with no set agenda, allowing people to share personal stories, beliefs, and feelings related to death, often resulting in a sense of relief or community connection. “They are not therapy sessions,” Macke said.
In her experience, Macke has found that many people report feeling less anxious and fearful of death after attending a death cafe and express gratitude for the opportunity to talk about death and dying in a relaxed atmosphere.
Macke said death cafes may serve as a valuable adjunct to end-of-life care, helping patients and families process the emotional and psychological aspects of dying. Holding these discussions in nonclinical settings may help normalize these conversations outside of a medical context.
Potential Risks?
Normalizing the conversation around grief is crucial, regardless of where it takes place, Kara Rauscher, LCSW, trauma services coordinator with Nashville Cares in Tennessee, said in an interview.
“Many of the clients I’ve seen for grief counseling feel incredibly isolated in their grief. As a society, we are uncomfortable with grief and don’t always know how to hold space for people who are grieving. It is not uncommon to hear phrases like ‘move on’ or ‘just let go of it’ — but that’s just not how grief works,” Rauscher said.
“Death cafes could be very helpful for some people but may not be helpful for others and should not be viewed as a substitute for counseling or therapy with a trained mental health provider,” Rauscher cautioned.
Therese Rando, PhD, clinical psychologist and clinical director of The Institute for the Study & Treatment of Loss, Warwick, Rhode Island, also cautioned that death cafes have the potential to be helpful or harmful.
“Exposing ourselves to healthy death conversations and realizing that death is an inevitable part of life can help a person lead a more fulfilling life, prioritize things that are important to them, and recognize that there is not a limitless supply of tomorrows, so they need to make good choices,” Rando said in an interview.
But the benefits or harms that are realized depend on who is attending and who is facilitating these death cafes, she noted.
“It’s fine to have a group of people coming at it from an intellectual point of view, or even if they have had a loss, they might be able to address some of their existential or philosophical questions. But you could get somebody who’s really raw or on the edge or who has psychological issues, and a death cafe may not be suitable for them at that point,” said Rando, author of the book How to Go on Living When Someone You Love Dies.
“It must be recognized that for some people, casual discussions about death and dying could — although not necessarily will — exacerbate anxiety, if they are not facilitated by trained individuals,” Rando added.
A version of this article first appeared on Medscape.com.
Suicide Screening and Safety Plans Moved Needle on Attempts and Deaths Moving the Needle
In the winter of 2023, Cynthia Smith, MD, an internal medicine physician in Philadelphia and the chief membership and engagement officer for the American College of Physicians, treated a high-achieving, middle-aged man who said he felt completely alone and isolated.
Smith used depression and suicide screeners and found the man was actively thinking of harming himself. She and the man created a safety plan. Then, she connected her patient to a clinical social worker within her health system who helped him enter an intensive outpatient treatment program for depression.
“I am not sure if screening this patient for depression saved his life, but I do think he left the office feeling less alone and more supported than when he arrived. Screening him helped us achieve that outcome,” said Smith. “Our patient needed to know that we cared about him.”
Smith’s experience is part of a broader movement to screen patients for depression and suicide with the goal of getting people into treatment.
Prior research has shown more than 40% people who die by suicide visit a primary care clinician in the month before death, and more than 75% see a primary care physician in the year before a suicide death.
New research published in Annals of Internal Medicine showed these screening processes reduced suicide attempts and deaths by suicide by 25% in one health system.
Clinicians using screening questions to engage patients in safety planning “can know that this work is valuable, and that it will save lives,” said Julie Angerhofer, PhD, MPH, a collaborative scientist at Kaiser Permanente Washington Health Research Institute in Seattle, and a coauthor of the study. “For those who are considering investing in doing this work, it is good news because it is going to have an effect. We did not know that until we did this trial.”
Suicide is the 11th leading cause of death in the United States, accounting for 49,000 fatalities in 2022, according to the Centers for Disease Control and Prevention.
The new study findings “are significant when it comes to working with people who are at risk for suicide in primary care practice and shows that it is both feasible and effective,” said Julie Goldstein Grumet, PhD, vice president for suicide prevention strategy and director of the Zero Suicide Institute at the nonprofit Education Development Center.
Grumet said the use of standardized screening tools, like those used in the study protocol, is key.
When patients screened positive for depression with the Patient Health Questionnaire 2 (PHQ-2), they were asked to complete the additional questions of the PHQ-9. If patients reported frequent suicidal thoughts, they received a brief, self-administered version of the Columbia-Suicide Severity Rating Scale. The analysis included 333,593 patients who had 1.56 million visits for any reason to their primary care clinician.
Patients who reported some level of intent or planning for a suicide attempt in the prior month were connected to a clinical social worker for same day safety planning.
The study showed that the rate of documented fatal or nonfatal suicide attempts within 90 days of a primary care visit was 25% lower in the suicide care than in the usual care period and 24% lower in the 60 days after a visit, both statistically significant findings.
These tools help clinicians “to determine the type of care needed and to provide the right level of intervention,” Grumet said.
Both Smith and the study utilized social workers to help with safety planning. But because many clinicians do not work in integrated health systems with access to these professionals, other workflows can also support the screening and safety planning process, Angerhofer said. For instance, nurses can be trained to conduct a safety plan.
“Some systems also use centralized groups of providers trained in safety planning to support primary care teams virtually,” she said. Clinicians can also refer to free trainings on safety planning available online — including the one on the Zero Suicide website.
Smith said one of the biggest barriers to suicide care is the lack of resources needed to follow-up on a positive screen.
The study findings are “a call to action, but it can’t be the straw breaking the backs of primary care doctors; it has to be supported,” Smith said.
A safety plan includes:
- Helping patients recognize warning signs of an impending suicidal crisis
- Using social contacts as a means of distraction from suicidal thoughts
- Contacting family members or friends who may help resolve the crisis
- Contacting mental health professionals or agencies
- Making the patient’s home environment safer by reducing the potential use and availability of lethal means
The study was supported by a grant from the National Institute of Mental Health. Various study authors reported receiving consulting fees, honoraria, and grants from the University of Washington, Advocate Aurora Health, the Donaghue Medical Research Foundation’s Greater Value Portfolio program, and the Patient-Centered Outcomes Research Institute, among others.
A version of this article first appeared on Medscape.com.
In the winter of 2023, Cynthia Smith, MD, an internal medicine physician in Philadelphia and the chief membership and engagement officer for the American College of Physicians, treated a high-achieving, middle-aged man who said he felt completely alone and isolated.
Smith used depression and suicide screeners and found the man was actively thinking of harming himself. She and the man created a safety plan. Then, she connected her patient to a clinical social worker within her health system who helped him enter an intensive outpatient treatment program for depression.
“I am not sure if screening this patient for depression saved his life, but I do think he left the office feeling less alone and more supported than when he arrived. Screening him helped us achieve that outcome,” said Smith. “Our patient needed to know that we cared about him.”
Smith’s experience is part of a broader movement to screen patients for depression and suicide with the goal of getting people into treatment.
Prior research has shown more than 40% people who die by suicide visit a primary care clinician in the month before death, and more than 75% see a primary care physician in the year before a suicide death.
New research published in Annals of Internal Medicine showed these screening processes reduced suicide attempts and deaths by suicide by 25% in one health system.
Clinicians using screening questions to engage patients in safety planning “can know that this work is valuable, and that it will save lives,” said Julie Angerhofer, PhD, MPH, a collaborative scientist at Kaiser Permanente Washington Health Research Institute in Seattle, and a coauthor of the study. “For those who are considering investing in doing this work, it is good news because it is going to have an effect. We did not know that until we did this trial.”
Suicide is the 11th leading cause of death in the United States, accounting for 49,000 fatalities in 2022, according to the Centers for Disease Control and Prevention.
The new study findings “are significant when it comes to working with people who are at risk for suicide in primary care practice and shows that it is both feasible and effective,” said Julie Goldstein Grumet, PhD, vice president for suicide prevention strategy and director of the Zero Suicide Institute at the nonprofit Education Development Center.
Grumet said the use of standardized screening tools, like those used in the study protocol, is key.
When patients screened positive for depression with the Patient Health Questionnaire 2 (PHQ-2), they were asked to complete the additional questions of the PHQ-9. If patients reported frequent suicidal thoughts, they received a brief, self-administered version of the Columbia-Suicide Severity Rating Scale. The analysis included 333,593 patients who had 1.56 million visits for any reason to their primary care clinician.
Patients who reported some level of intent or planning for a suicide attempt in the prior month were connected to a clinical social worker for same day safety planning.
The study showed that the rate of documented fatal or nonfatal suicide attempts within 90 days of a primary care visit was 25% lower in the suicide care than in the usual care period and 24% lower in the 60 days after a visit, both statistically significant findings.
These tools help clinicians “to determine the type of care needed and to provide the right level of intervention,” Grumet said.
Both Smith and the study utilized social workers to help with safety planning. But because many clinicians do not work in integrated health systems with access to these professionals, other workflows can also support the screening and safety planning process, Angerhofer said. For instance, nurses can be trained to conduct a safety plan.
“Some systems also use centralized groups of providers trained in safety planning to support primary care teams virtually,” she said. Clinicians can also refer to free trainings on safety planning available online — including the one on the Zero Suicide website.
Smith said one of the biggest barriers to suicide care is the lack of resources needed to follow-up on a positive screen.
The study findings are “a call to action, but it can’t be the straw breaking the backs of primary care doctors; it has to be supported,” Smith said.
A safety plan includes:
- Helping patients recognize warning signs of an impending suicidal crisis
- Using social contacts as a means of distraction from suicidal thoughts
- Contacting family members or friends who may help resolve the crisis
- Contacting mental health professionals or agencies
- Making the patient’s home environment safer by reducing the potential use and availability of lethal means
The study was supported by a grant from the National Institute of Mental Health. Various study authors reported receiving consulting fees, honoraria, and grants from the University of Washington, Advocate Aurora Health, the Donaghue Medical Research Foundation’s Greater Value Portfolio program, and the Patient-Centered Outcomes Research Institute, among others.
A version of this article first appeared on Medscape.com.
In the winter of 2023, Cynthia Smith, MD, an internal medicine physician in Philadelphia and the chief membership and engagement officer for the American College of Physicians, treated a high-achieving, middle-aged man who said he felt completely alone and isolated.
Smith used depression and suicide screeners and found the man was actively thinking of harming himself. She and the man created a safety plan. Then, she connected her patient to a clinical social worker within her health system who helped him enter an intensive outpatient treatment program for depression.
“I am not sure if screening this patient for depression saved his life, but I do think he left the office feeling less alone and more supported than when he arrived. Screening him helped us achieve that outcome,” said Smith. “Our patient needed to know that we cared about him.”
Smith’s experience is part of a broader movement to screen patients for depression and suicide with the goal of getting people into treatment.
Prior research has shown more than 40% people who die by suicide visit a primary care clinician in the month before death, and more than 75% see a primary care physician in the year before a suicide death.
New research published in Annals of Internal Medicine showed these screening processes reduced suicide attempts and deaths by suicide by 25% in one health system.
Clinicians using screening questions to engage patients in safety planning “can know that this work is valuable, and that it will save lives,” said Julie Angerhofer, PhD, MPH, a collaborative scientist at Kaiser Permanente Washington Health Research Institute in Seattle, and a coauthor of the study. “For those who are considering investing in doing this work, it is good news because it is going to have an effect. We did not know that until we did this trial.”
Suicide is the 11th leading cause of death in the United States, accounting for 49,000 fatalities in 2022, according to the Centers for Disease Control and Prevention.
The new study findings “are significant when it comes to working with people who are at risk for suicide in primary care practice and shows that it is both feasible and effective,” said Julie Goldstein Grumet, PhD, vice president for suicide prevention strategy and director of the Zero Suicide Institute at the nonprofit Education Development Center.
Grumet said the use of standardized screening tools, like those used in the study protocol, is key.
When patients screened positive for depression with the Patient Health Questionnaire 2 (PHQ-2), they were asked to complete the additional questions of the PHQ-9. If patients reported frequent suicidal thoughts, they received a brief, self-administered version of the Columbia-Suicide Severity Rating Scale. The analysis included 333,593 patients who had 1.56 million visits for any reason to their primary care clinician.
Patients who reported some level of intent or planning for a suicide attempt in the prior month were connected to a clinical social worker for same day safety planning.
The study showed that the rate of documented fatal or nonfatal suicide attempts within 90 days of a primary care visit was 25% lower in the suicide care than in the usual care period and 24% lower in the 60 days after a visit, both statistically significant findings.
These tools help clinicians “to determine the type of care needed and to provide the right level of intervention,” Grumet said.
Both Smith and the study utilized social workers to help with safety planning. But because many clinicians do not work in integrated health systems with access to these professionals, other workflows can also support the screening and safety planning process, Angerhofer said. For instance, nurses can be trained to conduct a safety plan.
“Some systems also use centralized groups of providers trained in safety planning to support primary care teams virtually,” she said. Clinicians can also refer to free trainings on safety planning available online — including the one on the Zero Suicide website.
Smith said one of the biggest barriers to suicide care is the lack of resources needed to follow-up on a positive screen.
The study findings are “a call to action, but it can’t be the straw breaking the backs of primary care doctors; it has to be supported,” Smith said.
A safety plan includes:
- Helping patients recognize warning signs of an impending suicidal crisis
- Using social contacts as a means of distraction from suicidal thoughts
- Contacting family members or friends who may help resolve the crisis
- Contacting mental health professionals or agencies
- Making the patient’s home environment safer by reducing the potential use and availability of lethal means
The study was supported by a grant from the National Institute of Mental Health. Various study authors reported receiving consulting fees, honoraria, and grants from the University of Washington, Advocate Aurora Health, the Donaghue Medical Research Foundation’s Greater Value Portfolio program, and the Patient-Centered Outcomes Research Institute, among others.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
Long-Term Cognitive Monitoring Warranted After First Stroke
A first stroke in older adults is associated with substantial immediate and accelerated long-term cognitive decline, suggested a new study that underscores the need for continuous cognitive monitoring in this patient population.
Results from the study, which included 14 international cohorts of older adults, showed that stroke was associated with a significant acute decline in global cognition and a small, but significant, acceleration in the rate of cognitive decline over time.
Cognitive assessments in primary care are “crucial, especially since cognitive impairment is frequently missed or undiagnosed in hospitals,” lead author Jessica Lo, MSc, biostatistician and research associate with the Center for Healthy Brain Aging, University of New South Wales, Sydney, Australia, told this news organization.
She suggested clinicians incorporate long-term cognitive assessments into care plans, using more sensitive neuropsychological tests in primary care to detect early signs of cognitive impairment. “Early detection would enable timely interventions to improve outcomes,” Lo said.
She also noted that poststroke care typically includes physical rehabilitation but not cognitive rehabilitation, which many rehabilitation centers aren’t equipped to provide.
The study was published online in JAMA Network Open.
Mapping Cognitive Decline Trajectory
Cognitive impairment after stroke is common, but the trajectory of cognitive decline following a first stroke, relative to prestroke cognitive function, remains unclear.
The investigators leveraged data from 14 population-based cohort studies of 20,860 adults (mean age, 73 years; 59% women) to map the trajectory of cognitive function before and after a first stroke.
The primary outcome was global cognition, defined as the standardized average of four cognitive domains (language, memory, processing speed, and executive function).
During a mean follow-up of 7.5 years, 1041 (5%) adults (mean age, 79 years) experienced a first stroke, a mean of 4.5 years after study entry.
In adjusted analyses, stroke was associated with a significant acute decline of 0.25 SD in global cognition and a “small but significant” acceleration in the rate of decline of −0.038 SD per year, the authors reported.
Stroke was also associated with acute decline in all individual cognitive domains except for memory, with effect sizes ranging from −0.17 to −0.22 SD. Poststroke declines in Mini-Mental State Examination scores (−0.36 SD) were also noted.
In terms of cognitive trajectory, the rate of decline before stroke in survivors was similar to that seen in peers who didn’t have a stroke (−0.048 and −0.049 SD per year in global cognition, respectively).
The researchers did not identify any vascular risk factors moderating cognitive decline following a stroke, consistent with prior research. However, cognitive decline was significantly more rapid in individuals without stroke, regardless of any future stroke, who had a history of diabetes, hypertension, high cholesterol, cardiovascular disease, depression, smoking, or were APOE4 carriers.
“Targeting modifiable vascular risk factors at an early stage may reduce the risk of stroke but also subsequent risk of stroke-related cognitive decline and cognitive impairment,” the researchers noted.
A ‘Major Step’ in the Right Direction
As previously reported by this news organization, in 2023 the American Heart Association (AHA) issued a statement noting that screening for cognitive impairment should be part of multidisciplinary care for stroke survivors.
Commenting for this news organization, Mitchell Elkind, MD, MS, AHA chief clinical science officer, said these new data are consistent with current AHA guidelines and statements that “support screening for cognitive and functional decline in patients both acutely and over the long term after stroke.”
Elkind noted that the 2022 guideline for intracerebral hemorrhage states that cognitive screening should occur “across the continuum of inpatient care and at intervals in the outpatient setting” and provides recommendations for cognitive therapy.
“Our 2021 scientific statement on the primary care of patients after stroke also recommends screening for both depression and cognitive impairment over both the short- and long-term,” said Elkind, professor of neurology and epidemiology at Columbia University Irving Medical Center in New York City.
“These documents recognize the fact that function and cognition can continue to decline years after stroke and that patients’ rehabilitation and support needs may therefore change over time after stroke,” Elkind added.
The authors of an accompanying commentary called it a “major step” in the right direction for the future of long-term stroke outcome assessment.
“As we develop new devices, indications, and time windows for stroke treatment, it may perhaps be wise to ensure trials steer away from simpler outcomes to more complex, granular ones,” wrote Yasmin Sadigh, MSc, and Victor Volovici, MD, PhD, with Erasmus University Medical Center, Rotterdam, the Netherlands.
The study had no commercial funding. The authors and commentary writers and Elkind have declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
A first stroke in older adults is associated with substantial immediate and accelerated long-term cognitive decline, suggested a new study that underscores the need for continuous cognitive monitoring in this patient population.
Results from the study, which included 14 international cohorts of older adults, showed that stroke was associated with a significant acute decline in global cognition and a small, but significant, acceleration in the rate of cognitive decline over time.
Cognitive assessments in primary care are “crucial, especially since cognitive impairment is frequently missed or undiagnosed in hospitals,” lead author Jessica Lo, MSc, biostatistician and research associate with the Center for Healthy Brain Aging, University of New South Wales, Sydney, Australia, told this news organization.
She suggested clinicians incorporate long-term cognitive assessments into care plans, using more sensitive neuropsychological tests in primary care to detect early signs of cognitive impairment. “Early detection would enable timely interventions to improve outcomes,” Lo said.
She also noted that poststroke care typically includes physical rehabilitation but not cognitive rehabilitation, which many rehabilitation centers aren’t equipped to provide.
The study was published online in JAMA Network Open.
Mapping Cognitive Decline Trajectory
Cognitive impairment after stroke is common, but the trajectory of cognitive decline following a first stroke, relative to prestroke cognitive function, remains unclear.
The investigators leveraged data from 14 population-based cohort studies of 20,860 adults (mean age, 73 years; 59% women) to map the trajectory of cognitive function before and after a first stroke.
The primary outcome was global cognition, defined as the standardized average of four cognitive domains (language, memory, processing speed, and executive function).
During a mean follow-up of 7.5 years, 1041 (5%) adults (mean age, 79 years) experienced a first stroke, a mean of 4.5 years after study entry.
In adjusted analyses, stroke was associated with a significant acute decline of 0.25 SD in global cognition and a “small but significant” acceleration in the rate of decline of −0.038 SD per year, the authors reported.
Stroke was also associated with acute decline in all individual cognitive domains except for memory, with effect sizes ranging from −0.17 to −0.22 SD. Poststroke declines in Mini-Mental State Examination scores (−0.36 SD) were also noted.
In terms of cognitive trajectory, the rate of decline before stroke in survivors was similar to that seen in peers who didn’t have a stroke (−0.048 and −0.049 SD per year in global cognition, respectively).
The researchers did not identify any vascular risk factors moderating cognitive decline following a stroke, consistent with prior research. However, cognitive decline was significantly more rapid in individuals without stroke, regardless of any future stroke, who had a history of diabetes, hypertension, high cholesterol, cardiovascular disease, depression, smoking, or were APOE4 carriers.
“Targeting modifiable vascular risk factors at an early stage may reduce the risk of stroke but also subsequent risk of stroke-related cognitive decline and cognitive impairment,” the researchers noted.
A ‘Major Step’ in the Right Direction
As previously reported by this news organization, in 2023 the American Heart Association (AHA) issued a statement noting that screening for cognitive impairment should be part of multidisciplinary care for stroke survivors.
Commenting for this news organization, Mitchell Elkind, MD, MS, AHA chief clinical science officer, said these new data are consistent with current AHA guidelines and statements that “support screening for cognitive and functional decline in patients both acutely and over the long term after stroke.”
Elkind noted that the 2022 guideline for intracerebral hemorrhage states that cognitive screening should occur “across the continuum of inpatient care and at intervals in the outpatient setting” and provides recommendations for cognitive therapy.
“Our 2021 scientific statement on the primary care of patients after stroke also recommends screening for both depression and cognitive impairment over both the short- and long-term,” said Elkind, professor of neurology and epidemiology at Columbia University Irving Medical Center in New York City.
“These documents recognize the fact that function and cognition can continue to decline years after stroke and that patients’ rehabilitation and support needs may therefore change over time after stroke,” Elkind added.
The authors of an accompanying commentary called it a “major step” in the right direction for the future of long-term stroke outcome assessment.
“As we develop new devices, indications, and time windows for stroke treatment, it may perhaps be wise to ensure trials steer away from simpler outcomes to more complex, granular ones,” wrote Yasmin Sadigh, MSc, and Victor Volovici, MD, PhD, with Erasmus University Medical Center, Rotterdam, the Netherlands.
The study had no commercial funding. The authors and commentary writers and Elkind have declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
A first stroke in older adults is associated with substantial immediate and accelerated long-term cognitive decline, suggested a new study that underscores the need for continuous cognitive monitoring in this patient population.
Results from the study, which included 14 international cohorts of older adults, showed that stroke was associated with a significant acute decline in global cognition and a small, but significant, acceleration in the rate of cognitive decline over time.
Cognitive assessments in primary care are “crucial, especially since cognitive impairment is frequently missed or undiagnosed in hospitals,” lead author Jessica Lo, MSc, biostatistician and research associate with the Center for Healthy Brain Aging, University of New South Wales, Sydney, Australia, told this news organization.
She suggested clinicians incorporate long-term cognitive assessments into care plans, using more sensitive neuropsychological tests in primary care to detect early signs of cognitive impairment. “Early detection would enable timely interventions to improve outcomes,” Lo said.
She also noted that poststroke care typically includes physical rehabilitation but not cognitive rehabilitation, which many rehabilitation centers aren’t equipped to provide.
The study was published online in JAMA Network Open.
Mapping Cognitive Decline Trajectory
Cognitive impairment after stroke is common, but the trajectory of cognitive decline following a first stroke, relative to prestroke cognitive function, remains unclear.
The investigators leveraged data from 14 population-based cohort studies of 20,860 adults (mean age, 73 years; 59% women) to map the trajectory of cognitive function before and after a first stroke.
The primary outcome was global cognition, defined as the standardized average of four cognitive domains (language, memory, processing speed, and executive function).
During a mean follow-up of 7.5 years, 1041 (5%) adults (mean age, 79 years) experienced a first stroke, a mean of 4.5 years after study entry.
In adjusted analyses, stroke was associated with a significant acute decline of 0.25 SD in global cognition and a “small but significant” acceleration in the rate of decline of −0.038 SD per year, the authors reported.
Stroke was also associated with acute decline in all individual cognitive domains except for memory, with effect sizes ranging from −0.17 to −0.22 SD. Poststroke declines in Mini-Mental State Examination scores (−0.36 SD) were also noted.
In terms of cognitive trajectory, the rate of decline before stroke in survivors was similar to that seen in peers who didn’t have a stroke (−0.048 and −0.049 SD per year in global cognition, respectively).
The researchers did not identify any vascular risk factors moderating cognitive decline following a stroke, consistent with prior research. However, cognitive decline was significantly more rapid in individuals without stroke, regardless of any future stroke, who had a history of diabetes, hypertension, high cholesterol, cardiovascular disease, depression, smoking, or were APOE4 carriers.
“Targeting modifiable vascular risk factors at an early stage may reduce the risk of stroke but also subsequent risk of stroke-related cognitive decline and cognitive impairment,” the researchers noted.
A ‘Major Step’ in the Right Direction
As previously reported by this news organization, in 2023 the American Heart Association (AHA) issued a statement noting that screening for cognitive impairment should be part of multidisciplinary care for stroke survivors.
Commenting for this news organization, Mitchell Elkind, MD, MS, AHA chief clinical science officer, said these new data are consistent with current AHA guidelines and statements that “support screening for cognitive and functional decline in patients both acutely and over the long term after stroke.”
Elkind noted that the 2022 guideline for intracerebral hemorrhage states that cognitive screening should occur “across the continuum of inpatient care and at intervals in the outpatient setting” and provides recommendations for cognitive therapy.
“Our 2021 scientific statement on the primary care of patients after stroke also recommends screening for both depression and cognitive impairment over both the short- and long-term,” said Elkind, professor of neurology and epidemiology at Columbia University Irving Medical Center in New York City.
“These documents recognize the fact that function and cognition can continue to decline years after stroke and that patients’ rehabilitation and support needs may therefore change over time after stroke,” Elkind added.
The authors of an accompanying commentary called it a “major step” in the right direction for the future of long-term stroke outcome assessment.
“As we develop new devices, indications, and time windows for stroke treatment, it may perhaps be wise to ensure trials steer away from simpler outcomes to more complex, granular ones,” wrote Yasmin Sadigh, MSc, and Victor Volovici, MD, PhD, with Erasmus University Medical Center, Rotterdam, the Netherlands.
The study had no commercial funding. The authors and commentary writers and Elkind have declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
New Treatment Effective for Male Postpartum Depression
A psychosocial intervention designed to improve depressive symptoms and promote good parenting skills can be an effective way of treating male postpartum depression, according to new research.
In a study conducted in Pakistan, about 70% fathers with postpartum depression who received the intervention showed complete remission of their depressive symptoms and experienced enhanced relationships with their children and domestic partners.
Called Learning Through Play Plus Dads (LTP + Dads), the intervention, which can be delivered by community health workers, could improve paternal mental health and child development not only in Pakistan but also in other populations, the authors stated.
The results of the study were published on October 2, 2024, in JAMA Psychiatry.
Stigmatized and Understudied
“Pakistan is a patriarchal society with strict gender roles, and male mental health, particularly postpartum depression in new fathers, is stigmatized and understudied,” lead investigator Ishrat Husain, MD, a senior scientist at the Centre for Addiction and Mental Health and associate professor of psychiatry at the University of Toronto in Ontario, Canada, said in an interview.
“Historically, and rightly so, the focus has always been on the mother, but men also experience significant emotional challenges as they adapt to being a parent. Fathers are also in need of support,” said Husain.
Male postpartum depression is prevalent in all populations. Globally, about 10% fathers have postpartum depression. But in societies like Pakistan, rates of male postpartum depression have been reported to be as high as 23.5%.
The study included 357 fathers aged 18 years or older (mean age, 31.44 years) with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnosis of major depressive episode and a child younger than 30 months.
They were randomly assigned either to receive treatment as usual (n = 186) or to participate in the LTP + Dads program (n = 171). LTP + Dads is a parenting and mental health initiative adapted from a similar program for Pakistani mothers. It combines parenting skills training, play therapy, and cognitive behavioral therapy. In this study, the initiative was delivered by community health workers in 12 group sessions over 4 months. Sessions took place weekly for the first 2 months and biweekly thereafter.
The researchers assessed changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) score at 4 months and at 6 months. They also looked at anxiety symptoms; parenting stress; intimate partner violence; functioning; quality of life; and child social, emotional, and physical health outcomes.
Improved Child Development
There were significantly greater reductions in HDRS-17 scores in the LTP + Dads group than in the treatment as usual group at 4 months (group difference ratio [GDR], 0.66; P < .001) and at 6 months (GDR, 0.67; P < .001).
Similar results were seen for anxiety (GDR, 0.62; P < .001), parenting stress (GDR, −12.5; P < .001), intimate partner violence (GDR, 0.89; P = .05), disability (GDR, 0.77; P = .03), and health-related quality of life (GDR, 12.7; P < .001) at 4 months. The differences in depression and parenting stress were sustained at 6 months.
In addition, children of fathers who received the parenting intervention showed significantly greater improvements in social-emotional development scores (mean difference, −20.8; P < .001) at 6 months than children of those who received the treatment as usual.
“We believe that this program could also be successful in other countries, including Canada,” said Husain. “Canada is multicultural, and similar patterns of male postpartum depression probably exist here. We know that cultural and social pressures create barriers to seeking mental health support for men. Stigma and cultural beliefs often prevent new fathers from seeking the help they need. Programs like LTP + Dads can help men transition to their new role as fathers by giving them support to process their emotions,” he said.
Husain added that the program will be expanded throughout Pakistan to include about 4000 fathers and their partners.
‘Remarkable’ Success Rate
“Postpartum depression in men is still something that people are trying to understand,” John Ogrodniczuk, MD, professor of psychiatry and director of the psychotherapy program at The University of British Columbia, Vancouver, Canada, said in an interview. He did not participate in the study.
“Obviously, men aren’t going through the same endocrine changes that women are, but nonetheless, a lot of men do actually struggle with it,” said Ogrodniczuk, who is also the founder of HeadsUpGuys, a mental health resource for men.
“Understandably, most of the literature is around postpartum depression in women, not so much around men. The positive results seen here are interesting, especially in a country that is patriarchal and where there is not a lot of uptake of mental health interventions and services by men,” he said.
“The success rate of this psychosocial intervention is remarkable, so I am excited to see that the researchers have secured funding to expand the study and validate their results with a larger group of participants,” Simon B. Sherry, PhD, professor of psychology and neuroscience at Dalhousie University, Halifax, Nova Scotia, Canada, said in an interview.
“I am also encouraged by the inclusion of play-based activities in addition to cognitive behavioral therapy. Perhaps more than any other role we hold through life, the role of parent comes with copious societal and personal expectations, plus with all that pressure, transitioning into that role is hard for everyone, but especially for those with postpartum depression. Supporting parents and improving their mental well-being goes a long way toward raising mentally healthy kids,” said Sherry, who was not part of the study.
The study was funded by a grant from Grand Challenges Canada, an Academic Scholars Award from the Department of Psychiatry at the University of Toronto, and a Tier 2 Canada Research Chair from the Canadian Institutes of Health Research. Husain reported receiving grants from COMPASS Pathfinder, stock options from Mindset Pharma, and personal fees from Wake Network, outside the submitted work. He previously served as a trustee for the Pakistan Institute of Living and Learning. Ogrodniczuk and Sherry reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A psychosocial intervention designed to improve depressive symptoms and promote good parenting skills can be an effective way of treating male postpartum depression, according to new research.
In a study conducted in Pakistan, about 70% fathers with postpartum depression who received the intervention showed complete remission of their depressive symptoms and experienced enhanced relationships with their children and domestic partners.
Called Learning Through Play Plus Dads (LTP + Dads), the intervention, which can be delivered by community health workers, could improve paternal mental health and child development not only in Pakistan but also in other populations, the authors stated.
The results of the study were published on October 2, 2024, in JAMA Psychiatry.
Stigmatized and Understudied
“Pakistan is a patriarchal society with strict gender roles, and male mental health, particularly postpartum depression in new fathers, is stigmatized and understudied,” lead investigator Ishrat Husain, MD, a senior scientist at the Centre for Addiction and Mental Health and associate professor of psychiatry at the University of Toronto in Ontario, Canada, said in an interview.
“Historically, and rightly so, the focus has always been on the mother, but men also experience significant emotional challenges as they adapt to being a parent. Fathers are also in need of support,” said Husain.
Male postpartum depression is prevalent in all populations. Globally, about 10% fathers have postpartum depression. But in societies like Pakistan, rates of male postpartum depression have been reported to be as high as 23.5%.
The study included 357 fathers aged 18 years or older (mean age, 31.44 years) with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnosis of major depressive episode and a child younger than 30 months.
They were randomly assigned either to receive treatment as usual (n = 186) or to participate in the LTP + Dads program (n = 171). LTP + Dads is a parenting and mental health initiative adapted from a similar program for Pakistani mothers. It combines parenting skills training, play therapy, and cognitive behavioral therapy. In this study, the initiative was delivered by community health workers in 12 group sessions over 4 months. Sessions took place weekly for the first 2 months and biweekly thereafter.
The researchers assessed changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) score at 4 months and at 6 months. They also looked at anxiety symptoms; parenting stress; intimate partner violence; functioning; quality of life; and child social, emotional, and physical health outcomes.
Improved Child Development
There were significantly greater reductions in HDRS-17 scores in the LTP + Dads group than in the treatment as usual group at 4 months (group difference ratio [GDR], 0.66; P < .001) and at 6 months (GDR, 0.67; P < .001).
Similar results were seen for anxiety (GDR, 0.62; P < .001), parenting stress (GDR, −12.5; P < .001), intimate partner violence (GDR, 0.89; P = .05), disability (GDR, 0.77; P = .03), and health-related quality of life (GDR, 12.7; P < .001) at 4 months. The differences in depression and parenting stress were sustained at 6 months.
In addition, children of fathers who received the parenting intervention showed significantly greater improvements in social-emotional development scores (mean difference, −20.8; P < .001) at 6 months than children of those who received the treatment as usual.
“We believe that this program could also be successful in other countries, including Canada,” said Husain. “Canada is multicultural, and similar patterns of male postpartum depression probably exist here. We know that cultural and social pressures create barriers to seeking mental health support for men. Stigma and cultural beliefs often prevent new fathers from seeking the help they need. Programs like LTP + Dads can help men transition to their new role as fathers by giving them support to process their emotions,” he said.
Husain added that the program will be expanded throughout Pakistan to include about 4000 fathers and their partners.
‘Remarkable’ Success Rate
“Postpartum depression in men is still something that people are trying to understand,” John Ogrodniczuk, MD, professor of psychiatry and director of the psychotherapy program at The University of British Columbia, Vancouver, Canada, said in an interview. He did not participate in the study.
“Obviously, men aren’t going through the same endocrine changes that women are, but nonetheless, a lot of men do actually struggle with it,” said Ogrodniczuk, who is also the founder of HeadsUpGuys, a mental health resource for men.
“Understandably, most of the literature is around postpartum depression in women, not so much around men. The positive results seen here are interesting, especially in a country that is patriarchal and where there is not a lot of uptake of mental health interventions and services by men,” he said.
“The success rate of this psychosocial intervention is remarkable, so I am excited to see that the researchers have secured funding to expand the study and validate their results with a larger group of participants,” Simon B. Sherry, PhD, professor of psychology and neuroscience at Dalhousie University, Halifax, Nova Scotia, Canada, said in an interview.
“I am also encouraged by the inclusion of play-based activities in addition to cognitive behavioral therapy. Perhaps more than any other role we hold through life, the role of parent comes with copious societal and personal expectations, plus with all that pressure, transitioning into that role is hard for everyone, but especially for those with postpartum depression. Supporting parents and improving their mental well-being goes a long way toward raising mentally healthy kids,” said Sherry, who was not part of the study.
The study was funded by a grant from Grand Challenges Canada, an Academic Scholars Award from the Department of Psychiatry at the University of Toronto, and a Tier 2 Canada Research Chair from the Canadian Institutes of Health Research. Husain reported receiving grants from COMPASS Pathfinder, stock options from Mindset Pharma, and personal fees from Wake Network, outside the submitted work. He previously served as a trustee for the Pakistan Institute of Living and Learning. Ogrodniczuk and Sherry reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A psychosocial intervention designed to improve depressive symptoms and promote good parenting skills can be an effective way of treating male postpartum depression, according to new research.
In a study conducted in Pakistan, about 70% fathers with postpartum depression who received the intervention showed complete remission of their depressive symptoms and experienced enhanced relationships with their children and domestic partners.
Called Learning Through Play Plus Dads (LTP + Dads), the intervention, which can be delivered by community health workers, could improve paternal mental health and child development not only in Pakistan but also in other populations, the authors stated.
The results of the study were published on October 2, 2024, in JAMA Psychiatry.
Stigmatized and Understudied
“Pakistan is a patriarchal society with strict gender roles, and male mental health, particularly postpartum depression in new fathers, is stigmatized and understudied,” lead investigator Ishrat Husain, MD, a senior scientist at the Centre for Addiction and Mental Health and associate professor of psychiatry at the University of Toronto in Ontario, Canada, said in an interview.
“Historically, and rightly so, the focus has always been on the mother, but men also experience significant emotional challenges as they adapt to being a parent. Fathers are also in need of support,” said Husain.
Male postpartum depression is prevalent in all populations. Globally, about 10% fathers have postpartum depression. But in societies like Pakistan, rates of male postpartum depression have been reported to be as high as 23.5%.
The study included 357 fathers aged 18 years or older (mean age, 31.44 years) with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnosis of major depressive episode and a child younger than 30 months.
They were randomly assigned either to receive treatment as usual (n = 186) or to participate in the LTP + Dads program (n = 171). LTP + Dads is a parenting and mental health initiative adapted from a similar program for Pakistani mothers. It combines parenting skills training, play therapy, and cognitive behavioral therapy. In this study, the initiative was delivered by community health workers in 12 group sessions over 4 months. Sessions took place weekly for the first 2 months and biweekly thereafter.
The researchers assessed changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) score at 4 months and at 6 months. They also looked at anxiety symptoms; parenting stress; intimate partner violence; functioning; quality of life; and child social, emotional, and physical health outcomes.
Improved Child Development
There were significantly greater reductions in HDRS-17 scores in the LTP + Dads group than in the treatment as usual group at 4 months (group difference ratio [GDR], 0.66; P < .001) and at 6 months (GDR, 0.67; P < .001).
Similar results were seen for anxiety (GDR, 0.62; P < .001), parenting stress (GDR, −12.5; P < .001), intimate partner violence (GDR, 0.89; P = .05), disability (GDR, 0.77; P = .03), and health-related quality of life (GDR, 12.7; P < .001) at 4 months. The differences in depression and parenting stress were sustained at 6 months.
In addition, children of fathers who received the parenting intervention showed significantly greater improvements in social-emotional development scores (mean difference, −20.8; P < .001) at 6 months than children of those who received the treatment as usual.
“We believe that this program could also be successful in other countries, including Canada,” said Husain. “Canada is multicultural, and similar patterns of male postpartum depression probably exist here. We know that cultural and social pressures create barriers to seeking mental health support for men. Stigma and cultural beliefs often prevent new fathers from seeking the help they need. Programs like LTP + Dads can help men transition to their new role as fathers by giving them support to process their emotions,” he said.
Husain added that the program will be expanded throughout Pakistan to include about 4000 fathers and their partners.
‘Remarkable’ Success Rate
“Postpartum depression in men is still something that people are trying to understand,” John Ogrodniczuk, MD, professor of psychiatry and director of the psychotherapy program at The University of British Columbia, Vancouver, Canada, said in an interview. He did not participate in the study.
“Obviously, men aren’t going through the same endocrine changes that women are, but nonetheless, a lot of men do actually struggle with it,” said Ogrodniczuk, who is also the founder of HeadsUpGuys, a mental health resource for men.
“Understandably, most of the literature is around postpartum depression in women, not so much around men. The positive results seen here are interesting, especially in a country that is patriarchal and where there is not a lot of uptake of mental health interventions and services by men,” he said.
“The success rate of this psychosocial intervention is remarkable, so I am excited to see that the researchers have secured funding to expand the study and validate their results with a larger group of participants,” Simon B. Sherry, PhD, professor of psychology and neuroscience at Dalhousie University, Halifax, Nova Scotia, Canada, said in an interview.
“I am also encouraged by the inclusion of play-based activities in addition to cognitive behavioral therapy. Perhaps more than any other role we hold through life, the role of parent comes with copious societal and personal expectations, plus with all that pressure, transitioning into that role is hard for everyone, but especially for those with postpartum depression. Supporting parents and improving their mental well-being goes a long way toward raising mentally healthy kids,” said Sherry, who was not part of the study.
The study was funded by a grant from Grand Challenges Canada, an Academic Scholars Award from the Department of Psychiatry at the University of Toronto, and a Tier 2 Canada Research Chair from the Canadian Institutes of Health Research. Husain reported receiving grants from COMPASS Pathfinder, stock options from Mindset Pharma, and personal fees from Wake Network, outside the submitted work. He previously served as a trustee for the Pakistan Institute of Living and Learning. Ogrodniczuk and Sherry reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA PSYCHIATRY
What Are the Best Tools for Early Childhood Developmental Concerns?
Early recognition of neurodevelopmental concerns and timely access to services have been shown to result in better outcomes for young children. But not all instruments are of equal value, and new research has sought to identify the most useful among them.
For their research, published online in Developmental Medicine & Child Neurology, Andrea Burgess, PhD, of the University of Queensland in Brisbane, Australia, and her colleagues looked at two decades’ worth of systematic reviews of screening, assessment, and diagnostic tools used in children younger than 6 years.
Eighty-six clinical reviews and six practice guidelines, all published between 2000 and 2023, were included in the scoping review, which covered nearly 250 different multi-domain and domain- and disorder-specific tools.
The diagnostic instruments were those used to diagnose the most common early childhood disorders, including intellectual disability, global developmental delay, communication disorders, autism spectrum disorder, attention-deficit/hyperactivity disorder, cerebral palsy, movement disorders, and fetal alcohol spectrum disorder. Burgess and her colleagues sought to determine which tools had the strongest evidence behind them, noting that comparisons were inherently limited by differences in the tested populations, cutoff values, and other factors.
Burgess and her colleagues identified 67 instruments — about a third of those analyzed in the study — “with good discriminative or predictive validity for the screening and assessment of developmental concerns or disability.” Recommended tools were classified by tool type and by patient age groups.
The reason a tool might not be recommended, Burgess said in an email, was for lack of psychometric testing or published evidence, or because the tool was very narrow in scope (eg, covering only a single aspect of a domain), had a small time window for use, or was too new to have been captured in published systematic reviews.
Top Recommendations
Among multi-domain assessment tools, the Bayley Scales of Infant and Toddler Development, the Battelle Developmental Inventory, and the Mullen Scales of Early Learning all emerged as highly recommended. The top diagnostic screening tool for autism was the revised version of Social Attention and Communication Surveillance. For cerebral palsy, the top-rated diagnostic assessment tools were Prechtl’s Qualitative Assessment of General Movements and the Hammersmith Infant Neurological Examination.
Ratifying findings by other groups, the researchers determined the Ages & Stages Questionnaires, Third Edition (ASQ-3) to be the best overall multi-domain screening instrument for early childhood development, thanks to its simplicity and ease of use by a wide range of practitioner types. Burgess and her colleagues noted, however, that the ASQ-3 “will not identify all children with developmental concerns and may incorrectly identify others,” and that it may be more accurate in children 2 years or older.
Patient Care Setting and Cultural, Socioeconomic Factors Are Key
This news organization spoke to two clinicians working with these and similar tools in the United States. Both said that the care setting can also influence the utility of tools, with cultural and socioeconomic factors playing important roles.
Liz Schwandt, PsyD, an early intervention specialist in Los Angeles, said in an interview that children living in high-risk communities in the United States have a larger burden of developmental delays. But for many families in these communities, accessing care can be complex, which is why well-designed, efficient screening tools like ASQ-3 are especially valuable in practice.
“The reality is you have 10 minutes with a lot of families, and if it’s an emergency, you need to know,” she said. “The ASQ-3 has a very broad age range for this type of instrument and can be used by different practitioner types. The reason it’s successful lies in its parent-centric approach and inherent ease of use. It’s quick, and you can score it using pencil and paper while chatting with the parent, and you can use it for multiple siblings in the space of one appointment.”
With very young children, in whom neurodevelopmental concerns often overlap domains, Schwandt said it can be more important to flag a potential problem early and initiate a nonspecific developmental intervention than wait for results from more precise assessments using more specialized tools. These often require multiple, multi-hour appointments, which can be difficult to attain in lower-resource settings in the United States and can delay care, she said.
Liza Mackintosh, MD, a pediatrician at a federally funded healthcare center in Los Angeles that serves mostly publicly insured families, called validated first-line screening tools “incredibly important.” While rates of developmental screenings in pediatric clinics are increasing, there is still room for improvement, she said.
Mackintosh’s institution does not currently use the ASQ-3 but a different screening tool, called the Survey of Well-Being of Young Children (SWYC), that is embedded into the electronic health record. (The SWYC was not among the tools highlighted in Burgess and colleagues’ review.) Like the ASQ-3, it is short and efficient, she said, and it is used in all children in the recommended age ranges.
“Our visits are on average only 20 minutes,” Mackintosh said. “There’s not enough time for an in-depth developmental assessment. We will flag things such as a speech delay, gross motor delay, or fine motor delay” and refer to early intervention centers for more in-depth developmental assessments as needed, she said.
“The biggest job of pediatricians working in communities that are under-resourced is advocating for those early intervention services,” Mackintosh added. “We really see our job as doing the recommended screening, putting that together with what we’re seeing clinically and on history, and then advocating for the right next step or early intervention. Because sometimes the diagnosis is — I don’t want to say irrelevant, but your treatment plan is still going to be the same. So while I don’t have a formal diagnosis yet, the child definitely needs therapies and we’re still going to get those therapies.”
Burgess and her colleagues stressed in their paper the importance of selecting tools that are culturally appropriate for Indigenous communities in Australia, noting that “inappropriate tools may lead to over- or under-recognition of children with developmental concerns.”
Schwandt and Mackintosh said that the same applies in US settings.
“We’ve done a good job translating screening tools into Chinese, Spanish, Vietnamese, and Russian,” Schwandt said. “But some of them assume a way of taking care of children that is not always shared across cultures. The expectations of how children should play and interact with adults can be very different, and there needs to be an understanding of that. Just putting something in Vietnamese doesn’t mean that there are obvious analogues to understanding what the questionnaire is asking.”
Mackintosh concurred. “A lot of times our patients will not do well on screening, even though they’re fine, because they don’t have the exposure to that activity that’s being asked about. So — is the child scribbling with crayons? Is she climbing up a ladder at a playground? In order to be able to do that, you need to have an environment that you are doing it in. The screeners have to really be appropriate for what the child is exposed to. And sometimes our patients just don’t have that exposure.”
Burgess and colleagues’ study was funded by the Australian government and the Merchant Charitable Foundation. The authors disclosed no financial conflicts of interest. Schwandt and Mackintosh disclosed no conflicts of interest related to their comments.
A version of this article appeared on Medscape.com.
Early recognition of neurodevelopmental concerns and timely access to services have been shown to result in better outcomes for young children. But not all instruments are of equal value, and new research has sought to identify the most useful among them.
For their research, published online in Developmental Medicine & Child Neurology, Andrea Burgess, PhD, of the University of Queensland in Brisbane, Australia, and her colleagues looked at two decades’ worth of systematic reviews of screening, assessment, and diagnostic tools used in children younger than 6 years.
Eighty-six clinical reviews and six practice guidelines, all published between 2000 and 2023, were included in the scoping review, which covered nearly 250 different multi-domain and domain- and disorder-specific tools.
The diagnostic instruments were those used to diagnose the most common early childhood disorders, including intellectual disability, global developmental delay, communication disorders, autism spectrum disorder, attention-deficit/hyperactivity disorder, cerebral palsy, movement disorders, and fetal alcohol spectrum disorder. Burgess and her colleagues sought to determine which tools had the strongest evidence behind them, noting that comparisons were inherently limited by differences in the tested populations, cutoff values, and other factors.
Burgess and her colleagues identified 67 instruments — about a third of those analyzed in the study — “with good discriminative or predictive validity for the screening and assessment of developmental concerns or disability.” Recommended tools were classified by tool type and by patient age groups.
The reason a tool might not be recommended, Burgess said in an email, was for lack of psychometric testing or published evidence, or because the tool was very narrow in scope (eg, covering only a single aspect of a domain), had a small time window for use, or was too new to have been captured in published systematic reviews.
Top Recommendations
Among multi-domain assessment tools, the Bayley Scales of Infant and Toddler Development, the Battelle Developmental Inventory, and the Mullen Scales of Early Learning all emerged as highly recommended. The top diagnostic screening tool for autism was the revised version of Social Attention and Communication Surveillance. For cerebral palsy, the top-rated diagnostic assessment tools were Prechtl’s Qualitative Assessment of General Movements and the Hammersmith Infant Neurological Examination.
Ratifying findings by other groups, the researchers determined the Ages & Stages Questionnaires, Third Edition (ASQ-3) to be the best overall multi-domain screening instrument for early childhood development, thanks to its simplicity and ease of use by a wide range of practitioner types. Burgess and her colleagues noted, however, that the ASQ-3 “will not identify all children with developmental concerns and may incorrectly identify others,” and that it may be more accurate in children 2 years or older.
Patient Care Setting and Cultural, Socioeconomic Factors Are Key
This news organization spoke to two clinicians working with these and similar tools in the United States. Both said that the care setting can also influence the utility of tools, with cultural and socioeconomic factors playing important roles.
Liz Schwandt, PsyD, an early intervention specialist in Los Angeles, said in an interview that children living in high-risk communities in the United States have a larger burden of developmental delays. But for many families in these communities, accessing care can be complex, which is why well-designed, efficient screening tools like ASQ-3 are especially valuable in practice.
“The reality is you have 10 minutes with a lot of families, and if it’s an emergency, you need to know,” she said. “The ASQ-3 has a very broad age range for this type of instrument and can be used by different practitioner types. The reason it’s successful lies in its parent-centric approach and inherent ease of use. It’s quick, and you can score it using pencil and paper while chatting with the parent, and you can use it for multiple siblings in the space of one appointment.”
With very young children, in whom neurodevelopmental concerns often overlap domains, Schwandt said it can be more important to flag a potential problem early and initiate a nonspecific developmental intervention than wait for results from more precise assessments using more specialized tools. These often require multiple, multi-hour appointments, which can be difficult to attain in lower-resource settings in the United States and can delay care, she said.
Liza Mackintosh, MD, a pediatrician at a federally funded healthcare center in Los Angeles that serves mostly publicly insured families, called validated first-line screening tools “incredibly important.” While rates of developmental screenings in pediatric clinics are increasing, there is still room for improvement, she said.
Mackintosh’s institution does not currently use the ASQ-3 but a different screening tool, called the Survey of Well-Being of Young Children (SWYC), that is embedded into the electronic health record. (The SWYC was not among the tools highlighted in Burgess and colleagues’ review.) Like the ASQ-3, it is short and efficient, she said, and it is used in all children in the recommended age ranges.
“Our visits are on average only 20 minutes,” Mackintosh said. “There’s not enough time for an in-depth developmental assessment. We will flag things such as a speech delay, gross motor delay, or fine motor delay” and refer to early intervention centers for more in-depth developmental assessments as needed, she said.
“The biggest job of pediatricians working in communities that are under-resourced is advocating for those early intervention services,” Mackintosh added. “We really see our job as doing the recommended screening, putting that together with what we’re seeing clinically and on history, and then advocating for the right next step or early intervention. Because sometimes the diagnosis is — I don’t want to say irrelevant, but your treatment plan is still going to be the same. So while I don’t have a formal diagnosis yet, the child definitely needs therapies and we’re still going to get those therapies.”
Burgess and her colleagues stressed in their paper the importance of selecting tools that are culturally appropriate for Indigenous communities in Australia, noting that “inappropriate tools may lead to over- or under-recognition of children with developmental concerns.”
Schwandt and Mackintosh said that the same applies in US settings.
“We’ve done a good job translating screening tools into Chinese, Spanish, Vietnamese, and Russian,” Schwandt said. “But some of them assume a way of taking care of children that is not always shared across cultures. The expectations of how children should play and interact with adults can be very different, and there needs to be an understanding of that. Just putting something in Vietnamese doesn’t mean that there are obvious analogues to understanding what the questionnaire is asking.”
Mackintosh concurred. “A lot of times our patients will not do well on screening, even though they’re fine, because they don’t have the exposure to that activity that’s being asked about. So — is the child scribbling with crayons? Is she climbing up a ladder at a playground? In order to be able to do that, you need to have an environment that you are doing it in. The screeners have to really be appropriate for what the child is exposed to. And sometimes our patients just don’t have that exposure.”
Burgess and colleagues’ study was funded by the Australian government and the Merchant Charitable Foundation. The authors disclosed no financial conflicts of interest. Schwandt and Mackintosh disclosed no conflicts of interest related to their comments.
A version of this article appeared on Medscape.com.
Early recognition of neurodevelopmental concerns and timely access to services have been shown to result in better outcomes for young children. But not all instruments are of equal value, and new research has sought to identify the most useful among them.
For their research, published online in Developmental Medicine & Child Neurology, Andrea Burgess, PhD, of the University of Queensland in Brisbane, Australia, and her colleagues looked at two decades’ worth of systematic reviews of screening, assessment, and diagnostic tools used in children younger than 6 years.
Eighty-six clinical reviews and six practice guidelines, all published between 2000 and 2023, were included in the scoping review, which covered nearly 250 different multi-domain and domain- and disorder-specific tools.
The diagnostic instruments were those used to diagnose the most common early childhood disorders, including intellectual disability, global developmental delay, communication disorders, autism spectrum disorder, attention-deficit/hyperactivity disorder, cerebral palsy, movement disorders, and fetal alcohol spectrum disorder. Burgess and her colleagues sought to determine which tools had the strongest evidence behind them, noting that comparisons were inherently limited by differences in the tested populations, cutoff values, and other factors.
Burgess and her colleagues identified 67 instruments — about a third of those analyzed in the study — “with good discriminative or predictive validity for the screening and assessment of developmental concerns or disability.” Recommended tools were classified by tool type and by patient age groups.
The reason a tool might not be recommended, Burgess said in an email, was for lack of psychometric testing or published evidence, or because the tool was very narrow in scope (eg, covering only a single aspect of a domain), had a small time window for use, or was too new to have been captured in published systematic reviews.
Top Recommendations
Among multi-domain assessment tools, the Bayley Scales of Infant and Toddler Development, the Battelle Developmental Inventory, and the Mullen Scales of Early Learning all emerged as highly recommended. The top diagnostic screening tool for autism was the revised version of Social Attention and Communication Surveillance. For cerebral palsy, the top-rated diagnostic assessment tools were Prechtl’s Qualitative Assessment of General Movements and the Hammersmith Infant Neurological Examination.
Ratifying findings by other groups, the researchers determined the Ages & Stages Questionnaires, Third Edition (ASQ-3) to be the best overall multi-domain screening instrument for early childhood development, thanks to its simplicity and ease of use by a wide range of practitioner types. Burgess and her colleagues noted, however, that the ASQ-3 “will not identify all children with developmental concerns and may incorrectly identify others,” and that it may be more accurate in children 2 years or older.
Patient Care Setting and Cultural, Socioeconomic Factors Are Key
This news organization spoke to two clinicians working with these and similar tools in the United States. Both said that the care setting can also influence the utility of tools, with cultural and socioeconomic factors playing important roles.
Liz Schwandt, PsyD, an early intervention specialist in Los Angeles, said in an interview that children living in high-risk communities in the United States have a larger burden of developmental delays. But for many families in these communities, accessing care can be complex, which is why well-designed, efficient screening tools like ASQ-3 are especially valuable in practice.
“The reality is you have 10 minutes with a lot of families, and if it’s an emergency, you need to know,” she said. “The ASQ-3 has a very broad age range for this type of instrument and can be used by different practitioner types. The reason it’s successful lies in its parent-centric approach and inherent ease of use. It’s quick, and you can score it using pencil and paper while chatting with the parent, and you can use it for multiple siblings in the space of one appointment.”
With very young children, in whom neurodevelopmental concerns often overlap domains, Schwandt said it can be more important to flag a potential problem early and initiate a nonspecific developmental intervention than wait for results from more precise assessments using more specialized tools. These often require multiple, multi-hour appointments, which can be difficult to attain in lower-resource settings in the United States and can delay care, she said.
Liza Mackintosh, MD, a pediatrician at a federally funded healthcare center in Los Angeles that serves mostly publicly insured families, called validated first-line screening tools “incredibly important.” While rates of developmental screenings in pediatric clinics are increasing, there is still room for improvement, she said.
Mackintosh’s institution does not currently use the ASQ-3 but a different screening tool, called the Survey of Well-Being of Young Children (SWYC), that is embedded into the electronic health record. (The SWYC was not among the tools highlighted in Burgess and colleagues’ review.) Like the ASQ-3, it is short and efficient, she said, and it is used in all children in the recommended age ranges.
“Our visits are on average only 20 minutes,” Mackintosh said. “There’s not enough time for an in-depth developmental assessment. We will flag things such as a speech delay, gross motor delay, or fine motor delay” and refer to early intervention centers for more in-depth developmental assessments as needed, she said.
“The biggest job of pediatricians working in communities that are under-resourced is advocating for those early intervention services,” Mackintosh added. “We really see our job as doing the recommended screening, putting that together with what we’re seeing clinically and on history, and then advocating for the right next step or early intervention. Because sometimes the diagnosis is — I don’t want to say irrelevant, but your treatment plan is still going to be the same. So while I don’t have a formal diagnosis yet, the child definitely needs therapies and we’re still going to get those therapies.”
Burgess and her colleagues stressed in their paper the importance of selecting tools that are culturally appropriate for Indigenous communities in Australia, noting that “inappropriate tools may lead to over- or under-recognition of children with developmental concerns.”
Schwandt and Mackintosh said that the same applies in US settings.
“We’ve done a good job translating screening tools into Chinese, Spanish, Vietnamese, and Russian,” Schwandt said. “But some of them assume a way of taking care of children that is not always shared across cultures. The expectations of how children should play and interact with adults can be very different, and there needs to be an understanding of that. Just putting something in Vietnamese doesn’t mean that there are obvious analogues to understanding what the questionnaire is asking.”
Mackintosh concurred. “A lot of times our patients will not do well on screening, even though they’re fine, because they don’t have the exposure to that activity that’s being asked about. So — is the child scribbling with crayons? Is she climbing up a ladder at a playground? In order to be able to do that, you need to have an environment that you are doing it in. The screeners have to really be appropriate for what the child is exposed to. And sometimes our patients just don’t have that exposure.”
Burgess and colleagues’ study was funded by the Australian government and the Merchant Charitable Foundation. The authors disclosed no financial conflicts of interest. Schwandt and Mackintosh disclosed no conflicts of interest related to their comments.
A version of this article appeared on Medscape.com.
SAFE: Ensuring Access for Children With Neurodevelopmental Disabilities
We pediatricians consider ourselves as compassionate professionals, optimistic about the potential of all children. This is reflected in the American Academy of Pediatrics’ equity statement of “its mission to ensure the health and well-being of all children. This includes promoting nurturing, inclusive environments and actively opposing intolerance, bigotry, bias, and discrimination.”
A committee of the Developmental Behavioral Pediatric Network developed and published a consensus statement specifically about problems in the care of individuals with neurodevelopmental disabilities (NDD) called the Supporting Access for Everyone (SAFE) initiative. All of us care for children with NDD as one in six are affected with these conditions that impact cognition, communication, motor, social, and/or behavior skills such as autism, ADHD, intellectual disabilities (ID), learning disorders, hearing or vision impairment, and motor disabilities such as cerebral palsy. Children with NDD are overrepresented in our daily practice schedule due to their multiple medical, behavioral, and social needs. NDD are also more common among marginalized children with racial, ethnic, sexual, or gender identity minority status compounding their difficulties in accessing quality care.
NDD present similar challenges to care as other chronic conditions that also require longer visits, more documentation, long-term monitoring, team-based care, care coordination, and often referrals. But most chronic medical conditions we care for such as asthma, diabetes, cancer, hypertension, and renal disease have clear national guidelines and appropriate billing codes and are not stigmatizing. Most also do not intrinsically affect the nervous system or cause disability as for NDD that alter the behavioral presentation of the individual in a way that changes their care.
Discrimination against individuals with NDD and other disabilities, called “ableism,” can take many forms: assuming a child with communication difficulty or ID is unable to understand explanations about their care; the presence of one NDD condition ending the clinician’s search for other issues; complicated problems or difficult behaviors in the medical setting truncating care, etc.
Adjustments Needed for Special Needs
As pediatricians we already adjust our interactions, starting instinctively, to the development level of the child we perceive before us. We approach infants slowly and softly, we speak in shorter sentences to toddlers, we joke around with school-aged children, and we take extra care about privacy with teens. This serves the relationships well for neurotypical children. But our (and our staff’s) perceptions of children with autism, ID, genetic syndromes that include NDD, or motor disabilities based on their behavioral presentation may not accurately recognize or accommodate their abilities or needs. Communication and environmental adjustments may need to be much more individualized to provide respectful care, comfort and even safety.
As an example, at this time 1 in 36 children have autism with or without ID. Defining features of autism include differences in social communication, repetitive or restrictive interests or behaviors, and hypersensitivity to the environment plus any coexisting conditions such as anxiety and hyperactivity. But most children with autism have completely age appropriate and typical physical appearance and their underlying condition may not even be known. The office setting, without special attention to the needs of a child with autism, may be frightening, loud, too bright, too crowded, fast paced, and confusing. The result of their sensitivities and difficulty communicating may lead to increased agitation, repetitive behaviors (sometimes called “stimming”), shrieking, attempts to escape the room, refusal to allow for vital signs or undressing, even aggression. Strategies for calming a neurotypical child such as talking or touching may make matters worse instead of better. We need help from the child and family and a plan to optimize their medical encounters.
If not adequately accommodated, children with many varieties of NDD end up not getting all the routine healthcare they need (eg vaccinations, blood tests, vital signs, even complete physical exams including dental) as well as having more adverse events during health care, including traumatizing seclusion, not allowing a support person to be present, restraint, injuries, and accidents. When more complex procedures are needed, eg x-ray, MRI, EEG, lab studies, or surgery, successful outcomes may be lower. Children with NDD have higher rates of often avoidable morbidity and mortality than those without, in part due to these barriers to complete care. While environmental accommodations to wheelchair users for accessibility has greatly improved in recent years, access to other kinds of individualized accommodations have lagged behind.
Accommodation Planning
There are a variety of factors that need to be taken into consideration in accommodating an individual with NDD. The family becomes the expert, along with the child, in knowing the child’s triggers, preferences, abilities, and level of understanding to accept and consent for care. An accommodation plan should be created using shared and supported decision making with the family and child and allowing for child preferences, regardless of their ability level, whenever possible. Development of an accommodation plan may benefit from multidisciplinary input, eg psychology, physical therapy, speech pathology, depending on the child’s needs and the practice’s ability to adapt.
The SAFE initiative is in the process of creating a checklist aiming to facilitate a description being created for each individual to help plan for a successful medical encounter while optimizing the child’s comfort, participation, and safety. While the checklist is not yet ready, we can start now by asking families and children in preparation for or at the start of a visit about their needs and writing a shared document that can also be placed in the electronic health record for the entire care team for informing care going forward.
It is especially important for the family to keep a copy of the care plan and for it to be sent as part of referrals for procedures or specialty visits so that the professionals can prepare and adapt the encounter. An excellent example is a how some hospitals schedule a practice visit for the child to experience the sights and sounds and people the child will encounter, for example, before an EEG, when nothing is required of the child. Scheduling the actual procedure at times of day when clinics are less crowded and wait times are shorter can improve the chances of success.
Some categories and details that might be included in an accommodation plan are listed below:
You might start the plan with the child’s preferred name/nickname, family member or support person names, and diagnoses along with a brief overview of the child’s level of functioning. Then list categories of needs and preferences along with suggestions or requests.
- Motor: Does the child have or need assistance entering the building, visit room, bathroom, or transferring to the exam table? What kind of assistance, if any, and by whom?
- Sensory: Is the child disturbed by noise, lights, or being touched? Does the child want to use equipment to be comfortable such as headphones, earplugs, or sunglasses or need a quiet room, care without perfumes, or dimmed lighting? Does the child typically refuse aspects of the physical examination?
- Behavioral regulation: What helps the child to stay calm? Are there certain triggers to becoming upset? Are there early cues that an upset is coming? What and who can help in the case of an upset?
- Habits/preferences: Are there certain comfort objects or habits your child needs? Are there habits your child needs to do, such as a certain order of events, or use of social stories or pictures, to cooperate or feel comfortable?
- Communication: How does the child make his/her needs known? Does the child/family speak English or another language? Does he/she use sign language or an augmentative communication device? What level of understanding does your child have; for example, similar to what age for a typical child? Is there a care plan with accommodations already available that needs review or needs revision with the child’s development or is a new one needed? Was the care plan developed including the child’s participation and assent or is more collaboration needed?
- History: Has your child had any very upsetting experiences in healthcare settings? What happened? Has the trauma been addressed? Are there reminders of the trauma that should be avoided?
- Other: Are there other things we should know about your child as an individual to provide the best care?
There are many actions needed to do better at ensuring equitable care for individuals with NDD. We should educate our office and medical staff about NDD in children and the importance of accommodating their needs, and ways to do it. The morning huddle can be used to remind staff of upcoming visits of children who may need accommodations. We then need to use quality improvement methods to check in periodically on how the changes are working for the children, families, and practice in order to continually improve.
The overall healthcare system also needs to change. Billing codes should reflect the time, complexity of accommodations, and documentation that were required for care. Episodes of the visit may need to be broken up within the day or over several days to allow the child to practice, calm down, and cooperate and this should be accounted for in billing. Given that NDD are generally lifelong conditions, payment systems that require measures of progress such as value-based payment based on improved outcomes will need to be adjusted to measure quality of care rather than significant progress.
We need to advocate for both individual children and for system changes to work toward equity of care for those with disabilities to make their lives more comfortable as well as ours.
Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.
We pediatricians consider ourselves as compassionate professionals, optimistic about the potential of all children. This is reflected in the American Academy of Pediatrics’ equity statement of “its mission to ensure the health and well-being of all children. This includes promoting nurturing, inclusive environments and actively opposing intolerance, bigotry, bias, and discrimination.”
A committee of the Developmental Behavioral Pediatric Network developed and published a consensus statement specifically about problems in the care of individuals with neurodevelopmental disabilities (NDD) called the Supporting Access for Everyone (SAFE) initiative. All of us care for children with NDD as one in six are affected with these conditions that impact cognition, communication, motor, social, and/or behavior skills such as autism, ADHD, intellectual disabilities (ID), learning disorders, hearing or vision impairment, and motor disabilities such as cerebral palsy. Children with NDD are overrepresented in our daily practice schedule due to their multiple medical, behavioral, and social needs. NDD are also more common among marginalized children with racial, ethnic, sexual, or gender identity minority status compounding their difficulties in accessing quality care.
NDD present similar challenges to care as other chronic conditions that also require longer visits, more documentation, long-term monitoring, team-based care, care coordination, and often referrals. But most chronic medical conditions we care for such as asthma, diabetes, cancer, hypertension, and renal disease have clear national guidelines and appropriate billing codes and are not stigmatizing. Most also do not intrinsically affect the nervous system or cause disability as for NDD that alter the behavioral presentation of the individual in a way that changes their care.
Discrimination against individuals with NDD and other disabilities, called “ableism,” can take many forms: assuming a child with communication difficulty or ID is unable to understand explanations about their care; the presence of one NDD condition ending the clinician’s search for other issues; complicated problems or difficult behaviors in the medical setting truncating care, etc.
Adjustments Needed for Special Needs
As pediatricians we already adjust our interactions, starting instinctively, to the development level of the child we perceive before us. We approach infants slowly and softly, we speak in shorter sentences to toddlers, we joke around with school-aged children, and we take extra care about privacy with teens. This serves the relationships well for neurotypical children. But our (and our staff’s) perceptions of children with autism, ID, genetic syndromes that include NDD, or motor disabilities based on their behavioral presentation may not accurately recognize or accommodate their abilities or needs. Communication and environmental adjustments may need to be much more individualized to provide respectful care, comfort and even safety.
As an example, at this time 1 in 36 children have autism with or without ID. Defining features of autism include differences in social communication, repetitive or restrictive interests or behaviors, and hypersensitivity to the environment plus any coexisting conditions such as anxiety and hyperactivity. But most children with autism have completely age appropriate and typical physical appearance and their underlying condition may not even be known. The office setting, without special attention to the needs of a child with autism, may be frightening, loud, too bright, too crowded, fast paced, and confusing. The result of their sensitivities and difficulty communicating may lead to increased agitation, repetitive behaviors (sometimes called “stimming”), shrieking, attempts to escape the room, refusal to allow for vital signs or undressing, even aggression. Strategies for calming a neurotypical child such as talking or touching may make matters worse instead of better. We need help from the child and family and a plan to optimize their medical encounters.
If not adequately accommodated, children with many varieties of NDD end up not getting all the routine healthcare they need (eg vaccinations, blood tests, vital signs, even complete physical exams including dental) as well as having more adverse events during health care, including traumatizing seclusion, not allowing a support person to be present, restraint, injuries, and accidents. When more complex procedures are needed, eg x-ray, MRI, EEG, lab studies, or surgery, successful outcomes may be lower. Children with NDD have higher rates of often avoidable morbidity and mortality than those without, in part due to these barriers to complete care. While environmental accommodations to wheelchair users for accessibility has greatly improved in recent years, access to other kinds of individualized accommodations have lagged behind.
Accommodation Planning
There are a variety of factors that need to be taken into consideration in accommodating an individual with NDD. The family becomes the expert, along with the child, in knowing the child’s triggers, preferences, abilities, and level of understanding to accept and consent for care. An accommodation plan should be created using shared and supported decision making with the family and child and allowing for child preferences, regardless of their ability level, whenever possible. Development of an accommodation plan may benefit from multidisciplinary input, eg psychology, physical therapy, speech pathology, depending on the child’s needs and the practice’s ability to adapt.
The SAFE initiative is in the process of creating a checklist aiming to facilitate a description being created for each individual to help plan for a successful medical encounter while optimizing the child’s comfort, participation, and safety. While the checklist is not yet ready, we can start now by asking families and children in preparation for or at the start of a visit about their needs and writing a shared document that can also be placed in the electronic health record for the entire care team for informing care going forward.
It is especially important for the family to keep a copy of the care plan and for it to be sent as part of referrals for procedures or specialty visits so that the professionals can prepare and adapt the encounter. An excellent example is a how some hospitals schedule a practice visit for the child to experience the sights and sounds and people the child will encounter, for example, before an EEG, when nothing is required of the child. Scheduling the actual procedure at times of day when clinics are less crowded and wait times are shorter can improve the chances of success.
Some categories and details that might be included in an accommodation plan are listed below:
You might start the plan with the child’s preferred name/nickname, family member or support person names, and diagnoses along with a brief overview of the child’s level of functioning. Then list categories of needs and preferences along with suggestions or requests.
- Motor: Does the child have or need assistance entering the building, visit room, bathroom, or transferring to the exam table? What kind of assistance, if any, and by whom?
- Sensory: Is the child disturbed by noise, lights, or being touched? Does the child want to use equipment to be comfortable such as headphones, earplugs, or sunglasses or need a quiet room, care without perfumes, or dimmed lighting? Does the child typically refuse aspects of the physical examination?
- Behavioral regulation: What helps the child to stay calm? Are there certain triggers to becoming upset? Are there early cues that an upset is coming? What and who can help in the case of an upset?
- Habits/preferences: Are there certain comfort objects or habits your child needs? Are there habits your child needs to do, such as a certain order of events, or use of social stories or pictures, to cooperate or feel comfortable?
- Communication: How does the child make his/her needs known? Does the child/family speak English or another language? Does he/she use sign language or an augmentative communication device? What level of understanding does your child have; for example, similar to what age for a typical child? Is there a care plan with accommodations already available that needs review or needs revision with the child’s development or is a new one needed? Was the care plan developed including the child’s participation and assent or is more collaboration needed?
- History: Has your child had any very upsetting experiences in healthcare settings? What happened? Has the trauma been addressed? Are there reminders of the trauma that should be avoided?
- Other: Are there other things we should know about your child as an individual to provide the best care?
There are many actions needed to do better at ensuring equitable care for individuals with NDD. We should educate our office and medical staff about NDD in children and the importance of accommodating their needs, and ways to do it. The morning huddle can be used to remind staff of upcoming visits of children who may need accommodations. We then need to use quality improvement methods to check in periodically on how the changes are working for the children, families, and practice in order to continually improve.
The overall healthcare system also needs to change. Billing codes should reflect the time, complexity of accommodations, and documentation that were required for care. Episodes of the visit may need to be broken up within the day or over several days to allow the child to practice, calm down, and cooperate and this should be accounted for in billing. Given that NDD are generally lifelong conditions, payment systems that require measures of progress such as value-based payment based on improved outcomes will need to be adjusted to measure quality of care rather than significant progress.
We need to advocate for both individual children and for system changes to work toward equity of care for those with disabilities to make their lives more comfortable as well as ours.
Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.
We pediatricians consider ourselves as compassionate professionals, optimistic about the potential of all children. This is reflected in the American Academy of Pediatrics’ equity statement of “its mission to ensure the health and well-being of all children. This includes promoting nurturing, inclusive environments and actively opposing intolerance, bigotry, bias, and discrimination.”
A committee of the Developmental Behavioral Pediatric Network developed and published a consensus statement specifically about problems in the care of individuals with neurodevelopmental disabilities (NDD) called the Supporting Access for Everyone (SAFE) initiative. All of us care for children with NDD as one in six are affected with these conditions that impact cognition, communication, motor, social, and/or behavior skills such as autism, ADHD, intellectual disabilities (ID), learning disorders, hearing or vision impairment, and motor disabilities such as cerebral palsy. Children with NDD are overrepresented in our daily practice schedule due to their multiple medical, behavioral, and social needs. NDD are also more common among marginalized children with racial, ethnic, sexual, or gender identity minority status compounding their difficulties in accessing quality care.
NDD present similar challenges to care as other chronic conditions that also require longer visits, more documentation, long-term monitoring, team-based care, care coordination, and often referrals. But most chronic medical conditions we care for such as asthma, diabetes, cancer, hypertension, and renal disease have clear national guidelines and appropriate billing codes and are not stigmatizing. Most also do not intrinsically affect the nervous system or cause disability as for NDD that alter the behavioral presentation of the individual in a way that changes their care.
Discrimination against individuals with NDD and other disabilities, called “ableism,” can take many forms: assuming a child with communication difficulty or ID is unable to understand explanations about their care; the presence of one NDD condition ending the clinician’s search for other issues; complicated problems or difficult behaviors in the medical setting truncating care, etc.
Adjustments Needed for Special Needs
As pediatricians we already adjust our interactions, starting instinctively, to the development level of the child we perceive before us. We approach infants slowly and softly, we speak in shorter sentences to toddlers, we joke around with school-aged children, and we take extra care about privacy with teens. This serves the relationships well for neurotypical children. But our (and our staff’s) perceptions of children with autism, ID, genetic syndromes that include NDD, or motor disabilities based on their behavioral presentation may not accurately recognize or accommodate their abilities or needs. Communication and environmental adjustments may need to be much more individualized to provide respectful care, comfort and even safety.
As an example, at this time 1 in 36 children have autism with or without ID. Defining features of autism include differences in social communication, repetitive or restrictive interests or behaviors, and hypersensitivity to the environment plus any coexisting conditions such as anxiety and hyperactivity. But most children with autism have completely age appropriate and typical physical appearance and their underlying condition may not even be known. The office setting, without special attention to the needs of a child with autism, may be frightening, loud, too bright, too crowded, fast paced, and confusing. The result of their sensitivities and difficulty communicating may lead to increased agitation, repetitive behaviors (sometimes called “stimming”), shrieking, attempts to escape the room, refusal to allow for vital signs or undressing, even aggression. Strategies for calming a neurotypical child such as talking or touching may make matters worse instead of better. We need help from the child and family and a plan to optimize their medical encounters.
If not adequately accommodated, children with many varieties of NDD end up not getting all the routine healthcare they need (eg vaccinations, blood tests, vital signs, even complete physical exams including dental) as well as having more adverse events during health care, including traumatizing seclusion, not allowing a support person to be present, restraint, injuries, and accidents. When more complex procedures are needed, eg x-ray, MRI, EEG, lab studies, or surgery, successful outcomes may be lower. Children with NDD have higher rates of often avoidable morbidity and mortality than those without, in part due to these barriers to complete care. While environmental accommodations to wheelchair users for accessibility has greatly improved in recent years, access to other kinds of individualized accommodations have lagged behind.
Accommodation Planning
There are a variety of factors that need to be taken into consideration in accommodating an individual with NDD. The family becomes the expert, along with the child, in knowing the child’s triggers, preferences, abilities, and level of understanding to accept and consent for care. An accommodation plan should be created using shared and supported decision making with the family and child and allowing for child preferences, regardless of their ability level, whenever possible. Development of an accommodation plan may benefit from multidisciplinary input, eg psychology, physical therapy, speech pathology, depending on the child’s needs and the practice’s ability to adapt.
The SAFE initiative is in the process of creating a checklist aiming to facilitate a description being created for each individual to help plan for a successful medical encounter while optimizing the child’s comfort, participation, and safety. While the checklist is not yet ready, we can start now by asking families and children in preparation for or at the start of a visit about their needs and writing a shared document that can also be placed in the electronic health record for the entire care team for informing care going forward.
It is especially important for the family to keep a copy of the care plan and for it to be sent as part of referrals for procedures or specialty visits so that the professionals can prepare and adapt the encounter. An excellent example is a how some hospitals schedule a practice visit for the child to experience the sights and sounds and people the child will encounter, for example, before an EEG, when nothing is required of the child. Scheduling the actual procedure at times of day when clinics are less crowded and wait times are shorter can improve the chances of success.
Some categories and details that might be included in an accommodation plan are listed below:
You might start the plan with the child’s preferred name/nickname, family member or support person names, and diagnoses along with a brief overview of the child’s level of functioning. Then list categories of needs and preferences along with suggestions or requests.
- Motor: Does the child have or need assistance entering the building, visit room, bathroom, or transferring to the exam table? What kind of assistance, if any, and by whom?
- Sensory: Is the child disturbed by noise, lights, or being touched? Does the child want to use equipment to be comfortable such as headphones, earplugs, or sunglasses or need a quiet room, care without perfumes, or dimmed lighting? Does the child typically refuse aspects of the physical examination?
- Behavioral regulation: What helps the child to stay calm? Are there certain triggers to becoming upset? Are there early cues that an upset is coming? What and who can help in the case of an upset?
- Habits/preferences: Are there certain comfort objects or habits your child needs? Are there habits your child needs to do, such as a certain order of events, or use of social stories or pictures, to cooperate or feel comfortable?
- Communication: How does the child make his/her needs known? Does the child/family speak English or another language? Does he/she use sign language or an augmentative communication device? What level of understanding does your child have; for example, similar to what age for a typical child? Is there a care plan with accommodations already available that needs review or needs revision with the child’s development or is a new one needed? Was the care plan developed including the child’s participation and assent or is more collaboration needed?
- History: Has your child had any very upsetting experiences in healthcare settings? What happened? Has the trauma been addressed? Are there reminders of the trauma that should be avoided?
- Other: Are there other things we should know about your child as an individual to provide the best care?
There are many actions needed to do better at ensuring equitable care for individuals with NDD. We should educate our office and medical staff about NDD in children and the importance of accommodating their needs, and ways to do it. The morning huddle can be used to remind staff of upcoming visits of children who may need accommodations. We then need to use quality improvement methods to check in periodically on how the changes are working for the children, families, and practice in order to continually improve.
The overall healthcare system also needs to change. Billing codes should reflect the time, complexity of accommodations, and documentation that were required for care. Episodes of the visit may need to be broken up within the day or over several days to allow the child to practice, calm down, and cooperate and this should be accounted for in billing. Given that NDD are generally lifelong conditions, payment systems that require measures of progress such as value-based payment based on improved outcomes will need to be adjusted to measure quality of care rather than significant progress.
We need to advocate for both individual children and for system changes to work toward equity of care for those with disabilities to make their lives more comfortable as well as ours.
Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.
FDA Antidepressant Warnings Tied to Increase in Suicidality
, a new analysis suggests.
Investigators said the totality of evidence supports “reevaluation and possible replacement” of the US Food and Drug Administration (FDA) black box warning with routine warnings in product labeling.
“The sudden, simultaneous, and sweeping effects of these warnings — the reduction in depression treatment and increase in suicide — are documented across 14 years of strong research. The consistency in observed harms and absence of observed benefits after the black box warnings indicate this is not a coincidence,” lead author Stephen Soumerai, ScD, professor of population medicine, Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, said in a news release.
The study was published online in Health Affairs.
How Did We Get Here?
In October 2003, the FDA warned that antidepressants may be associated with suicidality among people younger than age 18 years soon after starting treatment. In January 2005, the FDA required a permanent black box warning of this risk on product labels and in television and print advertising for all antidepressant drugs.
In May 2007, the FDA expanded the 2005 black box warning to include young adults through age 24, and this broader warning remains in effect today.
Dr. Soumerai and colleagues evaluated the intended and unintended outcomes of the youth antidepressant warnings through a systematic review of “the most credible evidence in the field,” Dr. Soumerai said.
Through an exhaustive literature search, the researchers identified 34 studies of depression and suicide-related outcomes published in peer-reviewed journals after the warnings were issued.
Eleven of these studies measured abrupt changes in outcome trends following the warnings and were included in their analyses. These outcomes included monitoring for suicidality, physician visits for depression, depression diagnoses, psychotherapy visits, antidepressant treatment and use and psychotropic drug poisonings (a proxy for suicide attempts), and suicide deaths.
More Harms Than Benefits
Four studies, with more than 12 million patients, found “consistent evidence of sudden and substantial” long-term declines in doctor visits for depression and depression diagnoses after the FDA warnings, the study team noted.
These studies showed increases in physician visits for depression and depression diagnoses in the years before the warnings and abrupt, sustained declines, ranging from 20% to 45%, in visits and diagnoses after the warnings. “Some spillover occurred in comparison groups of adults, who were not targeted by the FDA warnings,” the study team said.
Seven studies revealed evidence that the FDA warnings were followed by abrupt reductions in antidepressant treatment and use, ranging from 20% to 50%. Most of these studies showed increasing use of antidepressants in the years before the FDA warnings, followed by abrupt and sustained reductions in use afterward.
Three studies found evidence of declining or flat trends in psychotropic drug poisonings and suicide deaths among pediatric patients before the warnings, followed by abrupt increases in these trends after the warnings were issued.
The intent of the warnings was to increase physician monitoring of suicidality of patients treated with antidepressants, but the data suggest that this did not occur.
Less than 5% of pediatric patients were monitored in accordance with FDA’s recommended contact schedule recommendations after the warnings were issued. This low rate was unchanged from the rate before the warnings.
No study documented improvements in mental health care or declines in suicide attempts or suicides after the warnings went into effect.
“The overwhelming evidence suggests that the ongoing use of these warnings may result in more harms than benefits,” the authors wrote.
Concerning Data
The results are “very concerning and provide reason to pause, rethink, and possibly recalibrate boxed warning recommendations as it relates to antidepressants in younger populations,” said Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Canada, and head of the Mood Disorders Psychopharmacology Unit.
Dr. McIntyre, who wasn’t involved in the study, said the data “unfortunately” provide evidence suggesting that the boxed warning had the “unintended consequence of increasing the likelihood that persons would not receive adequate healthcare for their mental disorder, consequently resulting in unfavorable outcomes, including suicidality.”
He added, “Two decades have now passed with additional information available, which not only appears to recalibrate the initial risk assessment but provides an opportunity for us to reduce the externality of decreasing access to healthcare for people living with mental illness during their youth years.”
A spokesperson for the FDA said that “generally, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”
The study had no commercial funding. Disclosures for the authors are listed with the original article. Dr. McIntyre has received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, and Neurocrine.
A version of this article appeared on Medscape.com.
, a new analysis suggests.
Investigators said the totality of evidence supports “reevaluation and possible replacement” of the US Food and Drug Administration (FDA) black box warning with routine warnings in product labeling.
“The sudden, simultaneous, and sweeping effects of these warnings — the reduction in depression treatment and increase in suicide — are documented across 14 years of strong research. The consistency in observed harms and absence of observed benefits after the black box warnings indicate this is not a coincidence,” lead author Stephen Soumerai, ScD, professor of population medicine, Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, said in a news release.
The study was published online in Health Affairs.
How Did We Get Here?
In October 2003, the FDA warned that antidepressants may be associated with suicidality among people younger than age 18 years soon after starting treatment. In January 2005, the FDA required a permanent black box warning of this risk on product labels and in television and print advertising for all antidepressant drugs.
In May 2007, the FDA expanded the 2005 black box warning to include young adults through age 24, and this broader warning remains in effect today.
Dr. Soumerai and colleagues evaluated the intended and unintended outcomes of the youth antidepressant warnings through a systematic review of “the most credible evidence in the field,” Dr. Soumerai said.
Through an exhaustive literature search, the researchers identified 34 studies of depression and suicide-related outcomes published in peer-reviewed journals after the warnings were issued.
Eleven of these studies measured abrupt changes in outcome trends following the warnings and were included in their analyses. These outcomes included monitoring for suicidality, physician visits for depression, depression diagnoses, psychotherapy visits, antidepressant treatment and use and psychotropic drug poisonings (a proxy for suicide attempts), and suicide deaths.
More Harms Than Benefits
Four studies, with more than 12 million patients, found “consistent evidence of sudden and substantial” long-term declines in doctor visits for depression and depression diagnoses after the FDA warnings, the study team noted.
These studies showed increases in physician visits for depression and depression diagnoses in the years before the warnings and abrupt, sustained declines, ranging from 20% to 45%, in visits and diagnoses after the warnings. “Some spillover occurred in comparison groups of adults, who were not targeted by the FDA warnings,” the study team said.
Seven studies revealed evidence that the FDA warnings were followed by abrupt reductions in antidepressant treatment and use, ranging from 20% to 50%. Most of these studies showed increasing use of antidepressants in the years before the FDA warnings, followed by abrupt and sustained reductions in use afterward.
Three studies found evidence of declining or flat trends in psychotropic drug poisonings and suicide deaths among pediatric patients before the warnings, followed by abrupt increases in these trends after the warnings were issued.
The intent of the warnings was to increase physician monitoring of suicidality of patients treated with antidepressants, but the data suggest that this did not occur.
Less than 5% of pediatric patients were monitored in accordance with FDA’s recommended contact schedule recommendations after the warnings were issued. This low rate was unchanged from the rate before the warnings.
No study documented improvements in mental health care or declines in suicide attempts or suicides after the warnings went into effect.
“The overwhelming evidence suggests that the ongoing use of these warnings may result in more harms than benefits,” the authors wrote.
Concerning Data
The results are “very concerning and provide reason to pause, rethink, and possibly recalibrate boxed warning recommendations as it relates to antidepressants in younger populations,” said Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Canada, and head of the Mood Disorders Psychopharmacology Unit.
Dr. McIntyre, who wasn’t involved in the study, said the data “unfortunately” provide evidence suggesting that the boxed warning had the “unintended consequence of increasing the likelihood that persons would not receive adequate healthcare for their mental disorder, consequently resulting in unfavorable outcomes, including suicidality.”
He added, “Two decades have now passed with additional information available, which not only appears to recalibrate the initial risk assessment but provides an opportunity for us to reduce the externality of decreasing access to healthcare for people living with mental illness during their youth years.”
A spokesperson for the FDA said that “generally, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”
The study had no commercial funding. Disclosures for the authors are listed with the original article. Dr. McIntyre has received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, and Neurocrine.
A version of this article appeared on Medscape.com.
, a new analysis suggests.
Investigators said the totality of evidence supports “reevaluation and possible replacement” of the US Food and Drug Administration (FDA) black box warning with routine warnings in product labeling.
“The sudden, simultaneous, and sweeping effects of these warnings — the reduction in depression treatment and increase in suicide — are documented across 14 years of strong research. The consistency in observed harms and absence of observed benefits after the black box warnings indicate this is not a coincidence,” lead author Stephen Soumerai, ScD, professor of population medicine, Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, said in a news release.
The study was published online in Health Affairs.
How Did We Get Here?
In October 2003, the FDA warned that antidepressants may be associated with suicidality among people younger than age 18 years soon after starting treatment. In January 2005, the FDA required a permanent black box warning of this risk on product labels and in television and print advertising for all antidepressant drugs.
In May 2007, the FDA expanded the 2005 black box warning to include young adults through age 24, and this broader warning remains in effect today.
Dr. Soumerai and colleagues evaluated the intended and unintended outcomes of the youth antidepressant warnings through a systematic review of “the most credible evidence in the field,” Dr. Soumerai said.
Through an exhaustive literature search, the researchers identified 34 studies of depression and suicide-related outcomes published in peer-reviewed journals after the warnings were issued.
Eleven of these studies measured abrupt changes in outcome trends following the warnings and were included in their analyses. These outcomes included monitoring for suicidality, physician visits for depression, depression diagnoses, psychotherapy visits, antidepressant treatment and use and psychotropic drug poisonings (a proxy for suicide attempts), and suicide deaths.
More Harms Than Benefits
Four studies, with more than 12 million patients, found “consistent evidence of sudden and substantial” long-term declines in doctor visits for depression and depression diagnoses after the FDA warnings, the study team noted.
These studies showed increases in physician visits for depression and depression diagnoses in the years before the warnings and abrupt, sustained declines, ranging from 20% to 45%, in visits and diagnoses after the warnings. “Some spillover occurred in comparison groups of adults, who were not targeted by the FDA warnings,” the study team said.
Seven studies revealed evidence that the FDA warnings were followed by abrupt reductions in antidepressant treatment and use, ranging from 20% to 50%. Most of these studies showed increasing use of antidepressants in the years before the FDA warnings, followed by abrupt and sustained reductions in use afterward.
Three studies found evidence of declining or flat trends in psychotropic drug poisonings and suicide deaths among pediatric patients before the warnings, followed by abrupt increases in these trends after the warnings were issued.
The intent of the warnings was to increase physician monitoring of suicidality of patients treated with antidepressants, but the data suggest that this did not occur.
Less than 5% of pediatric patients were monitored in accordance with FDA’s recommended contact schedule recommendations after the warnings were issued. This low rate was unchanged from the rate before the warnings.
No study documented improvements in mental health care or declines in suicide attempts or suicides after the warnings went into effect.
“The overwhelming evidence suggests that the ongoing use of these warnings may result in more harms than benefits,” the authors wrote.
Concerning Data
The results are “very concerning and provide reason to pause, rethink, and possibly recalibrate boxed warning recommendations as it relates to antidepressants in younger populations,” said Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Canada, and head of the Mood Disorders Psychopharmacology Unit.
Dr. McIntyre, who wasn’t involved in the study, said the data “unfortunately” provide evidence suggesting that the boxed warning had the “unintended consequence of increasing the likelihood that persons would not receive adequate healthcare for their mental disorder, consequently resulting in unfavorable outcomes, including suicidality.”
He added, “Two decades have now passed with additional information available, which not only appears to recalibrate the initial risk assessment but provides an opportunity for us to reduce the externality of decreasing access to healthcare for people living with mental illness during their youth years.”
A spokesperson for the FDA said that “generally, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”
The study had no commercial funding. Disclosures for the authors are listed with the original article. Dr. McIntyre has received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, and Neurocrine.
A version of this article appeared on Medscape.com.
From Health Affairs
Ghost Fat: The Unseen Consequences of Weight Loss
Many people who lose weight, whether through diet and lifestyle changes, medication, or bariatric surgery, recognize their body has changed. While they also experience improvements in quality of life and psychosocial areas, that’s not true for everyone. Some patients don’t “see” they’ve lost weight — a phenomenon referred to as “phantom fat,” “ghost fat,” or “vestigial body image.”
“Most people are happy with their appearance, or at least their body shape, after weight loss — although some are unhappy with the loose, sagging skin that can follow weight loss and seek plastic surgery to remedy that,” David B. Sarwer, PhD, director of the Center for Obesity Research and Education and professor of social and behavioral sciences, Temple University College of Public Health, Philadelphia, told this news organization. “There’s a subset of people who remain dissatisfied with their body image, including their shape.”
This body dissatisfaction of people who lose weight may be long-standing, predating the weight loss, or may be new because weight loss has catalyzed a host of previously unaddressed psychosocial issues. Some may show up at assessments on treatment onset, while others may be detected by monitoring changes during or after weight loss. “Mental health counseling after bariatric surgery is greatly underutilized,” Dr. Sarwer observed.
Ghost Fat
Research has corroborated the lingering self-perception of being “obese” vs “ex-obese.” In one study, patients who had undergone bariatric surgery reported being unable to see the difference in their size and shape 18-30 months following their procedure, despite substantial weight loss.
Some research suggests that rapid weight loss (eg, through bariatric surgery) is more likely to generate the perception of “phantom fat,” but additional research is needed to investigate whether the mode and speed of weight loss affect subsequent body image.
Being habituated to one’s former appearance may play a role, Dr. Sarwer suggested. “We see this not only with weight loss but with other body-altering procedures. It takes the brain time to catch up to the new appearance. In rhinoplasty, for example, it may take patients a while before they become accustomed to looking at their new face in the mirror after decades of looking at a more prominent nose.”
Years of Social Stigma
It may also take time for people to overcome years of enduring the stigma of obesity.
There are “pervasive” negative attitudes implying that individuals who are overweight and/or obese are “lazy, weak-willed, lacking in self-discipline and willpower” — a problem compounded by social media and media in general, which present unrealistic, glorified body images and disparaging messages about those with weight problems.
“Body image is a construct, rather than what you see in the mirror,” Sheethal Reddy, PhD, a psychologist at the Emory Bariatric Center, Emory University Hospital Midtown, Atlanta, told this news organization. “It’s the mental construct of our physical selves.”
According to Dr. Reddy, body image develops “within a broader societal context and is influenced by the person’s ethnic, racial, and cultural heritage.”
Adolescents are particularly vulnerable to body dissatisfaction. This is compounded in those with obesity, who often experience weight-based victimization and internalized weight-based stigma, compared with adolescents with lower weights. Weight stigma often takes the form of teasing and bullying.
“Appearance-related bullying and teasing during childhood and adolescence can reverberate into adulthood and persist throughout the lifespan,” Dr. Sarwer said. “When we see these patients and ask if they’ve ever been teased or bullied, not only do many say yes but it takes them back to those moments, to that origin story, and they remember someone saying something mean, cruel, and hurtful.”
Stigmatizing experiences can affect subjective body image, even after the weight has been lost and the person’s body is objectively thinner. Research comparing individuals who were overweight and lost weight to individuals who are currently overweight and haven’t lost weight and individuals who were never overweight suggests that “vestigial” body disparagement may persist following weight loss — especially in those with early-onset obesity.
The Role of Genetics
Genetics may contribute to people’s self-perception and body dissatisfaction, both before and after weight loss. A study of 827 community-based adolescents examined the association between polygenic risk scores (PRS) for body mass index (BMI) and type 2 diabetes and symptoms of body dissatisfaction and depression.
“Given the significant genetic role in BMI, we wanted to explore whether genetic risk for BMI might also predict body dissatisfaction,” lead author Krista Ekberg, MS, a doctoral candidate in clinical psychology, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, told this news organization.
Genetic influences on BMI, as measured by PRS, were significantly associated with both phenotypic BMI and body dissatisfaction. “The association between PRS and body dissatisfaction was largely explained by BMI, suggesting that BMI itself accounts for much of the link between genetic risk and body dissatisfaction.”
Psychiatric History and Trauma
Adverse experiences, particularly sexual or physical abuse, may also account for body dissatisfaction after weight loss. “When some people with a history of this type of abuse lose a large amount of weight — typically after bariatric surgery — they often go through a period of emotional turbulence,” Dr. Sarwer said.
Childhood maltreatment can also be associated with body image disturbances in adulthood, according to a meta-analysis of 12 studies, encompassing 15,481 participants. Sexual abuse is “surprisingly common” among patients with obesity, according to Dr. Sarwer. A chart review of 131 patients revealed that 60% of those who reported a history of rape or sexual molestation were ≥ 50 pounds overweight vs only 28% of age- and sex-matched controls without a history of abuse. Other studies have corroborated these findings.
Excess weight can serve an “adaptive function,” Dr. Sarwer noted. It can be a self-protective mechanism that “insulates” them from sexual advances by potential romantic partners or abusers. Some may find that, after weight loss, repressed memories of a sexual assault surface as a result of the newer, more “attractive” appearance. Feeling vulnerable in their thinner bodies, they may need to regard themselves as overweight to maintain that feeling of “protection.” Weight loss may also trigger memories, flashbacks, or nightmares, as people return to a weight at which they were abused.
Dissociation is another mechanism linking trauma with post–weight loss body dysmorphia, Supatra Tovar, PsyD, RD, a clinical psychologist and registered dietitian with a practice in California, told this news organization. Dissociation from the body is often a coping mechanism for dealing with an overwhelming traumatic experience.
Individuals with a history of depression, anxiety, or posttraumatic stress disorder have higher levels of body dysmorphia, both before and after weight loss. One study found that patients undergoing bariatric surgery who had some type of psychopathology and other psychological risk factors were significantly more likely to report body image concerns 3 months after the surgery. Body image concerns were also more common in patients with preoperative depression, current psychotropic medication use, and a history of outpatient therapy or psychotropic medication use.
“Depression, anxiety, and trauma play a role in how you see yourself and how you carry yourself,” Dr. Reddy said. “This is wrapped up in any type of psychopathology. Being depressed is like looking at yourself through a cloud. It’s the opposite of ‘rose-colored glasses’ and instead, looking at yourself through a negative lens.”
Diagnosis and Interventions
Some helpful tools to assess the presence and extent of weight dissatisfaction and body dysmorphia include the Eating Disorder Inventory — Body Dissatisfaction Subscale and the Body Shape Questionnaire. It’s also important to take into account “the extent to which people are invested in their appearance psychologically,” Dr. Sarwer advised. The AO subscale of the Multidimensional Body-Self Relations Questionnaire generally assesses this. The Body Image Quality of Life Inventory assesses how and to what extent the perceived body image affects the person’s quality of life.
Experts recommend cognitive behavioral therapy (CBT) as an evidence-based intervention for body image issues, including those following weight loss.
“There’s an extensive CBT body image therapy program specifically tailored to the needs of overweight and obese individuals,” Dr. Sarwer said. “We don’t ignore historical variables that may have contributed to the problem, like early bullying, but we encourage people to think about what’s going on in their day-to-day life today. We drill down not only into the maladaptive behaviors but also the cognition and beliefs that may be erroneous but underlie these behaviors.”
The aim of CBT is to “modify irrational and dysfunctional thoughts, emotions, and behaviors through techniques such as self-monitoring, cognitive structuring, psychoeducation, desensitization, and exposure and response prevention.” The program laid out in Cash’s body image workbook includes eight steps. (Figure).
Weight Loss Doesn’t Automatically Equate With Happiness
Another realistic expectation runs counter to a common misperception that becoming thin will automatically translate into becoming happier. That’s not always the case, according to Dr. Tovar.
“If you haven’t worked deeply on addressing self-compassion and understanding that who you are at the core has nothing to do with your physical appearance, you can have an empty feeling once you’ve reached this point,” she said. “You still don’t know who you are and what you’re contributing to the world [because] you’ve been so focused on losing weight.”
Weight loss can also “unmask” questions about self-worth, even when receiving compliments about one’s “improved” appearance. “Praise and compliments after weight loss can be a double-edged sword,” Dr. Tovar observed. “You might think, ‘I wasn’t accepted or praised when I was overweight. The only way to be acceptable or validated is by losing weight, so I have to continue losing weight.’ ” This fuels fear of regaining the weight and can lead to continuing to see oneself as overweight, perhaps as a way to stay motivated to continue with weight loss. “Feeling that one’s value depends on remaining thin hampers body satisfaction,” she said.
Dr. Tovar, author of the book Deprogram Diet Culture: Rethink Your Relationship with Food, Heal Your Mind, and Live a Diet-Free Life, encourages people to shift the emphasis from weight loss to a holistic focus on self-worth and to explore obstacles to those feelings both before and after weight loss.
Endocrinologists and other medical professionals can help by not engaging in “weight and body shaming,” Dr. Tovar said.
She recommends physicians “encourage patients to tune in to their own bodies, helping them become more aware of how different foods affect their physical and emotional well-being.”
Set realistic expectations through “open, nonjudgmental conversations about the complexities of metabolism, weight, and health.”
Dr. Tovar advises rather than focusing on weight loss as the primary goal, physicians should focus on health markers such as blood glucose, energy levels, mental well-being, and physical fitness.
Prioritize “listening over lecturing.” Begin with empathy, asking questions such as “How do you feel about your health right now? What changes have you noticed in your body lately?” Doing this “creates space for the patient to express their concerns without feeling judged or shamed.”
Refer patients to a mental health professional when a patient exhibits signs of disordered eating or poor body image or when emotional factors are playing a significant role in the relationship with food and weight. “If a patient is caught in a cycle of dieting and weight gain, struggles with binge eating, or displays symptoms of depression or anxiety related to body, then psychological help is crucial.”
Ultimately, the goal of treatment “should be to provide a safe, supportive environment where patients can heal — not just physically but also emotionally and mentally,” Dr. Tovar added.
Dr. Tovar, Ms. Ekberg, and Dr. Reddy reported no relevant financial relationships. Dr. Sarwer received grant funding from the National Institute of Dental and Craniofacial Research and National Institute of Diabetes and Digestive and Kidney Diseases. He has consulting relationships with Novo Nordisk and Twenty30 Health. He is an associate editor for Obesity Surgery and editor in chief of Obesity Science & Practice.
A version of this article first appeared on Medscape.com.
Many people who lose weight, whether through diet and lifestyle changes, medication, or bariatric surgery, recognize their body has changed. While they also experience improvements in quality of life and psychosocial areas, that’s not true for everyone. Some patients don’t “see” they’ve lost weight — a phenomenon referred to as “phantom fat,” “ghost fat,” or “vestigial body image.”
“Most people are happy with their appearance, or at least their body shape, after weight loss — although some are unhappy with the loose, sagging skin that can follow weight loss and seek plastic surgery to remedy that,” David B. Sarwer, PhD, director of the Center for Obesity Research and Education and professor of social and behavioral sciences, Temple University College of Public Health, Philadelphia, told this news organization. “There’s a subset of people who remain dissatisfied with their body image, including their shape.”
This body dissatisfaction of people who lose weight may be long-standing, predating the weight loss, or may be new because weight loss has catalyzed a host of previously unaddressed psychosocial issues. Some may show up at assessments on treatment onset, while others may be detected by monitoring changes during or after weight loss. “Mental health counseling after bariatric surgery is greatly underutilized,” Dr. Sarwer observed.
Ghost Fat
Research has corroborated the lingering self-perception of being “obese” vs “ex-obese.” In one study, patients who had undergone bariatric surgery reported being unable to see the difference in their size and shape 18-30 months following their procedure, despite substantial weight loss.
Some research suggests that rapid weight loss (eg, through bariatric surgery) is more likely to generate the perception of “phantom fat,” but additional research is needed to investigate whether the mode and speed of weight loss affect subsequent body image.
Being habituated to one’s former appearance may play a role, Dr. Sarwer suggested. “We see this not only with weight loss but with other body-altering procedures. It takes the brain time to catch up to the new appearance. In rhinoplasty, for example, it may take patients a while before they become accustomed to looking at their new face in the mirror after decades of looking at a more prominent nose.”
Years of Social Stigma
It may also take time for people to overcome years of enduring the stigma of obesity.
There are “pervasive” negative attitudes implying that individuals who are overweight and/or obese are “lazy, weak-willed, lacking in self-discipline and willpower” — a problem compounded by social media and media in general, which present unrealistic, glorified body images and disparaging messages about those with weight problems.
“Body image is a construct, rather than what you see in the mirror,” Sheethal Reddy, PhD, a psychologist at the Emory Bariatric Center, Emory University Hospital Midtown, Atlanta, told this news organization. “It’s the mental construct of our physical selves.”
According to Dr. Reddy, body image develops “within a broader societal context and is influenced by the person’s ethnic, racial, and cultural heritage.”
Adolescents are particularly vulnerable to body dissatisfaction. This is compounded in those with obesity, who often experience weight-based victimization and internalized weight-based stigma, compared with adolescents with lower weights. Weight stigma often takes the form of teasing and bullying.
“Appearance-related bullying and teasing during childhood and adolescence can reverberate into adulthood and persist throughout the lifespan,” Dr. Sarwer said. “When we see these patients and ask if they’ve ever been teased or bullied, not only do many say yes but it takes them back to those moments, to that origin story, and they remember someone saying something mean, cruel, and hurtful.”
Stigmatizing experiences can affect subjective body image, even after the weight has been lost and the person’s body is objectively thinner. Research comparing individuals who were overweight and lost weight to individuals who are currently overweight and haven’t lost weight and individuals who were never overweight suggests that “vestigial” body disparagement may persist following weight loss — especially in those with early-onset obesity.
The Role of Genetics
Genetics may contribute to people’s self-perception and body dissatisfaction, both before and after weight loss. A study of 827 community-based adolescents examined the association between polygenic risk scores (PRS) for body mass index (BMI) and type 2 diabetes and symptoms of body dissatisfaction and depression.
“Given the significant genetic role in BMI, we wanted to explore whether genetic risk for BMI might also predict body dissatisfaction,” lead author Krista Ekberg, MS, a doctoral candidate in clinical psychology, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, told this news organization.
Genetic influences on BMI, as measured by PRS, were significantly associated with both phenotypic BMI and body dissatisfaction. “The association between PRS and body dissatisfaction was largely explained by BMI, suggesting that BMI itself accounts for much of the link between genetic risk and body dissatisfaction.”
Psychiatric History and Trauma
Adverse experiences, particularly sexual or physical abuse, may also account for body dissatisfaction after weight loss. “When some people with a history of this type of abuse lose a large amount of weight — typically after bariatric surgery — they often go through a period of emotional turbulence,” Dr. Sarwer said.
Childhood maltreatment can also be associated with body image disturbances in adulthood, according to a meta-analysis of 12 studies, encompassing 15,481 participants. Sexual abuse is “surprisingly common” among patients with obesity, according to Dr. Sarwer. A chart review of 131 patients revealed that 60% of those who reported a history of rape or sexual molestation were ≥ 50 pounds overweight vs only 28% of age- and sex-matched controls without a history of abuse. Other studies have corroborated these findings.
Excess weight can serve an “adaptive function,” Dr. Sarwer noted. It can be a self-protective mechanism that “insulates” them from sexual advances by potential romantic partners or abusers. Some may find that, after weight loss, repressed memories of a sexual assault surface as a result of the newer, more “attractive” appearance. Feeling vulnerable in their thinner bodies, they may need to regard themselves as overweight to maintain that feeling of “protection.” Weight loss may also trigger memories, flashbacks, or nightmares, as people return to a weight at which they were abused.
Dissociation is another mechanism linking trauma with post–weight loss body dysmorphia, Supatra Tovar, PsyD, RD, a clinical psychologist and registered dietitian with a practice in California, told this news organization. Dissociation from the body is often a coping mechanism for dealing with an overwhelming traumatic experience.
Individuals with a history of depression, anxiety, or posttraumatic stress disorder have higher levels of body dysmorphia, both before and after weight loss. One study found that patients undergoing bariatric surgery who had some type of psychopathology and other psychological risk factors were significantly more likely to report body image concerns 3 months after the surgery. Body image concerns were also more common in patients with preoperative depression, current psychotropic medication use, and a history of outpatient therapy or psychotropic medication use.
“Depression, anxiety, and trauma play a role in how you see yourself and how you carry yourself,” Dr. Reddy said. “This is wrapped up in any type of psychopathology. Being depressed is like looking at yourself through a cloud. It’s the opposite of ‘rose-colored glasses’ and instead, looking at yourself through a negative lens.”
Diagnosis and Interventions
Some helpful tools to assess the presence and extent of weight dissatisfaction and body dysmorphia include the Eating Disorder Inventory — Body Dissatisfaction Subscale and the Body Shape Questionnaire. It’s also important to take into account “the extent to which people are invested in their appearance psychologically,” Dr. Sarwer advised. The AO subscale of the Multidimensional Body-Self Relations Questionnaire generally assesses this. The Body Image Quality of Life Inventory assesses how and to what extent the perceived body image affects the person’s quality of life.
Experts recommend cognitive behavioral therapy (CBT) as an evidence-based intervention for body image issues, including those following weight loss.
“There’s an extensive CBT body image therapy program specifically tailored to the needs of overweight and obese individuals,” Dr. Sarwer said. “We don’t ignore historical variables that may have contributed to the problem, like early bullying, but we encourage people to think about what’s going on in their day-to-day life today. We drill down not only into the maladaptive behaviors but also the cognition and beliefs that may be erroneous but underlie these behaviors.”
The aim of CBT is to “modify irrational and dysfunctional thoughts, emotions, and behaviors through techniques such as self-monitoring, cognitive structuring, psychoeducation, desensitization, and exposure and response prevention.” The program laid out in Cash’s body image workbook includes eight steps. (Figure).
Weight Loss Doesn’t Automatically Equate With Happiness
Another realistic expectation runs counter to a common misperception that becoming thin will automatically translate into becoming happier. That’s not always the case, according to Dr. Tovar.
“If you haven’t worked deeply on addressing self-compassion and understanding that who you are at the core has nothing to do with your physical appearance, you can have an empty feeling once you’ve reached this point,” she said. “You still don’t know who you are and what you’re contributing to the world [because] you’ve been so focused on losing weight.”
Weight loss can also “unmask” questions about self-worth, even when receiving compliments about one’s “improved” appearance. “Praise and compliments after weight loss can be a double-edged sword,” Dr. Tovar observed. “You might think, ‘I wasn’t accepted or praised when I was overweight. The only way to be acceptable or validated is by losing weight, so I have to continue losing weight.’ ” This fuels fear of regaining the weight and can lead to continuing to see oneself as overweight, perhaps as a way to stay motivated to continue with weight loss. “Feeling that one’s value depends on remaining thin hampers body satisfaction,” she said.
Dr. Tovar, author of the book Deprogram Diet Culture: Rethink Your Relationship with Food, Heal Your Mind, and Live a Diet-Free Life, encourages people to shift the emphasis from weight loss to a holistic focus on self-worth and to explore obstacles to those feelings both before and after weight loss.
Endocrinologists and other medical professionals can help by not engaging in “weight and body shaming,” Dr. Tovar said.
She recommends physicians “encourage patients to tune in to their own bodies, helping them become more aware of how different foods affect their physical and emotional well-being.”
Set realistic expectations through “open, nonjudgmental conversations about the complexities of metabolism, weight, and health.”
Dr. Tovar advises rather than focusing on weight loss as the primary goal, physicians should focus on health markers such as blood glucose, energy levels, mental well-being, and physical fitness.
Prioritize “listening over lecturing.” Begin with empathy, asking questions such as “How do you feel about your health right now? What changes have you noticed in your body lately?” Doing this “creates space for the patient to express their concerns without feeling judged or shamed.”
Refer patients to a mental health professional when a patient exhibits signs of disordered eating or poor body image or when emotional factors are playing a significant role in the relationship with food and weight. “If a patient is caught in a cycle of dieting and weight gain, struggles with binge eating, or displays symptoms of depression or anxiety related to body, then psychological help is crucial.”
Ultimately, the goal of treatment “should be to provide a safe, supportive environment where patients can heal — not just physically but also emotionally and mentally,” Dr. Tovar added.
Dr. Tovar, Ms. Ekberg, and Dr. Reddy reported no relevant financial relationships. Dr. Sarwer received grant funding from the National Institute of Dental and Craniofacial Research and National Institute of Diabetes and Digestive and Kidney Diseases. He has consulting relationships with Novo Nordisk and Twenty30 Health. He is an associate editor for Obesity Surgery and editor in chief of Obesity Science & Practice.
A version of this article first appeared on Medscape.com.
Many people who lose weight, whether through diet and lifestyle changes, medication, or bariatric surgery, recognize their body has changed. While they also experience improvements in quality of life and psychosocial areas, that’s not true for everyone. Some patients don’t “see” they’ve lost weight — a phenomenon referred to as “phantom fat,” “ghost fat,” or “vestigial body image.”
“Most people are happy with their appearance, or at least their body shape, after weight loss — although some are unhappy with the loose, sagging skin that can follow weight loss and seek plastic surgery to remedy that,” David B. Sarwer, PhD, director of the Center for Obesity Research and Education and professor of social and behavioral sciences, Temple University College of Public Health, Philadelphia, told this news organization. “There’s a subset of people who remain dissatisfied with their body image, including their shape.”
This body dissatisfaction of people who lose weight may be long-standing, predating the weight loss, or may be new because weight loss has catalyzed a host of previously unaddressed psychosocial issues. Some may show up at assessments on treatment onset, while others may be detected by monitoring changes during or after weight loss. “Mental health counseling after bariatric surgery is greatly underutilized,” Dr. Sarwer observed.
Ghost Fat
Research has corroborated the lingering self-perception of being “obese” vs “ex-obese.” In one study, patients who had undergone bariatric surgery reported being unable to see the difference in their size and shape 18-30 months following their procedure, despite substantial weight loss.
Some research suggests that rapid weight loss (eg, through bariatric surgery) is more likely to generate the perception of “phantom fat,” but additional research is needed to investigate whether the mode and speed of weight loss affect subsequent body image.
Being habituated to one’s former appearance may play a role, Dr. Sarwer suggested. “We see this not only with weight loss but with other body-altering procedures. It takes the brain time to catch up to the new appearance. In rhinoplasty, for example, it may take patients a while before they become accustomed to looking at their new face in the mirror after decades of looking at a more prominent nose.”
Years of Social Stigma
It may also take time for people to overcome years of enduring the stigma of obesity.
There are “pervasive” negative attitudes implying that individuals who are overweight and/or obese are “lazy, weak-willed, lacking in self-discipline and willpower” — a problem compounded by social media and media in general, which present unrealistic, glorified body images and disparaging messages about those with weight problems.
“Body image is a construct, rather than what you see in the mirror,” Sheethal Reddy, PhD, a psychologist at the Emory Bariatric Center, Emory University Hospital Midtown, Atlanta, told this news organization. “It’s the mental construct of our physical selves.”
According to Dr. Reddy, body image develops “within a broader societal context and is influenced by the person’s ethnic, racial, and cultural heritage.”
Adolescents are particularly vulnerable to body dissatisfaction. This is compounded in those with obesity, who often experience weight-based victimization and internalized weight-based stigma, compared with adolescents with lower weights. Weight stigma often takes the form of teasing and bullying.
“Appearance-related bullying and teasing during childhood and adolescence can reverberate into adulthood and persist throughout the lifespan,” Dr. Sarwer said. “When we see these patients and ask if they’ve ever been teased or bullied, not only do many say yes but it takes them back to those moments, to that origin story, and they remember someone saying something mean, cruel, and hurtful.”
Stigmatizing experiences can affect subjective body image, even after the weight has been lost and the person’s body is objectively thinner. Research comparing individuals who were overweight and lost weight to individuals who are currently overweight and haven’t lost weight and individuals who were never overweight suggests that “vestigial” body disparagement may persist following weight loss — especially in those with early-onset obesity.
The Role of Genetics
Genetics may contribute to people’s self-perception and body dissatisfaction, both before and after weight loss. A study of 827 community-based adolescents examined the association between polygenic risk scores (PRS) for body mass index (BMI) and type 2 diabetes and symptoms of body dissatisfaction and depression.
“Given the significant genetic role in BMI, we wanted to explore whether genetic risk for BMI might also predict body dissatisfaction,” lead author Krista Ekberg, MS, a doctoral candidate in clinical psychology, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, told this news organization.
Genetic influences on BMI, as measured by PRS, were significantly associated with both phenotypic BMI and body dissatisfaction. “The association between PRS and body dissatisfaction was largely explained by BMI, suggesting that BMI itself accounts for much of the link between genetic risk and body dissatisfaction.”
Psychiatric History and Trauma
Adverse experiences, particularly sexual or physical abuse, may also account for body dissatisfaction after weight loss. “When some people with a history of this type of abuse lose a large amount of weight — typically after bariatric surgery — they often go through a period of emotional turbulence,” Dr. Sarwer said.
Childhood maltreatment can also be associated with body image disturbances in adulthood, according to a meta-analysis of 12 studies, encompassing 15,481 participants. Sexual abuse is “surprisingly common” among patients with obesity, according to Dr. Sarwer. A chart review of 131 patients revealed that 60% of those who reported a history of rape or sexual molestation were ≥ 50 pounds overweight vs only 28% of age- and sex-matched controls without a history of abuse. Other studies have corroborated these findings.
Excess weight can serve an “adaptive function,” Dr. Sarwer noted. It can be a self-protective mechanism that “insulates” them from sexual advances by potential romantic partners or abusers. Some may find that, after weight loss, repressed memories of a sexual assault surface as a result of the newer, more “attractive” appearance. Feeling vulnerable in their thinner bodies, they may need to regard themselves as overweight to maintain that feeling of “protection.” Weight loss may also trigger memories, flashbacks, or nightmares, as people return to a weight at which they were abused.
Dissociation is another mechanism linking trauma with post–weight loss body dysmorphia, Supatra Tovar, PsyD, RD, a clinical psychologist and registered dietitian with a practice in California, told this news organization. Dissociation from the body is often a coping mechanism for dealing with an overwhelming traumatic experience.
Individuals with a history of depression, anxiety, or posttraumatic stress disorder have higher levels of body dysmorphia, both before and after weight loss. One study found that patients undergoing bariatric surgery who had some type of psychopathology and other psychological risk factors were significantly more likely to report body image concerns 3 months after the surgery. Body image concerns were also more common in patients with preoperative depression, current psychotropic medication use, and a history of outpatient therapy or psychotropic medication use.
“Depression, anxiety, and trauma play a role in how you see yourself and how you carry yourself,” Dr. Reddy said. “This is wrapped up in any type of psychopathology. Being depressed is like looking at yourself through a cloud. It’s the opposite of ‘rose-colored glasses’ and instead, looking at yourself through a negative lens.”
Diagnosis and Interventions
Some helpful tools to assess the presence and extent of weight dissatisfaction and body dysmorphia include the Eating Disorder Inventory — Body Dissatisfaction Subscale and the Body Shape Questionnaire. It’s also important to take into account “the extent to which people are invested in their appearance psychologically,” Dr. Sarwer advised. The AO subscale of the Multidimensional Body-Self Relations Questionnaire generally assesses this. The Body Image Quality of Life Inventory assesses how and to what extent the perceived body image affects the person’s quality of life.
Experts recommend cognitive behavioral therapy (CBT) as an evidence-based intervention for body image issues, including those following weight loss.
“There’s an extensive CBT body image therapy program specifically tailored to the needs of overweight and obese individuals,” Dr. Sarwer said. “We don’t ignore historical variables that may have contributed to the problem, like early bullying, but we encourage people to think about what’s going on in their day-to-day life today. We drill down not only into the maladaptive behaviors but also the cognition and beliefs that may be erroneous but underlie these behaviors.”
The aim of CBT is to “modify irrational and dysfunctional thoughts, emotions, and behaviors through techniques such as self-monitoring, cognitive structuring, psychoeducation, desensitization, and exposure and response prevention.” The program laid out in Cash’s body image workbook includes eight steps. (Figure).
Weight Loss Doesn’t Automatically Equate With Happiness
Another realistic expectation runs counter to a common misperception that becoming thin will automatically translate into becoming happier. That’s not always the case, according to Dr. Tovar.
“If you haven’t worked deeply on addressing self-compassion and understanding that who you are at the core has nothing to do with your physical appearance, you can have an empty feeling once you’ve reached this point,” she said. “You still don’t know who you are and what you’re contributing to the world [because] you’ve been so focused on losing weight.”
Weight loss can also “unmask” questions about self-worth, even when receiving compliments about one’s “improved” appearance. “Praise and compliments after weight loss can be a double-edged sword,” Dr. Tovar observed. “You might think, ‘I wasn’t accepted or praised when I was overweight. The only way to be acceptable or validated is by losing weight, so I have to continue losing weight.’ ” This fuels fear of regaining the weight and can lead to continuing to see oneself as overweight, perhaps as a way to stay motivated to continue with weight loss. “Feeling that one’s value depends on remaining thin hampers body satisfaction,” she said.
Dr. Tovar, author of the book Deprogram Diet Culture: Rethink Your Relationship with Food, Heal Your Mind, and Live a Diet-Free Life, encourages people to shift the emphasis from weight loss to a holistic focus on self-worth and to explore obstacles to those feelings both before and after weight loss.
Endocrinologists and other medical professionals can help by not engaging in “weight and body shaming,” Dr. Tovar said.
She recommends physicians “encourage patients to tune in to their own bodies, helping them become more aware of how different foods affect their physical and emotional well-being.”
Set realistic expectations through “open, nonjudgmental conversations about the complexities of metabolism, weight, and health.”
Dr. Tovar advises rather than focusing on weight loss as the primary goal, physicians should focus on health markers such as blood glucose, energy levels, mental well-being, and physical fitness.
Prioritize “listening over lecturing.” Begin with empathy, asking questions such as “How do you feel about your health right now? What changes have you noticed in your body lately?” Doing this “creates space for the patient to express their concerns without feeling judged or shamed.”
Refer patients to a mental health professional when a patient exhibits signs of disordered eating or poor body image or when emotional factors are playing a significant role in the relationship with food and weight. “If a patient is caught in a cycle of dieting and weight gain, struggles with binge eating, or displays symptoms of depression or anxiety related to body, then psychological help is crucial.”
Ultimately, the goal of treatment “should be to provide a safe, supportive environment where patients can heal — not just physically but also emotionally and mentally,” Dr. Tovar added.
Dr. Tovar, Ms. Ekberg, and Dr. Reddy reported no relevant financial relationships. Dr. Sarwer received grant funding from the National Institute of Dental and Craniofacial Research and National Institute of Diabetes and Digestive and Kidney Diseases. He has consulting relationships with Novo Nordisk and Twenty30 Health. He is an associate editor for Obesity Surgery and editor in chief of Obesity Science & Practice.
A version of this article first appeared on Medscape.com.