Depression

PARIS – A single 25-mg dose of a synthetic formulation of psilocybin appears to improve the core symptoms of treatment-resistant depression (TRD), a new analysis of phase 2 trial data suggests.

Known as COMP360, the synthetic agent, a proprietary, purified form of psilocybin, improved symptoms related to mood and anhedonia while leaving aspects such as appetite and weight changes unaffected, reported investigators led by Guy M. Goodwin, PhD, emeritus professor of psychiatry, University of Oxford, England, and chief medical officer, COMPASS Pathways.

The study was presented at the European Psychiatric Association (EPA) 2023 Congress.
 

100 million affected

Affecting up to 100 million people globally, TRD is “not an official diagnosis,” although it is often defined as the failure to elicit a response with at least two antidepressant treatments, said Dr. Goodwin.

Compared to their counterparts with non-TRD, those with TRD experience higher relapse rates, higher rates of suicidal behavior, and more residual symptoms even when they do respond to treatment.

Previous results from the study known as P-TRD indicated that a single 25-mg dose of COMP360 significantly reduced depression scores for up to 12 weeks when given along with psychological support, although a later analysis suggested the effect subsequently dropped off.

The vast majority of the patients in the trial were naive to psychedelics, and so, Dr. Goodwin explained, they undergo a preparation phase during which they receive psychoeducation and have at least two visits with a therapist, who then stays with them during administration of the drug to offer support if they experience psychological distress.

Following the psilocybin session, participants go through a process known as integration, which involves two sessions with a therapist within 2 weeks.

“That, in our view, is essentially about safety, and about identifying problems that have arisen as a result of taking the drug,” said Dr. Goodwin.

The phase 2b trial examined changes in specific depression symptoms after psilocybin treatment in 233 patients with TRD. Participants were a mean age of 39.8 years and 59% were women. They were randomized to receive one of three doses of the drug: a 1-mg dose (n = 79), a 10-mg dose (n = 75), or a 25-mg dose (n = 79).

The primary outcome was changes in individual items on the Montgomery-Åsberg Depression Rating Scale (MADRS) and 16-item Quick Inventory of Depressive Symptomatology–Self Report (QIDS-SR-16) scale.

While the effect on overall depression scores is important, said Dr. Goodwin, many of the items included in the depression assessment scales are “uninformative.”
 

Reduction in ‘core’ symptoms

Participants were assessed by a blinded rater at baseline, day 1, day 2, and at 1, 2, 3, 6, 9, and 12 weeks after administration of COMP360. The primary endpoint was a reduction in individual items on MADRS and scores from baseline to 3 weeks. Individual items on the QIDS-SR-16 were rated by participants at the same time points.

Investigators found the largest mean changes from baseline were on reported and apparent sadness, lassitude, inability to feel, and concentration difficulties, with “very nice and clear dose-related differences,” Dr. Goodwin said.

The results indicate that the significant benefit with the largest dose at 3 weeks versus baseline was confined to items such as inability to feel and reported and apparent sadness on the MADRS and feeling sad and general interest on the QIDS-SR-16 (Table 1).

The results suggest the effect of COMP360 is “on the core symptoms of depression,” said Dr. Goodwin.

Enthusiasm running ahead of the data

Commenting on the findings, Bertha K. Madras, PhD, professor of psychobiology, department of psychiatry, Harvard Medical School, Boston, who was not involved in the study, said “hallucinogens are an intriguing class of drugs and I support ongoing high-quality research in this area.”

However, she told this news organization that the “breathtaking endorsement of this drug is far ahead of scientific data.”

She cited concerns such as the “narrow demographics” of participants, their previous experience with and expectations of hallucinogens, the “potential for symptom fluidity of enrollees,” such as depression evolving into psychosis, and the “undefined role” of the therapist during a hallucinogenic session.

“Finally, I am concerned that enthusiasm for therapeutic potential has been, and will continue to be, preempted and directed towards legalization and widespread access for vulnerable populations,” Dr. Madras said.

This, she said, “is occurring at breakneck speed in the U.S., with scant resistance or skepticism from the investigators engaged in therapeutic assessment.”

The study was funded by COMPASS Pathways. Dr. Goodwin has reported relationships with COMPASS Pathways, Buckley Psytech, Boehringer Ingelheim, Clerkenwell Health, EVA Pharma, Lundbeck, Janssen Global Services, Novartis, Ocean Neurosciences, P1vital, Sage Therapeutics, Servier, Takeda, and WebMD.
 

A version of this article first appeared on Medscape.com.

PARIS – A single 25-mg dose of a synthetic formulation of psilocybin appears to improve the core symptoms of treatment-resistant depression (TRD), a new analysis of phase 2 trial data suggests.

Known as COMP360, the synthetic agent, a proprietary, purified form of psilocybin, improved symptoms related to mood and anhedonia while leaving aspects such as appetite and weight changes unaffected, reported investigators led by Guy M. Goodwin, PhD, emeritus professor of psychiatry, University of Oxford, England, and chief medical officer, COMPASS Pathways.

The study was presented at the European Psychiatric Association (EPA) 2023 Congress.
 

100 million affected

Affecting up to 100 million people globally, TRD is “not an official diagnosis,” although it is often defined as the failure to elicit a response with at least two antidepressant treatments, said Dr. Goodwin.

Compared to their counterparts with non-TRD, those with TRD experience higher relapse rates, higher rates of suicidal behavior, and more residual symptoms even when they do respond to treatment.

Previous results from the study known as P-TRD indicated that a single 25-mg dose of COMP360 significantly reduced depression scores for up to 12 weeks when given along with psychological support, although a later analysis suggested the effect subsequently dropped off.

The vast majority of the patients in the trial were naive to psychedelics, and so, Dr. Goodwin explained, they undergo a preparation phase during which they receive psychoeducation and have at least two visits with a therapist, who then stays with them during administration of the drug to offer support if they experience psychological distress.

Following the psilocybin session, participants go through a process known as integration, which involves two sessions with a therapist within 2 weeks.

“That, in our view, is essentially about safety, and about identifying problems that have arisen as a result of taking the drug,” said Dr. Goodwin.

The phase 2b trial examined changes in specific depression symptoms after psilocybin treatment in 233 patients with TRD. Participants were a mean age of 39.8 years and 59% were women. They were randomized to receive one of three doses of the drug: a 1-mg dose (n = 79), a 10-mg dose (n = 75), or a 25-mg dose (n = 79).

The primary outcome was changes in individual items on the Montgomery-Åsberg Depression Rating Scale (MADRS) and 16-item Quick Inventory of Depressive Symptomatology–Self Report (QIDS-SR-16) scale.

While the effect on overall depression scores is important, said Dr. Goodwin, many of the items included in the depression assessment scales are “uninformative.”
 

Reduction in ‘core’ symptoms

Participants were assessed by a blinded rater at baseline, day 1, day 2, and at 1, 2, 3, 6, 9, and 12 weeks after administration of COMP360. The primary endpoint was a reduction in individual items on MADRS and scores from baseline to 3 weeks. Individual items on the QIDS-SR-16 were rated by participants at the same time points.

Investigators found the largest mean changes from baseline were on reported and apparent sadness, lassitude, inability to feel, and concentration difficulties, with “very nice and clear dose-related differences,” Dr. Goodwin said.

The results indicate that the significant benefit with the largest dose at 3 weeks versus baseline was confined to items such as inability to feel and reported and apparent sadness on the MADRS and feeling sad and general interest on the QIDS-SR-16 (Table 1).

The results suggest the effect of COMP360 is “on the core symptoms of depression,” said Dr. Goodwin.

Enthusiasm running ahead of the data

Commenting on the findings, Bertha K. Madras, PhD, professor of psychobiology, department of psychiatry, Harvard Medical School, Boston, who was not involved in the study, said “hallucinogens are an intriguing class of drugs and I support ongoing high-quality research in this area.”

However, she told this news organization that the “breathtaking endorsement of this drug is far ahead of scientific data.”

She cited concerns such as the “narrow demographics” of participants, their previous experience with and expectations of hallucinogens, the “potential for symptom fluidity of enrollees,” such as depression evolving into psychosis, and the “undefined role” of the therapist during a hallucinogenic session.

“Finally, I am concerned that enthusiasm for therapeutic potential has been, and will continue to be, preempted and directed towards legalization and widespread access for vulnerable populations,” Dr. Madras said.

This, she said, “is occurring at breakneck speed in the U.S., with scant resistance or skepticism from the investigators engaged in therapeutic assessment.”

The study was funded by COMPASS Pathways. Dr. Goodwin has reported relationships with COMPASS Pathways, Buckley Psytech, Boehringer Ingelheim, Clerkenwell Health, EVA Pharma, Lundbeck, Janssen Global Services, Novartis, Ocean Neurosciences, P1vital, Sage Therapeutics, Servier, Takeda, and WebMD.
 

A version of this article first appeared on Medscape.com.

PARIS – A single 25-mg dose of a synthetic formulation of psilocybin appears to improve the core symptoms of treatment-resistant depression (TRD), a new analysis of phase 2 trial data suggests.

Known as COMP360, the synthetic agent, a proprietary, purified form of psilocybin, improved symptoms related to mood and anhedonia while leaving aspects such as appetite and weight changes unaffected, reported investigators led by Guy M. Goodwin, PhD, emeritus professor of psychiatry, University of Oxford, England, and chief medical officer, COMPASS Pathways.

The study was presented at the European Psychiatric Association (EPA) 2023 Congress.
 

100 million affected

Affecting up to 100 million people globally, TRD is “not an official diagnosis,” although it is often defined as the failure to elicit a response with at least two antidepressant treatments, said Dr. Goodwin.

Compared to their counterparts with non-TRD, those with TRD experience higher relapse rates, higher rates of suicidal behavior, and more residual symptoms even when they do respond to treatment.

Previous results from the study known as P-TRD indicated that a single 25-mg dose of COMP360 significantly reduced depression scores for up to 12 weeks when given along with psychological support, although a later analysis suggested the effect subsequently dropped off.

The vast majority of the patients in the trial were naive to psychedelics, and so, Dr. Goodwin explained, they undergo a preparation phase during which they receive psychoeducation and have at least two visits with a therapist, who then stays with them during administration of the drug to offer support if they experience psychological distress.

Following the psilocybin session, participants go through a process known as integration, which involves two sessions with a therapist within 2 weeks.

“That, in our view, is essentially about safety, and about identifying problems that have arisen as a result of taking the drug,” said Dr. Goodwin.

The phase 2b trial examined changes in specific depression symptoms after psilocybin treatment in 233 patients with TRD. Participants were a mean age of 39.8 years and 59% were women. They were randomized to receive one of three doses of the drug: a 1-mg dose (n = 79), a 10-mg dose (n = 75), or a 25-mg dose (n = 79).

The primary outcome was changes in individual items on the Montgomery-Åsberg Depression Rating Scale (MADRS) and 16-item Quick Inventory of Depressive Symptomatology–Self Report (QIDS-SR-16) scale.

While the effect on overall depression scores is important, said Dr. Goodwin, many of the items included in the depression assessment scales are “uninformative.”
 

Reduction in ‘core’ symptoms

Participants were assessed by a blinded rater at baseline, day 1, day 2, and at 1, 2, 3, 6, 9, and 12 weeks after administration of COMP360. The primary endpoint was a reduction in individual items on MADRS and scores from baseline to 3 weeks. Individual items on the QIDS-SR-16 were rated by participants at the same time points.

Investigators found the largest mean changes from baseline were on reported and apparent sadness, lassitude, inability to feel, and concentration difficulties, with “very nice and clear dose-related differences,” Dr. Goodwin said.

The results indicate that the significant benefit with the largest dose at 3 weeks versus baseline was confined to items such as inability to feel and reported and apparent sadness on the MADRS and feeling sad and general interest on the QIDS-SR-16 (Table 1).

The results suggest the effect of COMP360 is “on the core symptoms of depression,” said Dr. Goodwin.

Enthusiasm running ahead of the data

Commenting on the findings, Bertha K. Madras, PhD, professor of psychobiology, department of psychiatry, Harvard Medical School, Boston, who was not involved in the study, said “hallucinogens are an intriguing class of drugs and I support ongoing high-quality research in this area.”

However, she told this news organization that the “breathtaking endorsement of this drug is far ahead of scientific data.”

She cited concerns such as the “narrow demographics” of participants, their previous experience with and expectations of hallucinogens, the “potential for symptom fluidity of enrollees,” such as depression evolving into psychosis, and the “undefined role” of the therapist during a hallucinogenic session.

“Finally, I am concerned that enthusiasm for therapeutic potential has been, and will continue to be, preempted and directed towards legalization and widespread access for vulnerable populations,” Dr. Madras said.

This, she said, “is occurring at breakneck speed in the U.S., with scant resistance or skepticism from the investigators engaged in therapeutic assessment.”

The study was funded by COMPASS Pathways. Dr. Goodwin has reported relationships with COMPASS Pathways, Buckley Psytech, Boehringer Ingelheim, Clerkenwell Health, EVA Pharma, Lundbeck, Janssen Global Services, Novartis, Ocean Neurosciences, P1vital, Sage Therapeutics, Servier, Takeda, and WebMD.
 

A version of this article first appeared on Medscape.com.

Approximately 10,000 suicide deaths are recorded in Brazil every year. The suicide risk is highest among patients with depressive disorders, particularly women (> 18% vs. 11% for men).

There are countless people who work to prevent suicide, and the challenges they face are many. But now, on the horizon, there are new tools that could prove invaluable to their efforts – tools such as biomarkers. In a study recently published in the journal Frontiers in Psychiatry, researchers from the Catholic University of Pelotas (UCPel), Brazil, reported an association of glutathione (GSH) with the degree of suicide risk in women at 18 months postpartum. Specifically, they found that reduced serum GSH levels were significantly lower for those with moderate to high suicide risk than for those without suicide risk. Their findings suggest that GSH may be a potential biomarker or etiologic factor among women at risk for suicide, with therapeutic implications.

This was a case-control study nested within a cohort study. From this cohort, 45 women were selected at 18 months postpartum. Thirty of them had mood disorders, such as major depression and bipolar disorder. The other 15 participants, none of whom had a mood disorder, made up the control group.

Depression and the risk for suicide were assessed using the Mini International Neuropsychiatric Interview Plus (MINI-Plus 5.0.0 Brazilian version), module A and module C, respectively. Blood samples were collected to evaluate serum levels of the following oxidative stress biomarkers: reactive oxygen species, superoxide dismutase, and GSH.

The prevalence of suicide risk observed in the women at 18 months postpartum was 24.4%. The prevalence of suicide risk in the mood disorder group was 36.7%.

In addition, the statistical analysis found that women with moderate to high suicide risk had cerebral redox imbalance, resulting in a decrease in blood GSH levels.

The study team was led by neuroscientist Adriano Martimbianco de Assis, PhD, the coordinator of UCPel’s postgraduate program in health and behavior. He said that the correlation identified between GSH serum levels and suicide risk gives rise to two possible applications: using GSH as a biomarker for suicide risk and using GSH therapeutically.

Regarding the former application, Dr. Martimbianco de Assis explained that additional studies are needed to take a step forward. “Although we believe that most of the GSH came from the brain – given that it’s the brain’s main antioxidant – as we analyze blood samples, we’re not yet able to rule out the possibility that it came from other organs,” he said in an interview. So, confirming that hypothesis will require studies that involve imaging brain tissue. According to Dr. Martimbianco de Assis, once there is confirmation, it will be possible to move to using the antioxidant as a biomarker for suicide risk.

He also shared his views about the second application: using GSH therapeutically. “We already know that there are very simple alternatives that can influence GSH levels, [and they] mostly have to do with exercise and [improving the quality of] the food one eats. But there are also drugs: for example, N-acetyl cysteine, which is a precursor of GSH.” Adopting strategies to increase the levels of this antioxidant in the body should reverse the imbalance identified in the study and, as a result, may lead to lowering the risk for suicide. But, he reiterated, “getting to a place where GSH [can be used] in clinical practice hinges on getting that confirmation that it did, in fact, come from the brain. Recall that our study found lower levels of GSH in women at risk for suicide.”

Even though the study evaluated postpartum women, it’s possible that the results can be extrapolated to other populations, said Dr. Martimbianco de Assis. This is because when the data were collected, 18 months had already passed since giving birth. The participants’ physiological condition at that point was more similar to the one prior to becoming pregnant.

The UCPel researchers continue to follow the cohort. “We intend to continue monitoring GSH levels at other times. Forty-eight months have now passed since the women gave birth, and the idea is to continue studying [the patients involved in the study],” said Dr. Martimbianco de Assis, adding that the team also intends to analyze brain tissue from in vitro studies using cell cultures.

This article was translated from the Medscape Portuguese Edition and a version appeared on Medscape.com.

Approximately 10,000 suicide deaths are recorded in Brazil every year. The suicide risk is highest among patients with depressive disorders, particularly women (> 18% vs. 11% for men).

There are countless people who work to prevent suicide, and the challenges they face are many. But now, on the horizon, there are new tools that could prove invaluable to their efforts – tools such as biomarkers. In a study recently published in the journal Frontiers in Psychiatry, researchers from the Catholic University of Pelotas (UCPel), Brazil, reported an association of glutathione (GSH) with the degree of suicide risk in women at 18 months postpartum. Specifically, they found that reduced serum GSH levels were significantly lower for those with moderate to high suicide risk than for those without suicide risk. Their findings suggest that GSH may be a potential biomarker or etiologic factor among women at risk for suicide, with therapeutic implications.

This was a case-control study nested within a cohort study. From this cohort, 45 women were selected at 18 months postpartum. Thirty of them had mood disorders, such as major depression and bipolar disorder. The other 15 participants, none of whom had a mood disorder, made up the control group.

Depression and the risk for suicide were assessed using the Mini International Neuropsychiatric Interview Plus (MINI-Plus 5.0.0 Brazilian version), module A and module C, respectively. Blood samples were collected to evaluate serum levels of the following oxidative stress biomarkers: reactive oxygen species, superoxide dismutase, and GSH.

The prevalence of suicide risk observed in the women at 18 months postpartum was 24.4%. The prevalence of suicide risk in the mood disorder group was 36.7%.

In addition, the statistical analysis found that women with moderate to high suicide risk had cerebral redox imbalance, resulting in a decrease in blood GSH levels.

The study team was led by neuroscientist Adriano Martimbianco de Assis, PhD, the coordinator of UCPel’s postgraduate program in health and behavior. He said that the correlation identified between GSH serum levels and suicide risk gives rise to two possible applications: using GSH as a biomarker for suicide risk and using GSH therapeutically.

Regarding the former application, Dr. Martimbianco de Assis explained that additional studies are needed to take a step forward. “Although we believe that most of the GSH came from the brain – given that it’s the brain’s main antioxidant – as we analyze blood samples, we’re not yet able to rule out the possibility that it came from other organs,” he said in an interview. So, confirming that hypothesis will require studies that involve imaging brain tissue. According to Dr. Martimbianco de Assis, once there is confirmation, it will be possible to move to using the antioxidant as a biomarker for suicide risk.

He also shared his views about the second application: using GSH therapeutically. “We already know that there are very simple alternatives that can influence GSH levels, [and they] mostly have to do with exercise and [improving the quality of] the food one eats. But there are also drugs: for example, N-acetyl cysteine, which is a precursor of GSH.” Adopting strategies to increase the levels of this antioxidant in the body should reverse the imbalance identified in the study and, as a result, may lead to lowering the risk for suicide. But, he reiterated, “getting to a place where GSH [can be used] in clinical practice hinges on getting that confirmation that it did, in fact, come from the brain. Recall that our study found lower levels of GSH in women at risk for suicide.”

Even though the study evaluated postpartum women, it’s possible that the results can be extrapolated to other populations, said Dr. Martimbianco de Assis. This is because when the data were collected, 18 months had already passed since giving birth. The participants’ physiological condition at that point was more similar to the one prior to becoming pregnant.

The UCPel researchers continue to follow the cohort. “We intend to continue monitoring GSH levels at other times. Forty-eight months have now passed since the women gave birth, and the idea is to continue studying [the patients involved in the study],” said Dr. Martimbianco de Assis, adding that the team also intends to analyze brain tissue from in vitro studies using cell cultures.

This article was translated from the Medscape Portuguese Edition and a version appeared on Medscape.com.

Approximately 10,000 suicide deaths are recorded in Brazil every year. The suicide risk is highest among patients with depressive disorders, particularly women (> 18% vs. 11% for men).

There are countless people who work to prevent suicide, and the challenges they face are many. But now, on the horizon, there are new tools that could prove invaluable to their efforts – tools such as biomarkers. In a study recently published in the journal Frontiers in Psychiatry, researchers from the Catholic University of Pelotas (UCPel), Brazil, reported an association of glutathione (GSH) with the degree of suicide risk in women at 18 months postpartum. Specifically, they found that reduced serum GSH levels were significantly lower for those with moderate to high suicide risk than for those without suicide risk. Their findings suggest that GSH may be a potential biomarker or etiologic factor among women at risk for suicide, with therapeutic implications.

This was a case-control study nested within a cohort study. From this cohort, 45 women were selected at 18 months postpartum. Thirty of them had mood disorders, such as major depression and bipolar disorder. The other 15 participants, none of whom had a mood disorder, made up the control group.

Depression and the risk for suicide were assessed using the Mini International Neuropsychiatric Interview Plus (MINI-Plus 5.0.0 Brazilian version), module A and module C, respectively. Blood samples were collected to evaluate serum levels of the following oxidative stress biomarkers: reactive oxygen species, superoxide dismutase, and GSH.

The prevalence of suicide risk observed in the women at 18 months postpartum was 24.4%. The prevalence of suicide risk in the mood disorder group was 36.7%.

In addition, the statistical analysis found that women with moderate to high suicide risk had cerebral redox imbalance, resulting in a decrease in blood GSH levels.

The study team was led by neuroscientist Adriano Martimbianco de Assis, PhD, the coordinator of UCPel’s postgraduate program in health and behavior. He said that the correlation identified between GSH serum levels and suicide risk gives rise to two possible applications: using GSH as a biomarker for suicide risk and using GSH therapeutically.

Regarding the former application, Dr. Martimbianco de Assis explained that additional studies are needed to take a step forward. “Although we believe that most of the GSH came from the brain – given that it’s the brain’s main antioxidant – as we analyze blood samples, we’re not yet able to rule out the possibility that it came from other organs,” he said in an interview. So, confirming that hypothesis will require studies that involve imaging brain tissue. According to Dr. Martimbianco de Assis, once there is confirmation, it will be possible to move to using the antioxidant as a biomarker for suicide risk.

He also shared his views about the second application: using GSH therapeutically. “We already know that there are very simple alternatives that can influence GSH levels, [and they] mostly have to do with exercise and [improving the quality of] the food one eats. But there are also drugs: for example, N-acetyl cysteine, which is a precursor of GSH.” Adopting strategies to increase the levels of this antioxidant in the body should reverse the imbalance identified in the study and, as a result, may lead to lowering the risk for suicide. But, he reiterated, “getting to a place where GSH [can be used] in clinical practice hinges on getting that confirmation that it did, in fact, come from the brain. Recall that our study found lower levels of GSH in women at risk for suicide.”

Even though the study evaluated postpartum women, it’s possible that the results can be extrapolated to other populations, said Dr. Martimbianco de Assis. This is because when the data were collected, 18 months had already passed since giving birth. The participants’ physiological condition at that point was more similar to the one prior to becoming pregnant.

The UCPel researchers continue to follow the cohort. “We intend to continue monitoring GSH levels at other times. Forty-eight months have now passed since the women gave birth, and the idea is to continue studying [the patients involved in the study],” said Dr. Martimbianco de Assis, adding that the team also intends to analyze brain tissue from in vitro studies using cell cultures.

This article was translated from the Medscape Portuguese Edition and a version appeared on Medscape.com.

A mindfulness-based cognitive therapy self-help (MBCT-SH) intervention in which patients were supported by a trained practitioner led to better clinical outcomes at lower cost than practitioner-supported cognitive-behavioral therapy self-help (CBT-SH), new research shows.

The findings suggest that “offering practitioner-supported MBCT-SH as an intervention for mild to moderate depression would improve outcomes and save money compared with practitioner-supported CBT-SH,” noted the investigators, led by Clara Strauss, PhD, DClinPsy, with the University of Sussex School of Psychology in England.

Practitioner-supported CBT-SH is recommended in U.K. national treatment guidelines for mild to moderate depression. However, some patients’ conditions don’t respond, and dropout rates are high.

The Low-Intensity Guided Help Through Mindfulness (LIGHTMind) trial tested practitioner-supported MBCT-SH as an alternative.

The findings have “important implications” for the more than 100,000 people currently offered CBT-SH for depression in the Improving Access to Psychological Therapies (IAPT) program each year and in publicly funded services elsewhere, the researchers noted.

If translated into routine practice, “this would see many more people recovering from depression while costing health services less money,” they added.

The study was published online in JAMA Psychiatry .
 

Practice changing?

The trial included 410 adults (mean age, 32 years; 62% women) with mild to moderate depression who were recruited from 10 publicly funded psychological therapy services in England as part of the IAPT program.

Participants were given one of two established self-help workbooks – The Mindful Way Workbook: An 8-Week Program to Free Yourself from Depression and Emotional Distress, written by the pioneers of MBCT, or Overcoming Depression and Low Mood, 3rd Edition: A Five Areas Approach, which is a CBT-SH program widely used in IAPT.

Use of the self-help books was supported by six structured phone or in-person sessions with a trained psychological well-being practitioner.

The primary outcome was depression symptom severity at 16 weeks, which was determined on the basis of Patient Health Questionnaire 9 (PHQ-9) score.

At 16 weeks following randomization, MBCT-SH led to significantly greater reductions in depression symptom severity compared with CBT-SH (mean PHQ-9 score, 7.2 vs. 8.6; between-group difference, 1.5 points; P = .009; d = −0.36).

MBCT-SH also had superior effects on anxiety symptom severity at 16 weeks.

At the 42-week follow-up, between-group effects on depression and anxiety symptom severity remained in the hypothesized direction but were nonsignificant.

This could be due in part by the greater postintervention psychological therapy accessed by participants in the CBT-SH group, the investigators noted.

Practitioner-supported MBCT-SH was more cost-effective than supported CBT-SH.

On average, the CBT-SH intervention cost health services £526 ($631) more per participant than the MBCT-SH intervention over the 42-week follow-up. The probability of MBCT-SH being cost-effective compared with CBT-SH exceeded 95%, the researchers noted.
 

Useful model for the United States

Commenting for this news organization, Zindel Segal, PhD, professor of psychology, University of Toronto, Scarborough, cautioned against making too much of the differences between the groups, because CBT-SH “trended positive and had a pretty healthy effect size, it just never reached significance.

“I wouldn’t say mindfulness drastically outperformed cognitive therapy. But cognitive therapy is a robust treatment in its own right, and so doing a little bit better is significant,” Dr. Segal said.

He also noted that, appropriately, the trial enrolled adults who were experiencing moderate depression and were not acutely ill. “That’s one of the rationales for self-help compared to providing patients with a more resource-intensive group treatment.

“If you look at the needs of people with moderate depression, what you find is that for cognitive therapy to work, negative thoughts and feelings need to be pervasive in order to make use of the techniques,” Dr. Segal explained.

“With mindfulness, you don’t need any to have constant negative thoughts or feelings. Anything that arises in your experience serves as grist for mill in terms of concentration and focus,” Dr. Segal said.

He also noted that mindfulness-based intervention is “more optimized” for people who are experiencing some measure of recovery or remission.

“It’s well suited for that, as it trends towards the wellness spectrum. But for people who might have greater levels of acuity or severity, cognitive-behavioral therapy might be indicated,” said Dr. Segal.

He also said the U.K. study findings are relevant to U.S. patients with depression.

“While it’s not disseminated in the same way through any kind of national program, the self-help books that are used are widely available, and the support that people were offered, either in person, telephone, or email, could be easily delivered. This would be a very useful model,” Dr. Segal said.

The LIGHTMind trial was funded by the National Institute for Health and Care Research and the Brighton and Sussex Clinical Trials Unit. Dr. Strauss has received grants from Headspace, is research lead for Sussex Mindfulness Centre, and has been chief investigator on National Institute for Health and Care Research. Dr. Segal is one of the authors of the MBCT-SH workbooks used in the study.
 

A version of this article first appeared on Medscape.com.

A mindfulness-based cognitive therapy self-help (MBCT-SH) intervention in which patients were supported by a trained practitioner led to better clinical outcomes at lower cost than practitioner-supported cognitive-behavioral therapy self-help (CBT-SH), new research shows.

The findings suggest that “offering practitioner-supported MBCT-SH as an intervention for mild to moderate depression would improve outcomes and save money compared with practitioner-supported CBT-SH,” noted the investigators, led by Clara Strauss, PhD, DClinPsy, with the University of Sussex School of Psychology in England.

Practitioner-supported CBT-SH is recommended in U.K. national treatment guidelines for mild to moderate depression. However, some patients’ conditions don’t respond, and dropout rates are high.

The Low-Intensity Guided Help Through Mindfulness (LIGHTMind) trial tested practitioner-supported MBCT-SH as an alternative.

The findings have “important implications” for the more than 100,000 people currently offered CBT-SH for depression in the Improving Access to Psychological Therapies (IAPT) program each year and in publicly funded services elsewhere, the researchers noted.

If translated into routine practice, “this would see many more people recovering from depression while costing health services less money,” they added.

The study was published online in JAMA Psychiatry .
 

Practice changing?

The trial included 410 adults (mean age, 32 years; 62% women) with mild to moderate depression who were recruited from 10 publicly funded psychological therapy services in England as part of the IAPT program.

Participants were given one of two established self-help workbooks – The Mindful Way Workbook: An 8-Week Program to Free Yourself from Depression and Emotional Distress, written by the pioneers of MBCT, or Overcoming Depression and Low Mood, 3rd Edition: A Five Areas Approach, which is a CBT-SH program widely used in IAPT.

Use of the self-help books was supported by six structured phone or in-person sessions with a trained psychological well-being practitioner.

The primary outcome was depression symptom severity at 16 weeks, which was determined on the basis of Patient Health Questionnaire 9 (PHQ-9) score.

At 16 weeks following randomization, MBCT-SH led to significantly greater reductions in depression symptom severity compared with CBT-SH (mean PHQ-9 score, 7.2 vs. 8.6; between-group difference, 1.5 points; P = .009; d = −0.36).

MBCT-SH also had superior effects on anxiety symptom severity at 16 weeks.

At the 42-week follow-up, between-group effects on depression and anxiety symptom severity remained in the hypothesized direction but were nonsignificant.

This could be due in part by the greater postintervention psychological therapy accessed by participants in the CBT-SH group, the investigators noted.

Practitioner-supported MBCT-SH was more cost-effective than supported CBT-SH.

On average, the CBT-SH intervention cost health services £526 ($631) more per participant than the MBCT-SH intervention over the 42-week follow-up. The probability of MBCT-SH being cost-effective compared with CBT-SH exceeded 95%, the researchers noted.
 

Useful model for the United States

Commenting for this news organization, Zindel Segal, PhD, professor of psychology, University of Toronto, Scarborough, cautioned against making too much of the differences between the groups, because CBT-SH “trended positive and had a pretty healthy effect size, it just never reached significance.

“I wouldn’t say mindfulness drastically outperformed cognitive therapy. But cognitive therapy is a robust treatment in its own right, and so doing a little bit better is significant,” Dr. Segal said.

He also noted that, appropriately, the trial enrolled adults who were experiencing moderate depression and were not acutely ill. “That’s one of the rationales for self-help compared to providing patients with a more resource-intensive group treatment.

“If you look at the needs of people with moderate depression, what you find is that for cognitive therapy to work, negative thoughts and feelings need to be pervasive in order to make use of the techniques,” Dr. Segal explained.

“With mindfulness, you don’t need any to have constant negative thoughts or feelings. Anything that arises in your experience serves as grist for mill in terms of concentration and focus,” Dr. Segal said.

He also noted that mindfulness-based intervention is “more optimized” for people who are experiencing some measure of recovery or remission.

“It’s well suited for that, as it trends towards the wellness spectrum. But for people who might have greater levels of acuity or severity, cognitive-behavioral therapy might be indicated,” said Dr. Segal.

He also said the U.K. study findings are relevant to U.S. patients with depression.

“While it’s not disseminated in the same way through any kind of national program, the self-help books that are used are widely available, and the support that people were offered, either in person, telephone, or email, could be easily delivered. This would be a very useful model,” Dr. Segal said.

The LIGHTMind trial was funded by the National Institute for Health and Care Research and the Brighton and Sussex Clinical Trials Unit. Dr. Strauss has received grants from Headspace, is research lead for Sussex Mindfulness Centre, and has been chief investigator on National Institute for Health and Care Research. Dr. Segal is one of the authors of the MBCT-SH workbooks used in the study.
 

A version of this article first appeared on Medscape.com.

A mindfulness-based cognitive therapy self-help (MBCT-SH) intervention in which patients were supported by a trained practitioner led to better clinical outcomes at lower cost than practitioner-supported cognitive-behavioral therapy self-help (CBT-SH), new research shows.

The findings suggest that “offering practitioner-supported MBCT-SH as an intervention for mild to moderate depression would improve outcomes and save money compared with practitioner-supported CBT-SH,” noted the investigators, led by Clara Strauss, PhD, DClinPsy, with the University of Sussex School of Psychology in England.

Practitioner-supported CBT-SH is recommended in U.K. national treatment guidelines for mild to moderate depression. However, some patients’ conditions don’t respond, and dropout rates are high.

The Low-Intensity Guided Help Through Mindfulness (LIGHTMind) trial tested practitioner-supported MBCT-SH as an alternative.

The findings have “important implications” for the more than 100,000 people currently offered CBT-SH for depression in the Improving Access to Psychological Therapies (IAPT) program each year and in publicly funded services elsewhere, the researchers noted.

If translated into routine practice, “this would see many more people recovering from depression while costing health services less money,” they added.

The study was published online in JAMA Psychiatry .
 

Practice changing?

The trial included 410 adults (mean age, 32 years; 62% women) with mild to moderate depression who were recruited from 10 publicly funded psychological therapy services in England as part of the IAPT program.

Participants were given one of two established self-help workbooks – The Mindful Way Workbook: An 8-Week Program to Free Yourself from Depression and Emotional Distress, written by the pioneers of MBCT, or Overcoming Depression and Low Mood, 3rd Edition: A Five Areas Approach, which is a CBT-SH program widely used in IAPT.

Use of the self-help books was supported by six structured phone or in-person sessions with a trained psychological well-being practitioner.

The primary outcome was depression symptom severity at 16 weeks, which was determined on the basis of Patient Health Questionnaire 9 (PHQ-9) score.

At 16 weeks following randomization, MBCT-SH led to significantly greater reductions in depression symptom severity compared with CBT-SH (mean PHQ-9 score, 7.2 vs. 8.6; between-group difference, 1.5 points; P = .009; d = −0.36).

MBCT-SH also had superior effects on anxiety symptom severity at 16 weeks.

At the 42-week follow-up, between-group effects on depression and anxiety symptom severity remained in the hypothesized direction but were nonsignificant.

This could be due in part by the greater postintervention psychological therapy accessed by participants in the CBT-SH group, the investigators noted.

Practitioner-supported MBCT-SH was more cost-effective than supported CBT-SH.

On average, the CBT-SH intervention cost health services £526 ($631) more per participant than the MBCT-SH intervention over the 42-week follow-up. The probability of MBCT-SH being cost-effective compared with CBT-SH exceeded 95%, the researchers noted.
 

Useful model for the United States

Commenting for this news organization, Zindel Segal, PhD, professor of psychology, University of Toronto, Scarborough, cautioned against making too much of the differences between the groups, because CBT-SH “trended positive and had a pretty healthy effect size, it just never reached significance.

“I wouldn’t say mindfulness drastically outperformed cognitive therapy. But cognitive therapy is a robust treatment in its own right, and so doing a little bit better is significant,” Dr. Segal said.

He also noted that, appropriately, the trial enrolled adults who were experiencing moderate depression and were not acutely ill. “That’s one of the rationales for self-help compared to providing patients with a more resource-intensive group treatment.

“If you look at the needs of people with moderate depression, what you find is that for cognitive therapy to work, negative thoughts and feelings need to be pervasive in order to make use of the techniques,” Dr. Segal explained.

“With mindfulness, you don’t need any to have constant negative thoughts or feelings. Anything that arises in your experience serves as grist for mill in terms of concentration and focus,” Dr. Segal said.

He also noted that mindfulness-based intervention is “more optimized” for people who are experiencing some measure of recovery or remission.

“It’s well suited for that, as it trends towards the wellness spectrum. But for people who might have greater levels of acuity or severity, cognitive-behavioral therapy might be indicated,” said Dr. Segal.

He also said the U.K. study findings are relevant to U.S. patients with depression.

“While it’s not disseminated in the same way through any kind of national program, the self-help books that are used are widely available, and the support that people were offered, either in person, telephone, or email, could be easily delivered. This would be a very useful model,” Dr. Segal said.

The LIGHTMind trial was funded by the National Institute for Health and Care Research and the Brighton and Sussex Clinical Trials Unit. Dr. Strauss has received grants from Headspace, is research lead for Sussex Mindfulness Centre, and has been chief investigator on National Institute for Health and Care Research. Dr. Segal is one of the authors of the MBCT-SH workbooks used in the study.
 

A version of this article first appeared on Medscape.com.

PARIS – Listening to music via curated playlists at bedtime is effective for depression-related insomnia, although the depression itself is unaffected, new research suggests.

The Music to Improve Sleep Quality in Adults With Depression and Insomnia (MUSTAFI) trial randomly assigned more than 110 outpatients with depression to either a music intervention or a waiting list. Sleep quality and quality of life significantly improved after listening to music for half an hour at bedtime for 4 weeks.

“This is a low-cost, safe intervention that has no side effects and may easily be implemented in psychiatry” along with existing treatments, lead researcher Helle Nystrup Lund, PhD, unit for depression, Aalborg (Denmark) University Hospital, said in an interview.

The findings were presented at the European Psychiatric Association 2023 Congress, and recently published in the Nordic Journal of Psychiatry.
 

Difficult to resolve

The researchers noted that insomnia is common in patients with depression and is “difficult to resolve.”

They noted that, while music is commonly used as a sleep aid and a growing evidence base suggests it has positive effects, there have been few investigations into the effectiveness of music for patients with depression-related insomnia.

To fill this research gap, 112 outpatients with depression and comorbid insomnia who were receiving care at a single center were randomly assigned to either an intervention group or a wait list control group.

Participants in the intervention group listened to music for a minimum of 30 minutes at bedtime for 4 weeks. The music was delivered via the MusicStar app, which is available as a free download from the Apple and Android (Google Play) app stores. The app was developed by Dr. Lund and Lars Rye Bertelsen, a PhD student and music therapist at Aalborg University Hospital.

The app is designed as a multicolored star, with each arm of the star linking to a playlist lasting between 30 minutes and 1 hour. Each color of the star indicates a different tempo of music.

Blue playlists, Dr. Lund explained, offer the quietest music, green is more lively, and red is the most dynamic. Gray playlists linked to project-related soundtracks, such as summer rain.

Dr. Lund said organizing the playlists by stimuli and color code, instead of genre, allows users to regulate their level of arousal and makes the music choice intuitive and easy.

She said that the genres of music include New Age, folk, pop, classical, and film soundtracks, “but no hard rock.”

“There’s actually a quite large selection of music available, because studies show that individual choice is important, as are personal preferences,” she said, adding that the endless choices offered by streaming services can cause confusion.

“So we made curated playlists and designed them with well-known pieces, but also with newly composed music not associated with anything,” Dr. Lund said.

Participants were assessed using the Pittsburgh Sleep Quality Index (PSQI), the Hamilton Depression Rating Scale, and two World Health Organization well-being questionnaires (WHO-5, WHOQOL-BREF), as well as actigraphy.

Results showed that, at 4 weeks, participants in the intervention group experienced significant improvements in sleep quality in comparison with control persons. The effect size for the PSQI was –2.1, and for quality of life on the WHO-5, the effect size was 8.4.

A subanalysis revealed that the length of nocturnal sleep in the intervention group increased by an average of 18 minutes during the study from a baseline of approximately 5 hours per night, said Dr. Lund.

However, there were no changes in actigraphy measurements and no significant improvements in HAMD-17 scores.

Dr. Lund said that, on the basis of these positive findings, music intervention as a sleep aid is now offered at Aalborg University Hospital to patients with depression-related insomnia.
 

Clinically meaningful?

Commenting on the findings, Gerald J. Haeffel, PhD, department of psychology, University of Notre Dame, South Bend, Ind., said that overall, the study showed there was a change in sleep-quality and quality of life scores of “about 10% in each.”

“This, on the surface, would seem to be a meaningful change,” although it is less clear whether it is “clinically meaningful.” Perhaps it is, “but it would be nice to have more information.”

It would be useful, he said, to “show the means for each group pre- to postintervention, along with standard deviations,” he added.

Dr. Haeffel added that on the basis of current results, it isn’t possible to determine whether individuals’ control over music choice is important.

“We have no idea if ‘choice’ or length of playlist had any causal role in the results. One would need to run a study with the same playlist, but in one group people have to listen to whatever song comes on versus another condition in which they get to choose a song off the same list,” he said.

He noted that his group conducted a study in which highly popular music that was chosen by individual participants was found to have a positive effect. Even so, he said, “we could not determine if it was ‘choice’ or ‘popularity’ that caused the positive effects of music.”

In addition, he said, the reason music has a positive effect on insomnia remains unclear.

“It is not because it helped with depression, and it’s not because it’s actually changing objective sleep parameters. It could be that it improves mood right before bed or helps distract people right before bed. At the same time, it could also just be a placebo effect,” said Dr. Haeffel.

In addition, he said, it’s important to note that the music intervention had no comparator, so “maybe just doing something different or getting to talk with researchers created the effect and has nothing to do with music.”

Overall, he believes that there are “not enough data” to use the sleep intervention that was employed in the current study “as primary intervention, but future work could show its usefulness as a supplement.”

Dr. Lund and Mr. Bertelsen reported ownership and sales of the MusicStar app. Dr. Haeffel reported no relevant financial relationships.

PARIS – Listening to music via curated playlists at bedtime is effective for depression-related insomnia, although the depression itself is unaffected, new research suggests.

The Music to Improve Sleep Quality in Adults With Depression and Insomnia (MUSTAFI) trial randomly assigned more than 110 outpatients with depression to either a music intervention or a waiting list. Sleep quality and quality of life significantly improved after listening to music for half an hour at bedtime for 4 weeks.

“This is a low-cost, safe intervention that has no side effects and may easily be implemented in psychiatry” along with existing treatments, lead researcher Helle Nystrup Lund, PhD, unit for depression, Aalborg (Denmark) University Hospital, said in an interview.

The findings were presented at the European Psychiatric Association 2023 Congress, and recently published in the Nordic Journal of Psychiatry.
 

Difficult to resolve

The researchers noted that insomnia is common in patients with depression and is “difficult to resolve.”

They noted that, while music is commonly used as a sleep aid and a growing evidence base suggests it has positive effects, there have been few investigations into the effectiveness of music for patients with depression-related insomnia.

To fill this research gap, 112 outpatients with depression and comorbid insomnia who were receiving care at a single center were randomly assigned to either an intervention group or a wait list control group.

Participants in the intervention group listened to music for a minimum of 30 minutes at bedtime for 4 weeks. The music was delivered via the MusicStar app, which is available as a free download from the Apple and Android (Google Play) app stores. The app was developed by Dr. Lund and Lars Rye Bertelsen, a PhD student and music therapist at Aalborg University Hospital.

The app is designed as a multicolored star, with each arm of the star linking to a playlist lasting between 30 minutes and 1 hour. Each color of the star indicates a different tempo of music.

Blue playlists, Dr. Lund explained, offer the quietest music, green is more lively, and red is the most dynamic. Gray playlists linked to project-related soundtracks, such as summer rain.

Dr. Lund said organizing the playlists by stimuli and color code, instead of genre, allows users to regulate their level of arousal and makes the music choice intuitive and easy.

She said that the genres of music include New Age, folk, pop, classical, and film soundtracks, “but no hard rock.”

“There’s actually a quite large selection of music available, because studies show that individual choice is important, as are personal preferences,” she said, adding that the endless choices offered by streaming services can cause confusion.

“So we made curated playlists and designed them with well-known pieces, but also with newly composed music not associated with anything,” Dr. Lund said.

Participants were assessed using the Pittsburgh Sleep Quality Index (PSQI), the Hamilton Depression Rating Scale, and two World Health Organization well-being questionnaires (WHO-5, WHOQOL-BREF), as well as actigraphy.

Results showed that, at 4 weeks, participants in the intervention group experienced significant improvements in sleep quality in comparison with control persons. The effect size for the PSQI was –2.1, and for quality of life on the WHO-5, the effect size was 8.4.

A subanalysis revealed that the length of nocturnal sleep in the intervention group increased by an average of 18 minutes during the study from a baseline of approximately 5 hours per night, said Dr. Lund.

However, there were no changes in actigraphy measurements and no significant improvements in HAMD-17 scores.

Dr. Lund said that, on the basis of these positive findings, music intervention as a sleep aid is now offered at Aalborg University Hospital to patients with depression-related insomnia.
 

Clinically meaningful?

Commenting on the findings, Gerald J. Haeffel, PhD, department of psychology, University of Notre Dame, South Bend, Ind., said that overall, the study showed there was a change in sleep-quality and quality of life scores of “about 10% in each.”

“This, on the surface, would seem to be a meaningful change,” although it is less clear whether it is “clinically meaningful.” Perhaps it is, “but it would be nice to have more information.”

It would be useful, he said, to “show the means for each group pre- to postintervention, along with standard deviations,” he added.

Dr. Haeffel added that on the basis of current results, it isn’t possible to determine whether individuals’ control over music choice is important.

“We have no idea if ‘choice’ or length of playlist had any causal role in the results. One would need to run a study with the same playlist, but in one group people have to listen to whatever song comes on versus another condition in which they get to choose a song off the same list,” he said.

He noted that his group conducted a study in which highly popular music that was chosen by individual participants was found to have a positive effect. Even so, he said, “we could not determine if it was ‘choice’ or ‘popularity’ that caused the positive effects of music.”

In addition, he said, the reason music has a positive effect on insomnia remains unclear.

“It is not because it helped with depression, and it’s not because it’s actually changing objective sleep parameters. It could be that it improves mood right before bed or helps distract people right before bed. At the same time, it could also just be a placebo effect,” said Dr. Haeffel.

In addition, he said, it’s important to note that the music intervention had no comparator, so “maybe just doing something different or getting to talk with researchers created the effect and has nothing to do with music.”

Overall, he believes that there are “not enough data” to use the sleep intervention that was employed in the current study “as primary intervention, but future work could show its usefulness as a supplement.”

Dr. Lund and Mr. Bertelsen reported ownership and sales of the MusicStar app. Dr. Haeffel reported no relevant financial relationships.

PARIS – Listening to music via curated playlists at bedtime is effective for depression-related insomnia, although the depression itself is unaffected, new research suggests.

The Music to Improve Sleep Quality in Adults With Depression and Insomnia (MUSTAFI) trial randomly assigned more than 110 outpatients with depression to either a music intervention or a waiting list. Sleep quality and quality of life significantly improved after listening to music for half an hour at bedtime for 4 weeks.

“This is a low-cost, safe intervention that has no side effects and may easily be implemented in psychiatry” along with existing treatments, lead researcher Helle Nystrup Lund, PhD, unit for depression, Aalborg (Denmark) University Hospital, said in an interview.

The findings were presented at the European Psychiatric Association 2023 Congress, and recently published in the Nordic Journal of Psychiatry.
 

Difficult to resolve

The researchers noted that insomnia is common in patients with depression and is “difficult to resolve.”

They noted that, while music is commonly used as a sleep aid and a growing evidence base suggests it has positive effects, there have been few investigations into the effectiveness of music for patients with depression-related insomnia.

To fill this research gap, 112 outpatients with depression and comorbid insomnia who were receiving care at a single center were randomly assigned to either an intervention group or a wait list control group.

Participants in the intervention group listened to music for a minimum of 30 minutes at bedtime for 4 weeks. The music was delivered via the MusicStar app, which is available as a free download from the Apple and Android (Google Play) app stores. The app was developed by Dr. Lund and Lars Rye Bertelsen, a PhD student and music therapist at Aalborg University Hospital.

The app is designed as a multicolored star, with each arm of the star linking to a playlist lasting between 30 minutes and 1 hour. Each color of the star indicates a different tempo of music.

Blue playlists, Dr. Lund explained, offer the quietest music, green is more lively, and red is the most dynamic. Gray playlists linked to project-related soundtracks, such as summer rain.

Dr. Lund said organizing the playlists by stimuli and color code, instead of genre, allows users to regulate their level of arousal and makes the music choice intuitive and easy.

She said that the genres of music include New Age, folk, pop, classical, and film soundtracks, “but no hard rock.”

“There’s actually a quite large selection of music available, because studies show that individual choice is important, as are personal preferences,” she said, adding that the endless choices offered by streaming services can cause confusion.

“So we made curated playlists and designed them with well-known pieces, but also with newly composed music not associated with anything,” Dr. Lund said.

Participants were assessed using the Pittsburgh Sleep Quality Index (PSQI), the Hamilton Depression Rating Scale, and two World Health Organization well-being questionnaires (WHO-5, WHOQOL-BREF), as well as actigraphy.

Results showed that, at 4 weeks, participants in the intervention group experienced significant improvements in sleep quality in comparison with control persons. The effect size for the PSQI was –2.1, and for quality of life on the WHO-5, the effect size was 8.4.

A subanalysis revealed that the length of nocturnal sleep in the intervention group increased by an average of 18 minutes during the study from a baseline of approximately 5 hours per night, said Dr. Lund.

However, there were no changes in actigraphy measurements and no significant improvements in HAMD-17 scores.

Dr. Lund said that, on the basis of these positive findings, music intervention as a sleep aid is now offered at Aalborg University Hospital to patients with depression-related insomnia.
 

Clinically meaningful?

Commenting on the findings, Gerald J. Haeffel, PhD, department of psychology, University of Notre Dame, South Bend, Ind., said that overall, the study showed there was a change in sleep-quality and quality of life scores of “about 10% in each.”

“This, on the surface, would seem to be a meaningful change,” although it is less clear whether it is “clinically meaningful.” Perhaps it is, “but it would be nice to have more information.”

It would be useful, he said, to “show the means for each group pre- to postintervention, along with standard deviations,” he added.

Dr. Haeffel added that on the basis of current results, it isn’t possible to determine whether individuals’ control over music choice is important.

“We have no idea if ‘choice’ or length of playlist had any causal role in the results. One would need to run a study with the same playlist, but in one group people have to listen to whatever song comes on versus another condition in which they get to choose a song off the same list,” he said.

He noted that his group conducted a study in which highly popular music that was chosen by individual participants was found to have a positive effect. Even so, he said, “we could not determine if it was ‘choice’ or ‘popularity’ that caused the positive effects of music.”

In addition, he said, the reason music has a positive effect on insomnia remains unclear.

“It is not because it helped with depression, and it’s not because it’s actually changing objective sleep parameters. It could be that it improves mood right before bed or helps distract people right before bed. At the same time, it could also just be a placebo effect,” said Dr. Haeffel.

In addition, he said, it’s important to note that the music intervention had no comparator, so “maybe just doing something different or getting to talk with researchers created the effect and has nothing to do with music.”

Overall, he believes that there are “not enough data” to use the sleep intervention that was employed in the current study “as primary intervention, but future work could show its usefulness as a supplement.”

Dr. Lund and Mr. Bertelsen reported ownership and sales of the MusicStar app. Dr. Haeffel reported no relevant financial relationships.

Intranasal esketamine is an FDA-approved ketamine molecule indicated for use together with an oral antidepressant for treatment-resistant depression (TRD) in patients age ≥18 who have had an inadequate response to ≥2 antidepressants, and for depressive symptoms in adults with major depressive disorder with suicidal thoughts or actions.¹ Since March 2019, we’ve been treating patients with intranasal esketamine. Based on our experiences, here is a summary of what we have learned.

REMS is required. Due to the potential risks resulting from sedation and dissociation caused by esketamine and the risk of abuse and misuse, esketamine is available only through a Risk Evaluation and Mitigation Strategy (REMS) program. The program links your office Drug Enforcement Administration number to the address where this schedule III medication will be stored and given to the patient for self-administration. Requirements and other details about the REMS are available at www.spravatorems.com.

Treatment. Start with the online REMS patient enrollment/consent form. Contra­indications include having a history of aneurysmal vascular disease, intracerebral hemorrhage, or allergy to ketamine/esketamine. Adjunctive treatment with esketamine plus sertraline, escitalopram, venlafaxine, or duloxetine are comparably effective.¹ We have found that adding magnesium to block glutamate action at N-methyl-D-aspartate (NMDA) receptors, bupropion, and the oral NMDA receptor antagonist dextromethorphan may amplify and prolong esketamine’s therapeutic effects. Titrate to a maximum tolerated dose of 3 devices (84 mg total), 5 minutes apart. Administer esketamine twice weekly for 4 weeks, then weekly for the next 4 weeks (for TRD), and continue weekly or twice monthly.¹ Open-label clinical trial data over 4 years support continuing treatment for relapse prevention, and have not reported the long-term cognitive impairment or ulcerative/interstitial cystitis associated with frequent, chronic ketamine use.² TRD clinical trials have shown a response rate (>50% reduction in baseline Montgomery-Åsberg Depression Rating Scale score) of 70% by the end of Week 4, emerging at 4 hours, independent of dissociation.³

Iatrogenic effects rarely lead to dropout. The first session is critical to allay anticipatory anxiety. Sedation, blood pressure increase, and dissociation are common but transient adverse effects that typically peak at 40 minutes and resolve by 90 minutes. Record blood pressure on a REMS monitoring form before treatment, at 40 minutes, and at 2 hours. Avoid administering sedative or prohypertensive medications together with esketamine.¹ Dissociation is more common in patients with a history of trauma. Combine music, guided image­ry, or psychotherapy to harness this for therapeutic benefit. Sleepiness can last 4 hours; make sure the patient has arranged for a ride home, as they cannot drive until the next day. Verify normal blood pressure before starting treatment. Clonidine or labetalol for hypertension/severe dissociation and ondansetron or prochlorperazine for nausea are rarely needed. Advise patients to use the bathroom before treatment and keep a trash can nearby for vomiting. Other transient adverse effects found in TRD clinical trials that occurred >5% and twice that of placebo were dizziness, vertigo, numbness, and feeling drunk.¹

Reimbursement for treatment with esketamine is available through most insurances, including copay cards, rebates, deductible support, and free assistance programs. Coverage is either through pharmacy benefit, assignment of medical benefit (pharmacy handles the medical benefit), or medical benefit with remuneration above wholesale price.

Zeitgeist shift. Emergency departments are backlogged and patients languish waiting to feel the effects of oral antidepressants. Intranasal esketamine could help alleviate this situation by producing a more immediate response. We also have observed improvements in comorbid posttraumatic stress disorder and in cognitive deficits of dementia, possibly due to rapidly enhanced neuroplasticity, neurogenesis, and astrocyte functioning, which NMDA receptor antagonism, AMPA activation, and downstream mediators (eg, brain-derived neurotrophic factor) may promote.⁴

Intranasal esketamine is an FDA-approved ketamine molecule indicated for use together with an oral antidepressant for treatment-resistant depression (TRD) in patients age ≥18 who have had an inadequate response to ≥2 antidepressants, and for depressive symptoms in adults with major depressive disorder with suicidal thoughts or actions.¹ Since March 2019, we’ve been treating patients with intranasal esketamine. Based on our experiences, here is a summary of what we have learned.

REMS is required. Due to the potential risks resulting from sedation and dissociation caused by esketamine and the risk of abuse and misuse, esketamine is available only through a Risk Evaluation and Mitigation Strategy (REMS) program. The program links your office Drug Enforcement Administration number to the address where this schedule III medication will be stored and given to the patient for self-administration. Requirements and other details about the REMS are available at www.spravatorems.com.

Treatment. Start with the online REMS patient enrollment/consent form. Contra­indications include having a history of aneurysmal vascular disease, intracerebral hemorrhage, or allergy to ketamine/esketamine. Adjunctive treatment with esketamine plus sertraline, escitalopram, venlafaxine, or duloxetine are comparably effective.¹ We have found that adding magnesium to block glutamate action at N-methyl-D-aspartate (NMDA) receptors, bupropion, and the oral NMDA receptor antagonist dextromethorphan may amplify and prolong esketamine’s therapeutic effects. Titrate to a maximum tolerated dose of 3 devices (84 mg total), 5 minutes apart. Administer esketamine twice weekly for 4 weeks, then weekly for the next 4 weeks (for TRD), and continue weekly or twice monthly.¹ Open-label clinical trial data over 4 years support continuing treatment for relapse prevention, and have not reported the long-term cognitive impairment or ulcerative/interstitial cystitis associated with frequent, chronic ketamine use.² TRD clinical trials have shown a response rate (>50% reduction in baseline Montgomery-Åsberg Depression Rating Scale score) of 70% by the end of Week 4, emerging at 4 hours, independent of dissociation.³

Iatrogenic effects rarely lead to dropout. The first session is critical to allay anticipatory anxiety. Sedation, blood pressure increase, and dissociation are common but transient adverse effects that typically peak at 40 minutes and resolve by 90 minutes. Record blood pressure on a REMS monitoring form before treatment, at 40 minutes, and at 2 hours. Avoid administering sedative or prohypertensive medications together with esketamine.¹ Dissociation is more common in patients with a history of trauma. Combine music, guided image­ry, or psychotherapy to harness this for therapeutic benefit. Sleepiness can last 4 hours; make sure the patient has arranged for a ride home, as they cannot drive until the next day. Verify normal blood pressure before starting treatment. Clonidine or labetalol for hypertension/severe dissociation and ondansetron or prochlorperazine for nausea are rarely needed. Advise patients to use the bathroom before treatment and keep a trash can nearby for vomiting. Other transient adverse effects found in TRD clinical trials that occurred >5% and twice that of placebo were dizziness, vertigo, numbness, and feeling drunk.¹

Reimbursement for treatment with esketamine is available through most insurances, including copay cards, rebates, deductible support, and free assistance programs. Coverage is either through pharmacy benefit, assignment of medical benefit (pharmacy handles the medical benefit), or medical benefit with remuneration above wholesale price.

Zeitgeist shift. Emergency departments are backlogged and patients languish waiting to feel the effects of oral antidepressants. Intranasal esketamine could help alleviate this situation by producing a more immediate response. We also have observed improvements in comorbid posttraumatic stress disorder and in cognitive deficits of dementia, possibly due to rapidly enhanced neuroplasticity, neurogenesis, and astrocyte functioning, which NMDA receptor antagonism, AMPA activation, and downstream mediators (eg, brain-derived neurotrophic factor) may promote.⁴

Intranasal esketamine is an FDA-approved ketamine molecule indicated for use together with an oral antidepressant for treatment-resistant depression (TRD) in patients age ≥18 who have had an inadequate response to ≥2 antidepressants, and for depressive symptoms in adults with major depressive disorder with suicidal thoughts or actions.¹ Since March 2019, we’ve been treating patients with intranasal esketamine. Based on our experiences, here is a summary of what we have learned.

REMS is required. Due to the potential risks resulting from sedation and dissociation caused by esketamine and the risk of abuse and misuse, esketamine is available only through a Risk Evaluation and Mitigation Strategy (REMS) program. The program links your office Drug Enforcement Administration number to the address where this schedule III medication will be stored and given to the patient for self-administration. Requirements and other details about the REMS are available at www.spravatorems.com.

Treatment. Start with the online REMS patient enrollment/consent form. Contra­indications include having a history of aneurysmal vascular disease, intracerebral hemorrhage, or allergy to ketamine/esketamine. Adjunctive treatment with esketamine plus sertraline, escitalopram, venlafaxine, or duloxetine are comparably effective.¹ We have found that adding magnesium to block glutamate action at N-methyl-D-aspartate (NMDA) receptors, bupropion, and the oral NMDA receptor antagonist dextromethorphan may amplify and prolong esketamine’s therapeutic effects. Titrate to a maximum tolerated dose of 3 devices (84 mg total), 5 minutes apart. Administer esketamine twice weekly for 4 weeks, then weekly for the next 4 weeks (for TRD), and continue weekly or twice monthly.¹ Open-label clinical trial data over 4 years support continuing treatment for relapse prevention, and have not reported the long-term cognitive impairment or ulcerative/interstitial cystitis associated with frequent, chronic ketamine use.² TRD clinical trials have shown a response rate (>50% reduction in baseline Montgomery-Åsberg Depression Rating Scale score) of 70% by the end of Week 4, emerging at 4 hours, independent of dissociation.³

Iatrogenic effects rarely lead to dropout. The first session is critical to allay anticipatory anxiety. Sedation, blood pressure increase, and dissociation are common but transient adverse effects that typically peak at 40 minutes and resolve by 90 minutes. Record blood pressure on a REMS monitoring form before treatment, at 40 minutes, and at 2 hours. Avoid administering sedative or prohypertensive medications together with esketamine.¹ Dissociation is more common in patients with a history of trauma. Combine music, guided image­ry, or psychotherapy to harness this for therapeutic benefit. Sleepiness can last 4 hours; make sure the patient has arranged for a ride home, as they cannot drive until the next day. Verify normal blood pressure before starting treatment. Clonidine or labetalol for hypertension/severe dissociation and ondansetron or prochlorperazine for nausea are rarely needed. Advise patients to use the bathroom before treatment and keep a trash can nearby for vomiting. Other transient adverse effects found in TRD clinical trials that occurred >5% and twice that of placebo were dizziness, vertigo, numbness, and feeling drunk.¹

Reimbursement for treatment with esketamine is available through most insurances, including copay cards, rebates, deductible support, and free assistance programs. Coverage is either through pharmacy benefit, assignment of medical benefit (pharmacy handles the medical benefit), or medical benefit with remuneration above wholesale price.

Zeitgeist shift. Emergency departments are backlogged and patients languish waiting to feel the effects of oral antidepressants. Intranasal esketamine could help alleviate this situation by producing a more immediate response. We also have observed improvements in comorbid posttraumatic stress disorder and in cognitive deficits of dementia, possibly due to rapidly enhanced neuroplasticity, neurogenesis, and astrocyte functioning, which NMDA receptor antagonism, AMPA activation, and downstream mediators (eg, brain-derived neurotrophic factor) may promote.⁴

A couple of weeks ago I stumbled across a report of a Pew Research Center’s survey titled “Parenting in America today” (Pew Research Center. Jan. 24, 2023), which found that 40% of parents in the United States with children younger than 18 are “extremely or very worried” that at some point their children might struggle with anxiety or depression. Thirty-six percent replied that they were “somewhat” worried. This total of more than 75% represents a significant change from the 2015 Pew Center survey in which only 54% of parents were “somewhat” worried about their children’s mental health.

Prompted by these findings I began work on a column in which I planned to encourage pediatricians to think more like family physicians when we were working with children who were experiencing serious mental health problems. My primary message was going to be that we should turn more of our attention to the mental health of the anxious parents who must endure the often long and frustrating path toward effective psychiatric care for their children. This might come in the form of some simple suggestions about nonpharmacologic self-help strategies. Or, it could mean encouraging parents to seek psychiatric care or counseling for themselves as they wait for help for their child.

However, as I began that column, my thoughts kept drifting toward a broader consideration of the relationship between parents and pediatric mental health. If mental health of children is causing their parents to be anxious and depressed isn’t it just as likely that this is a bidirectional connection? This was not exactly an “aha” moment for me because it is a relationship I have considered for sometime. However, it is a concept that I have come to realize is receiving far too little attention.

There are exceptions. For example, a recent opinion piece in the New York Times by David French, “What if Kids Are Sad and Stressed Because Their Parents Are?” (March 19, 2023) echoes many of my concerns. Drawing on his experiences traveling around college campuses, Mr. French observes, “Just as parents are upset about their children’s anxiety and depression, children are anxious about their parent’s mental health.”

He notes that an August 2022 NBC News poll found that 58% of registered voters feel this country’s best days are behind it and joins me in imagining that this negative mind set is filtering down to the pediatric population. He acknowledges that there are other likely contributors to teen unhappiness including the ubiquity of smart phones, the secularization of society, and the media’s focus on the political divide. However, Mr. French wonders if the parenting style that results in childhood experiences that are dominated by adult supervision and protection may also be playing a large role.

In his conclusion, Mr. French asks us to consider “How much fear and anxiety should we import to our lives and homes?” as we adults search for an answer.

As I continued to drill down for other possible solutions, I encountered an avenue of psychological research that suggests that instead of, or in addition to, filtering out the anxiety-generating deluge of information, we begin to give some thought to how our beliefs may be coloring our perception of reality.

Jeremy D.W. Clifton, PhD, a psychologist at the University of Pennsylvania Positive Psychology Center has done extensive research on the relationship between our basic beliefs about the world (known as primal beliefs or simply primals in psychologist lingo) and how we interpret reality. For example, one of your primal beliefs may be that the world is a dangerous place. I, on the other hand, may see the world as a stimulating environment offering me endless opportunities to explore. I may see the world as an abundant resource limited only by my creativity. You, however, see it as a barren wasteland.

Dr. Clifton’s research has shown that our primals (at least those of adults) are relatively immutable through one’s lifetime and “do not appear to be the consequence of our experiences.” For example, living in a ZIP code with a high crime rate does not predict that you will see the world as a dangerous place. Nor does being affluent guarantee that an adult sees the world rich with opportunities.

It is unclear exactly when and by what process we develop our primal beliefs, but it is safe to say our parents probably play a large role. Exactly to what degree the tsunami of bad news we are allowing to inundate our children’s lives plays a role is unclear. However, it is reasonable to assume that news about climate change, school shootings, and the pandemic must be a contributor.

According to Dr. Clifton, there is some evidence that certain mind exercises, when applied diligently, can occasionally modify the primal beliefs of an individual who sees the world as dangerous and barren. Until such strategies become more readily accessible, the best we can do is acknowledge that our children are like canaries in a coal mine full of negative perceptions, then do our best to clear the air.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A couple of weeks ago I stumbled across a report of a Pew Research Center’s survey titled “Parenting in America today” (Pew Research Center. Jan. 24, 2023), which found that 40% of parents in the United States with children younger than 18 are “extremely or very worried” that at some point their children might struggle with anxiety or depression. Thirty-six percent replied that they were “somewhat” worried. This total of more than 75% represents a significant change from the 2015 Pew Center survey in which only 54% of parents were “somewhat” worried about their children’s mental health.

Prompted by these findings I began work on a column in which I planned to encourage pediatricians to think more like family physicians when we were working with children who were experiencing serious mental health problems. My primary message was going to be that we should turn more of our attention to the mental health of the anxious parents who must endure the often long and frustrating path toward effective psychiatric care for their children. This might come in the form of some simple suggestions about nonpharmacologic self-help strategies. Or, it could mean encouraging parents to seek psychiatric care or counseling for themselves as they wait for help for their child.

However, as I began that column, my thoughts kept drifting toward a broader consideration of the relationship between parents and pediatric mental health. If mental health of children is causing their parents to be anxious and depressed isn’t it just as likely that this is a bidirectional connection? This was not exactly an “aha” moment for me because it is a relationship I have considered for sometime. However, it is a concept that I have come to realize is receiving far too little attention.

There are exceptions. For example, a recent opinion piece in the New York Times by David French, “What if Kids Are Sad and Stressed Because Their Parents Are?” (March 19, 2023) echoes many of my concerns. Drawing on his experiences traveling around college campuses, Mr. French observes, “Just as parents are upset about their children’s anxiety and depression, children are anxious about their parent’s mental health.”

He notes that an August 2022 NBC News poll found that 58% of registered voters feel this country’s best days are behind it and joins me in imagining that this negative mind set is filtering down to the pediatric population. He acknowledges that there are other likely contributors to teen unhappiness including the ubiquity of smart phones, the secularization of society, and the media’s focus on the political divide. However, Mr. French wonders if the parenting style that results in childhood experiences that are dominated by adult supervision and protection may also be playing a large role.

In his conclusion, Mr. French asks us to consider “How much fear and anxiety should we import to our lives and homes?” as we adults search for an answer.

As I continued to drill down for other possible solutions, I encountered an avenue of psychological research that suggests that instead of, or in addition to, filtering out the anxiety-generating deluge of information, we begin to give some thought to how our beliefs may be coloring our perception of reality.

Jeremy D.W. Clifton, PhD, a psychologist at the University of Pennsylvania Positive Psychology Center has done extensive research on the relationship between our basic beliefs about the world (known as primal beliefs or simply primals in psychologist lingo) and how we interpret reality. For example, one of your primal beliefs may be that the world is a dangerous place. I, on the other hand, may see the world as a stimulating environment offering me endless opportunities to explore. I may see the world as an abundant resource limited only by my creativity. You, however, see it as a barren wasteland.

Dr. Clifton’s research has shown that our primals (at least those of adults) are relatively immutable through one’s lifetime and “do not appear to be the consequence of our experiences.” For example, living in a ZIP code with a high crime rate does not predict that you will see the world as a dangerous place. Nor does being affluent guarantee that an adult sees the world rich with opportunities.

It is unclear exactly when and by what process we develop our primal beliefs, but it is safe to say our parents probably play a large role. Exactly to what degree the tsunami of bad news we are allowing to inundate our children’s lives plays a role is unclear. However, it is reasonable to assume that news about climate change, school shootings, and the pandemic must be a contributor.

According to Dr. Clifton, there is some evidence that certain mind exercises, when applied diligently, can occasionally modify the primal beliefs of an individual who sees the world as dangerous and barren. Until such strategies become more readily accessible, the best we can do is acknowledge that our children are like canaries in a coal mine full of negative perceptions, then do our best to clear the air.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A couple of weeks ago I stumbled across a report of a Pew Research Center’s survey titled “Parenting in America today” (Pew Research Center. Jan. 24, 2023), which found that 40% of parents in the United States with children younger than 18 are “extremely or very worried” that at some point their children might struggle with anxiety or depression. Thirty-six percent replied that they were “somewhat” worried. This total of more than 75% represents a significant change from the 2015 Pew Center survey in which only 54% of parents were “somewhat” worried about their children’s mental health.

Prompted by these findings I began work on a column in which I planned to encourage pediatricians to think more like family physicians when we were working with children who were experiencing serious mental health problems. My primary message was going to be that we should turn more of our attention to the mental health of the anxious parents who must endure the often long and frustrating path toward effective psychiatric care for their children. This might come in the form of some simple suggestions about nonpharmacologic self-help strategies. Or, it could mean encouraging parents to seek psychiatric care or counseling for themselves as they wait for help for their child.

However, as I began that column, my thoughts kept drifting toward a broader consideration of the relationship between parents and pediatric mental health. If mental health of children is causing their parents to be anxious and depressed isn’t it just as likely that this is a bidirectional connection? This was not exactly an “aha” moment for me because it is a relationship I have considered for sometime. However, it is a concept that I have come to realize is receiving far too little attention.

There are exceptions. For example, a recent opinion piece in the New York Times by David French, “What if Kids Are Sad and Stressed Because Their Parents Are?” (March 19, 2023) echoes many of my concerns. Drawing on his experiences traveling around college campuses, Mr. French observes, “Just as parents are upset about their children’s anxiety and depression, children are anxious about their parent’s mental health.”

He notes that an August 2022 NBC News poll found that 58% of registered voters feel this country’s best days are behind it and joins me in imagining that this negative mind set is filtering down to the pediatric population. He acknowledges that there are other likely contributors to teen unhappiness including the ubiquity of smart phones, the secularization of society, and the media’s focus on the political divide. However, Mr. French wonders if the parenting style that results in childhood experiences that are dominated by adult supervision and protection may also be playing a large role.

In his conclusion, Mr. French asks us to consider “How much fear and anxiety should we import to our lives and homes?” as we adults search for an answer.

As I continued to drill down for other possible solutions, I encountered an avenue of psychological research that suggests that instead of, or in addition to, filtering out the anxiety-generating deluge of information, we begin to give some thought to how our beliefs may be coloring our perception of reality.

Jeremy D.W. Clifton, PhD, a psychologist at the University of Pennsylvania Positive Psychology Center has done extensive research on the relationship between our basic beliefs about the world (known as primal beliefs or simply primals in psychologist lingo) and how we interpret reality. For example, one of your primal beliefs may be that the world is a dangerous place. I, on the other hand, may see the world as a stimulating environment offering me endless opportunities to explore. I may see the world as an abundant resource limited only by my creativity. You, however, see it as a barren wasteland.

Dr. Clifton’s research has shown that our primals (at least those of adults) are relatively immutable through one’s lifetime and “do not appear to be the consequence of our experiences.” For example, living in a ZIP code with a high crime rate does not predict that you will see the world as a dangerous place. Nor does being affluent guarantee that an adult sees the world rich with opportunities.

It is unclear exactly when and by what process we develop our primal beliefs, but it is safe to say our parents probably play a large role. Exactly to what degree the tsunami of bad news we are allowing to inundate our children’s lives plays a role is unclear. However, it is reasonable to assume that news about climate change, school shootings, and the pandemic must be a contributor.

According to Dr. Clifton, there is some evidence that certain mind exercises, when applied diligently, can occasionally modify the primal beliefs of an individual who sees the world as dangerous and barren. Until such strategies become more readily accessible, the best we can do is acknowledge that our children are like canaries in a coal mine full of negative perceptions, then do our best to clear the air.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

PARIS – Childhood trauma affects women and men equally in terms of its impact on subsequent psychopathology, but trauma type has subsequent differential effects depending on gender, new research shows.

Investigators found childhood emotional and sexual abuse had a greater effect on women than men, whereas men were more adversely affected by emotional and physical neglect.

“Our findings indicate that exposure to childhood maltreatment increases the risk of having psychiatric symptoms in both men and women,” lead researcher Thanavadee Prachason, PhD, department of psychiatry and neuropsychology, Maastricht (the Netherlands) University Medical Center, said in a press release.

“Exposure to emotionally or sexually abusive experiences during childhood increases the risk of a variety of psychiatric symptoms, particularly in women. In contrast, a history of emotional or physical neglect in childhood increases the risk of having psychiatric symptoms more in men,” Dr. Prachason added.

The findings were presented at the European Psychiatric Association 2023 Congress.

A leading mental illness risk factor

Study presenter Laura Fusar-Poli, MD, PhD, from the department of brain and behavioral sciences, University of Pavia (Italy), said that the differential impact of trauma subtypes in men and women indicate that both gender and the type of childhood adversity experienced need to be taken into account in future studies.

Dr. Fusar-Poli began by highlighting that 13%-36% of individuals have experienced some kind of childhood trauma, with 30% exposed to at least two types of trauma.

Trauma has been identified as a risk factor for a range of mental health problems.

“It is estimated that, worldwide, around one third of all psychiatric disorders are related to childhood trauma,” senior researcher Sinan Gülöksüz, MD, PhD, also from Maastricht University Medical Center, said in the release.

Consequently, “childhood trauma is a leading preventable risk factor for mental illness,” he added.

Previous research suggests the subtype of trauma has an impact on subsequent biological changes and clinical outcomes, and that there are gender differences in the effects of childhood trauma.

To investigate, the researchers examined data from TwinssCan, a Belgian cohort of twins and siblings aged 15-35 years without a diagnosis of pervasive mental disorders.

The study included 477 females and 314 males who had completed the Childhood Trauma Questionnaire–Short Form (CTQ) and the Symptom Checklist-90 SR (SCL-90) to determine exposure to childhood adversity and levels of psychopathology, respectively.

Results showed that total CTQ scores were significantly associated with total SCL-90 scores in both men and women, as well as with each of the nine symptom domains of the SCL-90 (P < .001 for all assessments). These included psychoticism, paranoid ideation, anxiety, depression, somatization, obsessive-compulsive, interpersonal sensitivity, hostility, and phobic anxiety.

There were no significant differences in the associations with total CTQ scores between men and women.

However, when the researchers examined trauma subtypes and psychopathology, clear gender differences emerged.

Investigators found a significant association between emotional abuse on the CTQ and total SCL-90 scores in both men (P < .023) and women (P < .001), but that the association was significantly stronger in women (P = .043).

Sexual abuse was significantly associated with total SCL-90 scores in women (P < .001), while emotional neglect and physical neglect were significantly associated with psychopathology scores in men (P = .026 and P < .001, respectively).

“Physical neglect may include experiences of not having enough to eat, wearing dirty clothes, not being taken care of, and not getting taken to the doctor when the person was growing up,” said Dr. Prachason.

“Emotional neglect may include childhood experiences like not feeling loved or important, and not feeling close to the family.”

In women, emotional abuse was significantly associated with all nine symptom domains of the SCL-90, while sexual abuse was associated with seven: psychoticism, paranoid ideation, anxiety, depression, somatization, obsessive-compulsive, and hostility.

Physical neglect, in men, was significantly associated with eight of the symptom domains (all but somatization), but emotional neglect was linked only to depression, Dr. Fusar-Poli reported.

“This study showed a very important consequence of childhood trauma, and not only in people with mental disorders. I would like to underline that this is a general population, composed of adolescents and young adults, which is the age in which the majority of mental disorders starts, Dr. Fusar-Poli said in an interview.

She emphasized that psychotic disorders are only a part of the “broad range” of conditions that may be related to childhood trauma, which “can have an impact on sub-threshold symptoms that can affect functioning and quality of life in the general population.”

Addressing the differential findings in men and women, Dr. Gülöksüz noted women may be more “vulnerable to childhood trauma than men” simply because “they are exposed to more sexual and emotional abuse.”

However, he said, this is “something that we really need understand,” as there is likely an underlying mechanism, “and not only a biological mechanism but probably a societal one.”

Dr. Gülöksüz noted there could also be differences between societies in terms of the impact of childhood trauma. “Our sample was from Belgium, but what would happen if we conducted this study in Italy, or in India,” he said.

Compromised cognitive, emotional function

Commenting on the findings for this news organization, Elaine F. Walker, PhD, professor of psychology and neuroscience at Emory University in Atlanta, said stress exposure in general, including childhood trauma, “has transdiagnostic effects on vulnerability to mental disorders.”

“The effects are primarily mediated by the hypothalamic-pituitary-adrenal axis, which triggers the release of cortisol. When persistently elevated, this can result in neurobiological processes that have adverse effects on brain structure and circuitry which, in turn, compromises cognitive and emotional functioning,” said Dr. Walker, who was not associated with the study.

She noted that, “while it is possible that there are sex differences in biological sensitivity to certain subtypes of childhood trauma, it may also be the case that sex differences in the likelihood of exposure to trauma subtypes is actually the key factor.”

“At the present time, there are not specific treatment protocols aimed at addressing childhood trauma subtypes, but most experienced therapists will incorporate information about the individual’s trauma history in their treatment,” Dr. Walker added.

Also commenting on the research, Philip Gorwood, MD, PhD, head of the Clinique des Maladies Mentales et de l’Encéphale at Centre Hospitalier Sainte Anne in Paris, said the results are “important … as childhood trauma has been clearly recognized as a major risk factor for the vast majority of psychiatric disorders, but with poor knowledge of gender specificities.”

“Understanding which aspects of trauma are more damaging according to gender will facilitate research on the resilience process. Many intervention strategies will indeed benefit from a more personalized approach,” he said in a statement. Dr. Gorwood was not involved with this study.

The study authors, Dr. Gorwood, and Dr. Walker report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

PARIS – Childhood trauma affects women and men equally in terms of its impact on subsequent psychopathology, but trauma type has subsequent differential effects depending on gender, new research shows.

Investigators found childhood emotional and sexual abuse had a greater effect on women than men, whereas men were more adversely affected by emotional and physical neglect.

“Our findings indicate that exposure to childhood maltreatment increases the risk of having psychiatric symptoms in both men and women,” lead researcher Thanavadee Prachason, PhD, department of psychiatry and neuropsychology, Maastricht (the Netherlands) University Medical Center, said in a press release.

“Exposure to emotionally or sexually abusive experiences during childhood increases the risk of a variety of psychiatric symptoms, particularly in women. In contrast, a history of emotional or physical neglect in childhood increases the risk of having psychiatric symptoms more in men,” Dr. Prachason added.

The findings were presented at the European Psychiatric Association 2023 Congress.

A leading mental illness risk factor

Study presenter Laura Fusar-Poli, MD, PhD, from the department of brain and behavioral sciences, University of Pavia (Italy), said that the differential impact of trauma subtypes in men and women indicate that both gender and the type of childhood adversity experienced need to be taken into account in future studies.

Dr. Fusar-Poli began by highlighting that 13%-36% of individuals have experienced some kind of childhood trauma, with 30% exposed to at least two types of trauma.

Trauma has been identified as a risk factor for a range of mental health problems.

“It is estimated that, worldwide, around one third of all psychiatric disorders are related to childhood trauma,” senior researcher Sinan Gülöksüz, MD, PhD, also from Maastricht University Medical Center, said in the release.

Consequently, “childhood trauma is a leading preventable risk factor for mental illness,” he added.

Previous research suggests the subtype of trauma has an impact on subsequent biological changes and clinical outcomes, and that there are gender differences in the effects of childhood trauma.

To investigate, the researchers examined data from TwinssCan, a Belgian cohort of twins and siblings aged 15-35 years without a diagnosis of pervasive mental disorders.

The study included 477 females and 314 males who had completed the Childhood Trauma Questionnaire–Short Form (CTQ) and the Symptom Checklist-90 SR (SCL-90) to determine exposure to childhood adversity and levels of psychopathology, respectively.

Results showed that total CTQ scores were significantly associated with total SCL-90 scores in both men and women, as well as with each of the nine symptom domains of the SCL-90 (P < .001 for all assessments). These included psychoticism, paranoid ideation, anxiety, depression, somatization, obsessive-compulsive, interpersonal sensitivity, hostility, and phobic anxiety.

There were no significant differences in the associations with total CTQ scores between men and women.

However, when the researchers examined trauma subtypes and psychopathology, clear gender differences emerged.

Investigators found a significant association between emotional abuse on the CTQ and total SCL-90 scores in both men (P < .023) and women (P < .001), but that the association was significantly stronger in women (P = .043).

Sexual abuse was significantly associated with total SCL-90 scores in women (P < .001), while emotional neglect and physical neglect were significantly associated with psychopathology scores in men (P = .026 and P < .001, respectively).

“Physical neglect may include experiences of not having enough to eat, wearing dirty clothes, not being taken care of, and not getting taken to the doctor when the person was growing up,” said Dr. Prachason.

“Emotional neglect may include childhood experiences like not feeling loved or important, and not feeling close to the family.”

In women, emotional abuse was significantly associated with all nine symptom domains of the SCL-90, while sexual abuse was associated with seven: psychoticism, paranoid ideation, anxiety, depression, somatization, obsessive-compulsive, and hostility.

Physical neglect, in men, was significantly associated with eight of the symptom domains (all but somatization), but emotional neglect was linked only to depression, Dr. Fusar-Poli reported.

“This study showed a very important consequence of childhood trauma, and not only in people with mental disorders. I would like to underline that this is a general population, composed of adolescents and young adults, which is the age in which the majority of mental disorders starts, Dr. Fusar-Poli said in an interview.

She emphasized that psychotic disorders are only a part of the “broad range” of conditions that may be related to childhood trauma, which “can have an impact on sub-threshold symptoms that can affect functioning and quality of life in the general population.”

Addressing the differential findings in men and women, Dr. Gülöksüz noted women may be more “vulnerable to childhood trauma than men” simply because “they are exposed to more sexual and emotional abuse.”

However, he said, this is “something that we really need understand,” as there is likely an underlying mechanism, “and not only a biological mechanism but probably a societal one.”

Dr. Gülöksüz noted there could also be differences between societies in terms of the impact of childhood trauma. “Our sample was from Belgium, but what would happen if we conducted this study in Italy, or in India,” he said.

Compromised cognitive, emotional function

Commenting on the findings for this news organization, Elaine F. Walker, PhD, professor of psychology and neuroscience at Emory University in Atlanta, said stress exposure in general, including childhood trauma, “has transdiagnostic effects on vulnerability to mental disorders.”

“The effects are primarily mediated by the hypothalamic-pituitary-adrenal axis, which triggers the release of cortisol. When persistently elevated, this can result in neurobiological processes that have adverse effects on brain structure and circuitry which, in turn, compromises cognitive and emotional functioning,” said Dr. Walker, who was not associated with the study.

She noted that, “while it is possible that there are sex differences in biological sensitivity to certain subtypes of childhood trauma, it may also be the case that sex differences in the likelihood of exposure to trauma subtypes is actually the key factor.”

“At the present time, there are not specific treatment protocols aimed at addressing childhood trauma subtypes, but most experienced therapists will incorporate information about the individual’s trauma history in their treatment,” Dr. Walker added.

Also commenting on the research, Philip Gorwood, MD, PhD, head of the Clinique des Maladies Mentales et de l’Encéphale at Centre Hospitalier Sainte Anne in Paris, said the results are “important … as childhood trauma has been clearly recognized as a major risk factor for the vast majority of psychiatric disorders, but with poor knowledge of gender specificities.”

“Understanding which aspects of trauma are more damaging according to gender will facilitate research on the resilience process. Many intervention strategies will indeed benefit from a more personalized approach,” he said in a statement. Dr. Gorwood was not involved with this study.

The study authors, Dr. Gorwood, and Dr. Walker report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

PARIS – Childhood trauma affects women and men equally in terms of its impact on subsequent psychopathology, but trauma type has subsequent differential effects depending on gender, new research shows.

Investigators found childhood emotional and sexual abuse had a greater effect on women than men, whereas men were more adversely affected by emotional and physical neglect.

“Our findings indicate that exposure to childhood maltreatment increases the risk of having psychiatric symptoms in both men and women,” lead researcher Thanavadee Prachason, PhD, department of psychiatry and neuropsychology, Maastricht (the Netherlands) University Medical Center, said in a press release.

“Exposure to emotionally or sexually abusive experiences during childhood increases the risk of a variety of psychiatric symptoms, particularly in women. In contrast, a history of emotional or physical neglect in childhood increases the risk of having psychiatric symptoms more in men,” Dr. Prachason added.

The findings were presented at the European Psychiatric Association 2023 Congress.

A leading mental illness risk factor

Study presenter Laura Fusar-Poli, MD, PhD, from the department of brain and behavioral sciences, University of Pavia (Italy), said that the differential impact of trauma subtypes in men and women indicate that both gender and the type of childhood adversity experienced need to be taken into account in future studies.

Dr. Fusar-Poli began by highlighting that 13%-36% of individuals have experienced some kind of childhood trauma, with 30% exposed to at least two types of trauma.

Trauma has been identified as a risk factor for a range of mental health problems.

“It is estimated that, worldwide, around one third of all psychiatric disorders are related to childhood trauma,” senior researcher Sinan Gülöksüz, MD, PhD, also from Maastricht University Medical Center, said in the release.

Consequently, “childhood trauma is a leading preventable risk factor for mental illness,” he added.

Previous research suggests the subtype of trauma has an impact on subsequent biological changes and clinical outcomes, and that there are gender differences in the effects of childhood trauma.

To investigate, the researchers examined data from TwinssCan, a Belgian cohort of twins and siblings aged 15-35 years without a diagnosis of pervasive mental disorders.

The study included 477 females and 314 males who had completed the Childhood Trauma Questionnaire–Short Form (CTQ) and the Symptom Checklist-90 SR (SCL-90) to determine exposure to childhood adversity and levels of psychopathology, respectively.

Results showed that total CTQ scores were significantly associated with total SCL-90 scores in both men and women, as well as with each of the nine symptom domains of the SCL-90 (P < .001 for all assessments). These included psychoticism, paranoid ideation, anxiety, depression, somatization, obsessive-compulsive, interpersonal sensitivity, hostility, and phobic anxiety.

There were no significant differences in the associations with total CTQ scores between men and women.

However, when the researchers examined trauma subtypes and psychopathology, clear gender differences emerged.

Investigators found a significant association between emotional abuse on the CTQ and total SCL-90 scores in both men (P < .023) and women (P < .001), but that the association was significantly stronger in women (P = .043).

Sexual abuse was significantly associated with total SCL-90 scores in women (P < .001), while emotional neglect and physical neglect were significantly associated with psychopathology scores in men (P = .026 and P < .001, respectively).

“Physical neglect may include experiences of not having enough to eat, wearing dirty clothes, not being taken care of, and not getting taken to the doctor when the person was growing up,” said Dr. Prachason.

“Emotional neglect may include childhood experiences like not feeling loved or important, and not feeling close to the family.”

In women, emotional abuse was significantly associated with all nine symptom domains of the SCL-90, while sexual abuse was associated with seven: psychoticism, paranoid ideation, anxiety, depression, somatization, obsessive-compulsive, and hostility.

Physical neglect, in men, was significantly associated with eight of the symptom domains (all but somatization), but emotional neglect was linked only to depression, Dr. Fusar-Poli reported.

“This study showed a very important consequence of childhood trauma, and not only in people with mental disorders. I would like to underline that this is a general population, composed of adolescents and young adults, which is the age in which the majority of mental disorders starts, Dr. Fusar-Poli said in an interview.

She emphasized that psychotic disorders are only a part of the “broad range” of conditions that may be related to childhood trauma, which “can have an impact on sub-threshold symptoms that can affect functioning and quality of life in the general population.”

Addressing the differential findings in men and women, Dr. Gülöksüz noted women may be more “vulnerable to childhood trauma than men” simply because “they are exposed to more sexual and emotional abuse.”

However, he said, this is “something that we really need understand,” as there is likely an underlying mechanism, “and not only a biological mechanism but probably a societal one.”

Dr. Gülöksüz noted there could also be differences between societies in terms of the impact of childhood trauma. “Our sample was from Belgium, but what would happen if we conducted this study in Italy, or in India,” he said.

Compromised cognitive, emotional function

Commenting on the findings for this news organization, Elaine F. Walker, PhD, professor of psychology and neuroscience at Emory University in Atlanta, said stress exposure in general, including childhood trauma, “has transdiagnostic effects on vulnerability to mental disorders.”

“The effects are primarily mediated by the hypothalamic-pituitary-adrenal axis, which triggers the release of cortisol. When persistently elevated, this can result in neurobiological processes that have adverse effects on brain structure and circuitry which, in turn, compromises cognitive and emotional functioning,” said Dr. Walker, who was not associated with the study.

She noted that, “while it is possible that there are sex differences in biological sensitivity to certain subtypes of childhood trauma, it may also be the case that sex differences in the likelihood of exposure to trauma subtypes is actually the key factor.”

“At the present time, there are not specific treatment protocols aimed at addressing childhood trauma subtypes, but most experienced therapists will incorporate information about the individual’s trauma history in their treatment,” Dr. Walker added.

Also commenting on the research, Philip Gorwood, MD, PhD, head of the Clinique des Maladies Mentales et de l’Encéphale at Centre Hospitalier Sainte Anne in Paris, said the results are “important … as childhood trauma has been clearly recognized as a major risk factor for the vast majority of psychiatric disorders, but with poor knowledge of gender specificities.”

“Understanding which aspects of trauma are more damaging according to gender will facilitate research on the resilience process. Many intervention strategies will indeed benefit from a more personalized approach,” he said in a statement. Dr. Gorwood was not involved with this study.

The study authors, Dr. Gorwood, and Dr. Walker report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

It’s possible to flag suicide risk by automatically extracting clinical notes on social determinants of health (SDOH) from a patient’s electronic health record using natural language processing (NLP), a form of artificial intelligence, new research shows.

Researchers found SDOH are risk factors for suicide among U.S. veterans and NLP can be leveraged to extract SDOH information from unstructured data in the EHR.

“Since SDOH is overwhelmingly described in EHR notes, the importance of NLP-extracted SDOH can be very significant, meaning that NLP can be used as an effective method for epidemiological and public health study,” senior investigator Hong Yu, PhD, from Miner School of Information and Computer Sciences, University of Massachusetts Lowell, told this news organization.

Although the study was conducted among U.S. veterans, the results likely hold for the general population as well.

“The NLP methods are generalizable. The SDOH categories are generalizable. There may be some variations in terms of the strength of associations in NLP-extracted SDOH and suicide death, but the overall findings are generalizable,” Dr. Yu said.

The study was published online JAMA Network Open.
 

Improved risk assessment

SDOH, which include factors such as socioeconomic status, access to healthy food, education, housing, and physical environment, are strong predictors of suicidal behaviors.

Several studies have identified a range of common risk factors for suicide using International Classification of Diseases (ICD) codes and other “structured” data from the EHR.  However, the use of unstructured EHR data from clinician notes has received little attention in investigating potential associations between suicide and SDOH.

Using the large Veterans Health Administration EHR system, the researchers determined associations between veterans’ death by suicide and recent SDOH, identified using both structured data (ICD-10 codes and Veterans Health Administration stop codes) and unstructured data (NLP-processed clinical notes).

Participants included 8,821 veterans who committed suicide and 35,284 matched controls. The cohort was mostly male (96%) and White (79%). The mean age was 58 years.

The NLP-extracted SDOH were social isolation, job or financial insecurity, housing instability, legal problems, violence, barriers to care, transition of care, and food insecurity.

All of these unstructured clinical notes on SDOH were significantly associated with increased risk for death by suicide.

Legal problems had the largest estimated effect size, more than twice the risk of those with no exposure (adjusted odds ratio 2.62; 95% confidence interval, 2.38-2.89), followed by violence (aOR, 2.34; 95% CI, 2.17-2.52) and social isolation (aOR, 1.94; 95% CI, 1.83-2.06).

Similarly, all of the structured SDOH – social or family problems, employment or financial problems, housing instability, legal problems, violence, and nonspecific psychosocial needs – also showed significant associations with increased risk for suicide death, once again, with legal problems linked to the highest risk (aOR, 2.63; 95% CI, 2.37-2.91).

When combining the structured and NLP-extracted unstructured data, the top three risk factors for death by suicide were legal problems (aOR, 2.66; 95% CI 2.46-2.89), violence (aOR, 2.12; 95% CI, 1.98-2.27), and nonspecific psychosocial needs (aOR, 2.07; 95% CI, 1.92-2.23).

“To our knowledge, this the first large-scale study to implement and use an NLP system to extract SDOH information from unstructured EHR data,” the researchers write.

“We strongly believe that analyzing all available SDOH information, including those contained in clinical notes, can help develop a better system for risk assessment and suicide prevention. However, more studies are required to investigate ways of seamlessly incorporating SDOHs into existing health care systems,” they conclude.

Dr. Yu said it’s also important to note that their NLP system is built upon “the most advanced deep-learning technologies and therefore is more generalizable than most existing work that mainly used rule-based approaches or traditional machine learning for identifying social determinants of health.”

In an accompanying editorial, Ishanu Chattopadhyay, PhD, of the University of Chicago, said this suggests that unstructured clinical notes “may efficiently identify at-risk individuals even when structured data on the relevant variables are missing or incomplete.”

This work may provide “the foundation for addressing the key hurdles in enacting efficient universal assessment for suicide risk among the veterans and perhaps in the general population,” Dr. Chattopadhyay added.

This research was funded by a grant from the National Institute of Mental Health. The study authors and editorialist report no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

It’s possible to flag suicide risk by automatically extracting clinical notes on social determinants of health (SDOH) from a patient’s electronic health record using natural language processing (NLP), a form of artificial intelligence, new research shows.

Researchers found SDOH are risk factors for suicide among U.S. veterans and NLP can be leveraged to extract SDOH information from unstructured data in the EHR.

“Since SDOH is overwhelmingly described in EHR notes, the importance of NLP-extracted SDOH can be very significant, meaning that NLP can be used as an effective method for epidemiological and public health study,” senior investigator Hong Yu, PhD, from Miner School of Information and Computer Sciences, University of Massachusetts Lowell, told this news organization.

Although the study was conducted among U.S. veterans, the results likely hold for the general population as well.

“The NLP methods are generalizable. The SDOH categories are generalizable. There may be some variations in terms of the strength of associations in NLP-extracted SDOH and suicide death, but the overall findings are generalizable,” Dr. Yu said.

The study was published online JAMA Network Open.
 

Improved risk assessment

SDOH, which include factors such as socioeconomic status, access to healthy food, education, housing, and physical environment, are strong predictors of suicidal behaviors.

Several studies have identified a range of common risk factors for suicide using International Classification of Diseases (ICD) codes and other “structured” data from the EHR.  However, the use of unstructured EHR data from clinician notes has received little attention in investigating potential associations between suicide and SDOH.

Using the large Veterans Health Administration EHR system, the researchers determined associations between veterans’ death by suicide and recent SDOH, identified using both structured data (ICD-10 codes and Veterans Health Administration stop codes) and unstructured data (NLP-processed clinical notes).

Participants included 8,821 veterans who committed suicide and 35,284 matched controls. The cohort was mostly male (96%) and White (79%). The mean age was 58 years.

The NLP-extracted SDOH were social isolation, job or financial insecurity, housing instability, legal problems, violence, barriers to care, transition of care, and food insecurity.

All of these unstructured clinical notes on SDOH were significantly associated with increased risk for death by suicide.

Legal problems had the largest estimated effect size, more than twice the risk of those with no exposure (adjusted odds ratio 2.62; 95% confidence interval, 2.38-2.89), followed by violence (aOR, 2.34; 95% CI, 2.17-2.52) and social isolation (aOR, 1.94; 95% CI, 1.83-2.06).

Similarly, all of the structured SDOH – social or family problems, employment or financial problems, housing instability, legal problems, violence, and nonspecific psychosocial needs – also showed significant associations with increased risk for suicide death, once again, with legal problems linked to the highest risk (aOR, 2.63; 95% CI, 2.37-2.91).

When combining the structured and NLP-extracted unstructured data, the top three risk factors for death by suicide were legal problems (aOR, 2.66; 95% CI 2.46-2.89), violence (aOR, 2.12; 95% CI, 1.98-2.27), and nonspecific psychosocial needs (aOR, 2.07; 95% CI, 1.92-2.23).

“To our knowledge, this the first large-scale study to implement and use an NLP system to extract SDOH information from unstructured EHR data,” the researchers write.

“We strongly believe that analyzing all available SDOH information, including those contained in clinical notes, can help develop a better system for risk assessment and suicide prevention. However, more studies are required to investigate ways of seamlessly incorporating SDOHs into existing health care systems,” they conclude.

Dr. Yu said it’s also important to note that their NLP system is built upon “the most advanced deep-learning technologies and therefore is more generalizable than most existing work that mainly used rule-based approaches or traditional machine learning for identifying social determinants of health.”

In an accompanying editorial, Ishanu Chattopadhyay, PhD, of the University of Chicago, said this suggests that unstructured clinical notes “may efficiently identify at-risk individuals even when structured data on the relevant variables are missing or incomplete.”

This work may provide “the foundation for addressing the key hurdles in enacting efficient universal assessment for suicide risk among the veterans and perhaps in the general population,” Dr. Chattopadhyay added.

This research was funded by a grant from the National Institute of Mental Health. The study authors and editorialist report no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

It’s possible to flag suicide risk by automatically extracting clinical notes on social determinants of health (SDOH) from a patient’s electronic health record using natural language processing (NLP), a form of artificial intelligence, new research shows.

Researchers found SDOH are risk factors for suicide among U.S. veterans and NLP can be leveraged to extract SDOH information from unstructured data in the EHR.

“Since SDOH is overwhelmingly described in EHR notes, the importance of NLP-extracted SDOH can be very significant, meaning that NLP can be used as an effective method for epidemiological and public health study,” senior investigator Hong Yu, PhD, from Miner School of Information and Computer Sciences, University of Massachusetts Lowell, told this news organization.

Although the study was conducted among U.S. veterans, the results likely hold for the general population as well.

“The NLP methods are generalizable. The SDOH categories are generalizable. There may be some variations in terms of the strength of associations in NLP-extracted SDOH and suicide death, but the overall findings are generalizable,” Dr. Yu said.

The study was published online JAMA Network Open.
 

Improved risk assessment

SDOH, which include factors such as socioeconomic status, access to healthy food, education, housing, and physical environment, are strong predictors of suicidal behaviors.

Several studies have identified a range of common risk factors for suicide using International Classification of Diseases (ICD) codes and other “structured” data from the EHR.  However, the use of unstructured EHR data from clinician notes has received little attention in investigating potential associations between suicide and SDOH.

Using the large Veterans Health Administration EHR system, the researchers determined associations between veterans’ death by suicide and recent SDOH, identified using both structured data (ICD-10 codes and Veterans Health Administration stop codes) and unstructured data (NLP-processed clinical notes).

Participants included 8,821 veterans who committed suicide and 35,284 matched controls. The cohort was mostly male (96%) and White (79%). The mean age was 58 years.

The NLP-extracted SDOH were social isolation, job or financial insecurity, housing instability, legal problems, violence, barriers to care, transition of care, and food insecurity.

All of these unstructured clinical notes on SDOH were significantly associated with increased risk for death by suicide.

Legal problems had the largest estimated effect size, more than twice the risk of those with no exposure (adjusted odds ratio 2.62; 95% confidence interval, 2.38-2.89), followed by violence (aOR, 2.34; 95% CI, 2.17-2.52) and social isolation (aOR, 1.94; 95% CI, 1.83-2.06).

Similarly, all of the structured SDOH – social or family problems, employment or financial problems, housing instability, legal problems, violence, and nonspecific psychosocial needs – also showed significant associations with increased risk for suicide death, once again, with legal problems linked to the highest risk (aOR, 2.63; 95% CI, 2.37-2.91).

When combining the structured and NLP-extracted unstructured data, the top three risk factors for death by suicide were legal problems (aOR, 2.66; 95% CI 2.46-2.89), violence (aOR, 2.12; 95% CI, 1.98-2.27), and nonspecific psychosocial needs (aOR, 2.07; 95% CI, 1.92-2.23).

“To our knowledge, this the first large-scale study to implement and use an NLP system to extract SDOH information from unstructured EHR data,” the researchers write.

“We strongly believe that analyzing all available SDOH information, including those contained in clinical notes, can help develop a better system for risk assessment and suicide prevention. However, more studies are required to investigate ways of seamlessly incorporating SDOHs into existing health care systems,” they conclude.

Dr. Yu said it’s also important to note that their NLP system is built upon “the most advanced deep-learning technologies and therefore is more generalizable than most existing work that mainly used rule-based approaches or traditional machine learning for identifying social determinants of health.”

In an accompanying editorial, Ishanu Chattopadhyay, PhD, of the University of Chicago, said this suggests that unstructured clinical notes “may efficiently identify at-risk individuals even when structured data on the relevant variables are missing or incomplete.”

This work may provide “the foundation for addressing the key hurdles in enacting efficient universal assessment for suicide risk among the veterans and perhaps in the general population,” Dr. Chattopadhyay added.

This research was funded by a grant from the National Institute of Mental Health. The study authors and editorialist report no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

For as long as I can remember, psychiatrists have talked about what the appropriate boundaries are for self-disclosure about personal issues with patients. There is obviously no exact answer as to what is acceptable to disclose; this depends on the doctor, the patient, the “brand” of psychotherapy, the patient’s issues, the nature of what is being disclosed, and maybe the alignment of the stars on that particular day. “Stutz,” the Netflix documentary that Oscar-nominated actor/director Jonah Hill has made about his psychiatrist, Phil Stutz, MD, adds a whole new chapter to the discussion.

“Okay, entertain me,” Dr. Stutz says as his patient takes a seat. The therapeutic relationship and the paradigm Dr. Stutz has created to help his patients has been healing for Jonah Hill. The very serious and intimate dialogue that follows unfolds with moments of humor, warmth, and open affection. Hill candidly tells us why he is making this documentary – to share what he has learned and to honor his therapist – but we don’t know why Dr. Stutz has agreed to the endeavor and we’re left to our own inferences.

Dr. Stutz is the coauthor, with Barry Michels, of a best-selling self-help book, “The Tools: 5 Tools to Help You Find Courage, Creativity, and Willpower – and Inspire You to Live Life in Forward Motion.” He talks about his restlessness with the psychodynamic method during his training as a resident in New York – he wanted to offer his patients more immediate relief and a supervisor told him, “Don’t you dare!”

In the film, he talks about giving patients hope and direction. And Hill makes the comment, “In traditional therapy, you’re paying this person and you save all your problems for them, and they just listen, and your friends – who are idiots – give you advice, unsolicited, and you want your friends just to listen, and you want your therapist to give you advice!” Dr. Stutz gives advice and he is like no other therapist Jonah has ever had.

The premise of the film is that we are watching a single therapy session and Dr. Stutz will discuss the use of his tools and techniques that Hill has found helpful. Jonah is the interviewer, and when the doctor suggests it would be helpful if Jonah talked about his life, the patient/director rebuffs him; this documentary is about the psychiatrist.

Early in the film an alarm goes off, Dr. Stutz does not hear it, and Jonah has to remind him that it’s time for him to take his pills. The psychiatrist has Parkinson’s disease and how it has affected him becomes one focal point for the film. We later learn that he lost a younger brother as a child (something Hill did not know before they started filming) and grew up in the shadow of that loss. His extroverted father made it clear that medicine was the only acceptable career path for his son, and his introverted and depressed mother spent her days proclaiming that all men were as awful as her own abusive father.

About a third of the way through the film, the focus shifts. Jonah suddenly confesses that he is feeling stuck with regard to the movie, that he is troubled by the fact that he has not been able to share his distress with Dr. Stutz during their real-life, unfilmed therapy sessions, and the viewers learn that the single-session concept was disingenuous – they have been filming this documentary for two years, against a green screen and not in an office, always wearing the same clothes, and Jonah pulls off a wig that he wears to disguise the fact that he changed his hairstyle months earlier.

It’s a bit unnerving as they throw the wig around, and Jonah agrees to be more open about the issues he has struggled with. He acknowledges that this has been difficult, and he says, “I just keep asking myself, like, was this a f***ing horrible idea for a patient to make a movie about his therapist?” From my perspective as a psychiatrist-viewer, it’s a good question to ask!

Dr. Stutz reassures Jonah that it is okay to be vulnerable. “Failure, weakness, vulnerability – it’s like a connector, it connects you to the rest of the world.” A super-sized cardboard cutout of an obese 14-year-old Jonah now joins the room, and we learn that he continues to struggle with his self-image. Things get more real.

Peppered throughout the film, there are lessons from Dr. Stutz about his “tools,” constructs he uses to help people restructure their worlds and take action to move forward. One such construct he calls “the maze,” which occurs when one person in an interpersonal relationship is waiting for fairness and becomes preoccupied with feeling injured.

Jonah inquires about Dr. Stutz’s romantic life and the therapist replies with a transparency that overrides our usual professional boundaries. We all learn that Dr. Stutz is not in a relationship, he’s never been married, but there is a woman he has had some involvement with on and off for 40 years. Jonah’s line of questioning rivals that of any therapist. “How do you think it affects you, having your mom hate men and you being a man?” Dr. Stutz admits that he can never feel safe with women. “Did you ever override that wall you built with your mom and get close to a woman?” When Jonah professes, “I don’t feel anything but love for you and I just want you to be happy,” my own feeling was that the tables had turned too far, that the therapist’s failed romantic life risked being a burden to the patient.

Still, there is something about the relationship between the two men that is touching and beautiful. Dr. Stutz as a therapist is charismatic, caring, self-assured, and optimistic, and he radiates hope and certainty. He mixes an intense intimacy with humor in a way that is both authentic and entertaining. The interspersed jokes break the intensity, but they don’t diminish his wisdom and the healing he imparts.

Dr. Stutz is a psychiatrist, and his strength is clearly as a psychotherapist, yet there is not a single mention of psychotropic medications – there is a banter about recreational drugs and medications for Parkinson’s disease. If Hill is taking medication for depression or anxiety, and if prescribing is part of Dr. Stutz’s arsenal, the viewer is not made aware of this.

Dr. Stutz eschews the slow, detached, and “neutral” pace of psychodynamic therapy and the whole concept of the therapist as a blank wall for the transference to play out on, but here the transference screams: Jonah loves him, he respect and honors him, he wants him to be happy, and he is afraid of losing him.

“Stutz” is a movie about a larger-than-life psychiatrist, one whose warmth and inspiration are healing. I imagine his tools are helpful, but his personality is what carries the load. If a viewer has not had experience with psychiatry, and this film inspires him to begin therapy, there may be a good deal of disappointment. In this case, the patient is a successful actor, and one might wonder if that, together with the entire years-long project of filming, has altered the relationship well beyond the usual therapeutic hour.

Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University in Baltimore.

For as long as I can remember, psychiatrists have talked about what the appropriate boundaries are for self-disclosure about personal issues with patients. There is obviously no exact answer as to what is acceptable to disclose; this depends on the doctor, the patient, the “brand” of psychotherapy, the patient’s issues, the nature of what is being disclosed, and maybe the alignment of the stars on that particular day. “Stutz,” the Netflix documentary that Oscar-nominated actor/director Jonah Hill has made about his psychiatrist, Phil Stutz, MD, adds a whole new chapter to the discussion.

“Okay, entertain me,” Dr. Stutz says as his patient takes a seat. The therapeutic relationship and the paradigm Dr. Stutz has created to help his patients has been healing for Jonah Hill. The very serious and intimate dialogue that follows unfolds with moments of humor, warmth, and open affection. Hill candidly tells us why he is making this documentary – to share what he has learned and to honor his therapist – but we don’t know why Dr. Stutz has agreed to the endeavor and we’re left to our own inferences.

Dr. Stutz is the coauthor, with Barry Michels, of a best-selling self-help book, “The Tools: 5 Tools to Help You Find Courage, Creativity, and Willpower – and Inspire You to Live Life in Forward Motion.” He talks about his restlessness with the psychodynamic method during his training as a resident in New York – he wanted to offer his patients more immediate relief and a supervisor told him, “Don’t you dare!”

In the film, he talks about giving patients hope and direction. And Hill makes the comment, “In traditional therapy, you’re paying this person and you save all your problems for them, and they just listen, and your friends – who are idiots – give you advice, unsolicited, and you want your friends just to listen, and you want your therapist to give you advice!” Dr. Stutz gives advice and he is like no other therapist Jonah has ever had.

The premise of the film is that we are watching a single therapy session and Dr. Stutz will discuss the use of his tools and techniques that Hill has found helpful. Jonah is the interviewer, and when the doctor suggests it would be helpful if Jonah talked about his life, the patient/director rebuffs him; this documentary is about the psychiatrist.

Early in the film an alarm goes off, Dr. Stutz does not hear it, and Jonah has to remind him that it’s time for him to take his pills. The psychiatrist has Parkinson’s disease and how it has affected him becomes one focal point for the film. We later learn that he lost a younger brother as a child (something Hill did not know before they started filming) and grew up in the shadow of that loss. His extroverted father made it clear that medicine was the only acceptable career path for his son, and his introverted and depressed mother spent her days proclaiming that all men were as awful as her own abusive father.

About a third of the way through the film, the focus shifts. Jonah suddenly confesses that he is feeling stuck with regard to the movie, that he is troubled by the fact that he has not been able to share his distress with Dr. Stutz during their real-life, unfilmed therapy sessions, and the viewers learn that the single-session concept was disingenuous – they have been filming this documentary for two years, against a green screen and not in an office, always wearing the same clothes, and Jonah pulls off a wig that he wears to disguise the fact that he changed his hairstyle months earlier.

It’s a bit unnerving as they throw the wig around, and Jonah agrees to be more open about the issues he has struggled with. He acknowledges that this has been difficult, and he says, “I just keep asking myself, like, was this a f***ing horrible idea for a patient to make a movie about his therapist?” From my perspective as a psychiatrist-viewer, it’s a good question to ask!

Dr. Stutz reassures Jonah that it is okay to be vulnerable. “Failure, weakness, vulnerability – it’s like a connector, it connects you to the rest of the world.” A super-sized cardboard cutout of an obese 14-year-old Jonah now joins the room, and we learn that he continues to struggle with his self-image. Things get more real.

Peppered throughout the film, there are lessons from Dr. Stutz about his “tools,” constructs he uses to help people restructure their worlds and take action to move forward. One such construct he calls “the maze,” which occurs when one person in an interpersonal relationship is waiting for fairness and becomes preoccupied with feeling injured.

Jonah inquires about Dr. Stutz’s romantic life and the therapist replies with a transparency that overrides our usual professional boundaries. We all learn that Dr. Stutz is not in a relationship, he’s never been married, but there is a woman he has had some involvement with on and off for 40 years. Jonah’s line of questioning rivals that of any therapist. “How do you think it affects you, having your mom hate men and you being a man?” Dr. Stutz admits that he can never feel safe with women. “Did you ever override that wall you built with your mom and get close to a woman?” When Jonah professes, “I don’t feel anything but love for you and I just want you to be happy,” my own feeling was that the tables had turned too far, that the therapist’s failed romantic life risked being a burden to the patient.

Still, there is something about the relationship between the two men that is touching and beautiful. Dr. Stutz as a therapist is charismatic, caring, self-assured, and optimistic, and he radiates hope and certainty. He mixes an intense intimacy with humor in a way that is both authentic and entertaining. The interspersed jokes break the intensity, but they don’t diminish his wisdom and the healing he imparts.

Dr. Stutz is a psychiatrist, and his strength is clearly as a psychotherapist, yet there is not a single mention of psychotropic medications – there is a banter about recreational drugs and medications for Parkinson’s disease. If Hill is taking medication for depression or anxiety, and if prescribing is part of Dr. Stutz’s arsenal, the viewer is not made aware of this.

Dr. Stutz eschews the slow, detached, and “neutral” pace of psychodynamic therapy and the whole concept of the therapist as a blank wall for the transference to play out on, but here the transference screams: Jonah loves him, he respect and honors him, he wants him to be happy, and he is afraid of losing him.

“Stutz” is a movie about a larger-than-life psychiatrist, one whose warmth and inspiration are healing. I imagine his tools are helpful, but his personality is what carries the load. If a viewer has not had experience with psychiatry, and this film inspires him to begin therapy, there may be a good deal of disappointment. In this case, the patient is a successful actor, and one might wonder if that, together with the entire years-long project of filming, has altered the relationship well beyond the usual therapeutic hour.

Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University in Baltimore.

For as long as I can remember, psychiatrists have talked about what the appropriate boundaries are for self-disclosure about personal issues with patients. There is obviously no exact answer as to what is acceptable to disclose; this depends on the doctor, the patient, the “brand” of psychotherapy, the patient’s issues, the nature of what is being disclosed, and maybe the alignment of the stars on that particular day. “Stutz,” the Netflix documentary that Oscar-nominated actor/director Jonah Hill has made about his psychiatrist, Phil Stutz, MD, adds a whole new chapter to the discussion.

“Okay, entertain me,” Dr. Stutz says as his patient takes a seat. The therapeutic relationship and the paradigm Dr. Stutz has created to help his patients has been healing for Jonah Hill. The very serious and intimate dialogue that follows unfolds with moments of humor, warmth, and open affection. Hill candidly tells us why he is making this documentary – to share what he has learned and to honor his therapist – but we don’t know why Dr. Stutz has agreed to the endeavor and we’re left to our own inferences.

Dr. Stutz is the coauthor, with Barry Michels, of a best-selling self-help book, “The Tools: 5 Tools to Help You Find Courage, Creativity, and Willpower – and Inspire You to Live Life in Forward Motion.” He talks about his restlessness with the psychodynamic method during his training as a resident in New York – he wanted to offer his patients more immediate relief and a supervisor told him, “Don’t you dare!”

In the film, he talks about giving patients hope and direction. And Hill makes the comment, “In traditional therapy, you’re paying this person and you save all your problems for them, and they just listen, and your friends – who are idiots – give you advice, unsolicited, and you want your friends just to listen, and you want your therapist to give you advice!” Dr. Stutz gives advice and he is like no other therapist Jonah has ever had.

The premise of the film is that we are watching a single therapy session and Dr. Stutz will discuss the use of his tools and techniques that Hill has found helpful. Jonah is the interviewer, and when the doctor suggests it would be helpful if Jonah talked about his life, the patient/director rebuffs him; this documentary is about the psychiatrist.

Early in the film an alarm goes off, Dr. Stutz does not hear it, and Jonah has to remind him that it’s time for him to take his pills. The psychiatrist has Parkinson’s disease and how it has affected him becomes one focal point for the film. We later learn that he lost a younger brother as a child (something Hill did not know before they started filming) and grew up in the shadow of that loss. His extroverted father made it clear that medicine was the only acceptable career path for his son, and his introverted and depressed mother spent her days proclaiming that all men were as awful as her own abusive father.

About a third of the way through the film, the focus shifts. Jonah suddenly confesses that he is feeling stuck with regard to the movie, that he is troubled by the fact that he has not been able to share his distress with Dr. Stutz during their real-life, unfilmed therapy sessions, and the viewers learn that the single-session concept was disingenuous – they have been filming this documentary for two years, against a green screen and not in an office, always wearing the same clothes, and Jonah pulls off a wig that he wears to disguise the fact that he changed his hairstyle months earlier.

It’s a bit unnerving as they throw the wig around, and Jonah agrees to be more open about the issues he has struggled with. He acknowledges that this has been difficult, and he says, “I just keep asking myself, like, was this a f***ing horrible idea for a patient to make a movie about his therapist?” From my perspective as a psychiatrist-viewer, it’s a good question to ask!

Dr. Stutz reassures Jonah that it is okay to be vulnerable. “Failure, weakness, vulnerability – it’s like a connector, it connects you to the rest of the world.” A super-sized cardboard cutout of an obese 14-year-old Jonah now joins the room, and we learn that he continues to struggle with his self-image. Things get more real.

Peppered throughout the film, there are lessons from Dr. Stutz about his “tools,” constructs he uses to help people restructure their worlds and take action to move forward. One such construct he calls “the maze,” which occurs when one person in an interpersonal relationship is waiting for fairness and becomes preoccupied with feeling injured.

Jonah inquires about Dr. Stutz’s romantic life and the therapist replies with a transparency that overrides our usual professional boundaries. We all learn that Dr. Stutz is not in a relationship, he’s never been married, but there is a woman he has had some involvement with on and off for 40 years. Jonah’s line of questioning rivals that of any therapist. “How do you think it affects you, having your mom hate men and you being a man?” Dr. Stutz admits that he can never feel safe with women. “Did you ever override that wall you built with your mom and get close to a woman?” When Jonah professes, “I don’t feel anything but love for you and I just want you to be happy,” my own feeling was that the tables had turned too far, that the therapist’s failed romantic life risked being a burden to the patient.

Still, there is something about the relationship between the two men that is touching and beautiful. Dr. Stutz as a therapist is charismatic, caring, self-assured, and optimistic, and he radiates hope and certainty. He mixes an intense intimacy with humor in a way that is both authentic and entertaining. The interspersed jokes break the intensity, but they don’t diminish his wisdom and the healing he imparts.

Dr. Stutz is a psychiatrist, and his strength is clearly as a psychotherapist, yet there is not a single mention of psychotropic medications – there is a banter about recreational drugs and medications for Parkinson’s disease. If Hill is taking medication for depression or anxiety, and if prescribing is part of Dr. Stutz’s arsenal, the viewer is not made aware of this.

Dr. Stutz eschews the slow, detached, and “neutral” pace of psychodynamic therapy and the whole concept of the therapist as a blank wall for the transference to play out on, but here the transference screams: Jonah loves him, he respect and honors him, he wants him to be happy, and he is afraid of losing him.

“Stutz” is a movie about a larger-than-life psychiatrist, one whose warmth and inspiration are healing. I imagine his tools are helpful, but his personality is what carries the load. If a viewer has not had experience with psychiatry, and this film inspires him to begin therapy, there may be a good deal of disappointment. In this case, the patient is a successful actor, and one might wonder if that, together with the entire years-long project of filming, has altered the relationship well beyond the usual therapeutic hour.

Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University in Baltimore.

The sleep aid melatonin is associated with a reduced risk of self-harm in adolescents with psychiatric disorders, new research suggests. However, at least one expert has some concerns about the strength of the evidence.

The results suggest improving sleep hygiene in this population may reduce self-injury, study investigator Sarah E. Bergen, PhD, associate professor, department of medical epidemiology and biostatistics, Karolinska Institute, Stockholm, said in an interview.

In addition, she noted, for “pediatric patients who are experiencing sleep problems, melatonin is a safe and effective way to help them.”

Dr. Bergen believes clinicians should recommend melatonin to all teens because “there’s little harm that could come from it and possibly a lot of benefit.”

The findings were published online in the Journal of Child Psychology and Psychiatry.
 

Few treatments available

Research shows sleep disorders like insomnia are common in youth, particularly among those with psychiatric disorders. Sleep disorders can significantly affect daytime functioning, cognition, emotional regulation, and behavior, and can be a risk factor for unintentional injuries such as falls and vehicular accidents, as well as for intentional self-harm.

The lifetime prevalence of self-harm in youth is estimated to be 17%, but this varies across study designs. There are few treatments for self-harm in youth, although psychosocial treatments appear promising.

Melatonin is a naturally occurring hormone secreted primarily by the pineal gland in response to darkness. It helps promote and maintain the normal sleep-wake cycle and is involved in other biological functions.

In Sweden, melatonin is the most commonly prescribed drug for sleep disturbances in children and adolescents. Prior to 2020, during the course of the study, it was only available by prescription.

The study, which used linked national databases, included 25,575 children and adolescents, 58.2% of them male, who initiated a melatonin treatment between the ages of 6 and 18 years.

Researchers estimated the risks of self-harm, including poisoning (57%) and cutting (34%). The fact that poisoning was more common than cutting was somewhat surprising, said Dr. Bergen. “I would have thought the opposite would be true; that cutting was more prevalent.”

The study examined the risk of self-harm in individual participants by comparing the last unmedicated month with the 12 months after initiating melatonin treatment. In this way, they accounted for potential confounders such as genetics, sleep disorder severity, and psychiatric disorders.

The median age at first melatonin prescription was 13 years for males and 15 years for females.

While there were no statistically significant changes in relative risk for body injuries, falls, and transport accidents, the relative risk for self-injury was statistically significantly lower during the months following melatonin treatment initiation.

The incidence rate ratio in the month following treatment was 0.58 (95% confidence interval, 0.46-0.73) for self-harm and 0.59 (95% CI, 0.45-0.78) for poisoning.
 

Higher risks in females

The relative risk of self-harm was higher in females than males. This, said Dr. Bergen, is possibly because self-harm is more common in adolescence than in childhood. Female study participants were older than their male counterparts.

Melatonin may help male teens, too, she said. “It’s just that the problem is not that great in males to begin with, so a decrease is not very dramatic after melatonin initiation.”

About 87.2% of participants treated with melatonin were diagnosed with at least one psychiatric disorder. Attention-deficit hyperactivity disorder, the most common comorbidity, was diagnosed in more than 50% of new melatonin users. This isn’t surprising, because sleep disturbances are associated with this psychiatric condition and are frequent side effects of ADHD medications.

After ADHD, anxiety and depression were the next most common psychiatric disorders among study subjects. The analysis found risks for self-harm and poisoning were largely driven by patients suffering from one or both of these disorders, particularly among females.

The IRR in the month following melatonin treatment initiation was 0.46 (95% CI, 0.27-0.76] among adolescent females with psychiatric disorders, after excluding antidepressant users.

Melatonin may reduce the risk of self-harm by treating sleep problems related to psychiatric comorbidities, especially anxiety and depression. It could also decrease pain sensitivity experienced by adolescents who self-harm.

Other factors could play a role in treating sleep problems and/or preventing self-harm in these patients. For example, increased clinician awareness and monitoring, behavioral interventions, a placebo effect, and concurrent use of other medications.

When researchers ran an analysis that excluded individuals taking an antidepressant, “surprisingly, there wasn’t much difference,” said Dr. Bergen. “We thought antidepressants might be causing some of the effect we observed, but when we removed antidepressant users, we saw a very similar pattern of intentional self-harm rates following melatonin use, which suggests melatonin is causal, but we can’t prove that.”

Other sleep medications such as sedatives could also affect self-harm rates by improving sleep. However, these are not typically prescribed to children because of their side effects and overdose potential, said Dr. Bergen.

“Melatonin is extremely safe and side effects are rare; it’s impossible to overdose, and people really can’t hurt themselves with it.”
 

More research needed

Adrian Jacques Ambrose, MD, medical director, Columbia University Irving Medical Center, and assistant professor of psychiatry, Columbia University, New York, pointed out some evidence in the study is relatively weak.

“When the authors separated out the on- and off-melatonin groups, it looks like there wasn’t a statistically significant difference [in IRRs] between the two groups – for example, in any injury, self-harm, or poisoning – and this weakens their argument that melatonin is associated with self-harm and poisoning.”

Given the current youth mental health crisis, more research “would absolutely be indicated” to better explore possible additional variables, said Dr. Ambrose.

“For example, some additional follow-up studies may add on covariates in conjunction with melatonin usage, such as the number of medical appointments, the presence of psychotherapeutic interventions, dosage of melatonin, or even the sleepiness scale, to evaluate whether the symptoms of sleep disturbances are more directly correlated with the self-harm behaviors.”

The study was supported by the European Union’s Horizon 2020 Research and Innovation Programme. Dr. Bergen and Dr. Ambrose report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The sleep aid melatonin is associated with a reduced risk of self-harm in adolescents with psychiatric disorders, new research suggests. However, at least one expert has some concerns about the strength of the evidence.

The results suggest improving sleep hygiene in this population may reduce self-injury, study investigator Sarah E. Bergen, PhD, associate professor, department of medical epidemiology and biostatistics, Karolinska Institute, Stockholm, said in an interview.

In addition, she noted, for “pediatric patients who are experiencing sleep problems, melatonin is a safe and effective way to help them.”

Dr. Bergen believes clinicians should recommend melatonin to all teens because “there’s little harm that could come from it and possibly a lot of benefit.”

The findings were published online in the Journal of Child Psychology and Psychiatry.
 

Few treatments available

Research shows sleep disorders like insomnia are common in youth, particularly among those with psychiatric disorders. Sleep disorders can significantly affect daytime functioning, cognition, emotional regulation, and behavior, and can be a risk factor for unintentional injuries such as falls and vehicular accidents, as well as for intentional self-harm.

The lifetime prevalence of self-harm in youth is estimated to be 17%, but this varies across study designs. There are few treatments for self-harm in youth, although psychosocial treatments appear promising.

Melatonin is a naturally occurring hormone secreted primarily by the pineal gland in response to darkness. It helps promote and maintain the normal sleep-wake cycle and is involved in other biological functions.

In Sweden, melatonin is the most commonly prescribed drug for sleep disturbances in children and adolescents. Prior to 2020, during the course of the study, it was only available by prescription.

The study, which used linked national databases, included 25,575 children and adolescents, 58.2% of them male, who initiated a melatonin treatment between the ages of 6 and 18 years.

Researchers estimated the risks of self-harm, including poisoning (57%) and cutting (34%). The fact that poisoning was more common than cutting was somewhat surprising, said Dr. Bergen. “I would have thought the opposite would be true; that cutting was more prevalent.”

The study examined the risk of self-harm in individual participants by comparing the last unmedicated month with the 12 months after initiating melatonin treatment. In this way, they accounted for potential confounders such as genetics, sleep disorder severity, and psychiatric disorders.

The median age at first melatonin prescription was 13 years for males and 15 years for females.

While there were no statistically significant changes in relative risk for body injuries, falls, and transport accidents, the relative risk for self-injury was statistically significantly lower during the months following melatonin treatment initiation.

The incidence rate ratio in the month following treatment was 0.58 (95% confidence interval, 0.46-0.73) for self-harm and 0.59 (95% CI, 0.45-0.78) for poisoning.
 

Higher risks in females

The relative risk of self-harm was higher in females than males. This, said Dr. Bergen, is possibly because self-harm is more common in adolescence than in childhood. Female study participants were older than their male counterparts.

Melatonin may help male teens, too, she said. “It’s just that the problem is not that great in males to begin with, so a decrease is not very dramatic after melatonin initiation.”

About 87.2% of participants treated with melatonin were diagnosed with at least one psychiatric disorder. Attention-deficit hyperactivity disorder, the most common comorbidity, was diagnosed in more than 50% of new melatonin users. This isn’t surprising, because sleep disturbances are associated with this psychiatric condition and are frequent side effects of ADHD medications.

After ADHD, anxiety and depression were the next most common psychiatric disorders among study subjects. The analysis found risks for self-harm and poisoning were largely driven by patients suffering from one or both of these disorders, particularly among females.

The IRR in the month following melatonin treatment initiation was 0.46 (95% CI, 0.27-0.76] among adolescent females with psychiatric disorders, after excluding antidepressant users.

Melatonin may reduce the risk of self-harm by treating sleep problems related to psychiatric comorbidities, especially anxiety and depression. It could also decrease pain sensitivity experienced by adolescents who self-harm.

Other factors could play a role in treating sleep problems and/or preventing self-harm in these patients. For example, increased clinician awareness and monitoring, behavioral interventions, a placebo effect, and concurrent use of other medications.

When researchers ran an analysis that excluded individuals taking an antidepressant, “surprisingly, there wasn’t much difference,” said Dr. Bergen. “We thought antidepressants might be causing some of the effect we observed, but when we removed antidepressant users, we saw a very similar pattern of intentional self-harm rates following melatonin use, which suggests melatonin is causal, but we can’t prove that.”

Other sleep medications such as sedatives could also affect self-harm rates by improving sleep. However, these are not typically prescribed to children because of their side effects and overdose potential, said Dr. Bergen.

“Melatonin is extremely safe and side effects are rare; it’s impossible to overdose, and people really can’t hurt themselves with it.”
 

More research needed

Adrian Jacques Ambrose, MD, medical director, Columbia University Irving Medical Center, and assistant professor of psychiatry, Columbia University, New York, pointed out some evidence in the study is relatively weak.

“When the authors separated out the on- and off-melatonin groups, it looks like there wasn’t a statistically significant difference [in IRRs] between the two groups – for example, in any injury, self-harm, or poisoning – and this weakens their argument that melatonin is associated with self-harm and poisoning.”

Given the current youth mental health crisis, more research “would absolutely be indicated” to better explore possible additional variables, said Dr. Ambrose.

“For example, some additional follow-up studies may add on covariates in conjunction with melatonin usage, such as the number of medical appointments, the presence of psychotherapeutic interventions, dosage of melatonin, or even the sleepiness scale, to evaluate whether the symptoms of sleep disturbances are more directly correlated with the self-harm behaviors.”

The study was supported by the European Union’s Horizon 2020 Research and Innovation Programme. Dr. Bergen and Dr. Ambrose report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The sleep aid melatonin is associated with a reduced risk of self-harm in adolescents with psychiatric disorders, new research suggests. However, at least one expert has some concerns about the strength of the evidence.

The results suggest improving sleep hygiene in this population may reduce self-injury, study investigator Sarah E. Bergen, PhD, associate professor, department of medical epidemiology and biostatistics, Karolinska Institute, Stockholm, said in an interview.

In addition, she noted, for “pediatric patients who are experiencing sleep problems, melatonin is a safe and effective way to help them.”

Dr. Bergen believes clinicians should recommend melatonin to all teens because “there’s little harm that could come from it and possibly a lot of benefit.”

The findings were published online in the Journal of Child Psychology and Psychiatry.
 

Few treatments available

Research shows sleep disorders like insomnia are common in youth, particularly among those with psychiatric disorders. Sleep disorders can significantly affect daytime functioning, cognition, emotional regulation, and behavior, and can be a risk factor for unintentional injuries such as falls and vehicular accidents, as well as for intentional self-harm.

The lifetime prevalence of self-harm in youth is estimated to be 17%, but this varies across study designs. There are few treatments for self-harm in youth, although psychosocial treatments appear promising.

Melatonin is a naturally occurring hormone secreted primarily by the pineal gland in response to darkness. It helps promote and maintain the normal sleep-wake cycle and is involved in other biological functions.

In Sweden, melatonin is the most commonly prescribed drug for sleep disturbances in children and adolescents. Prior to 2020, during the course of the study, it was only available by prescription.

The study, which used linked national databases, included 25,575 children and adolescents, 58.2% of them male, who initiated a melatonin treatment between the ages of 6 and 18 years.

Researchers estimated the risks of self-harm, including poisoning (57%) and cutting (34%). The fact that poisoning was more common than cutting was somewhat surprising, said Dr. Bergen. “I would have thought the opposite would be true; that cutting was more prevalent.”

The study examined the risk of self-harm in individual participants by comparing the last unmedicated month with the 12 months after initiating melatonin treatment. In this way, they accounted for potential confounders such as genetics, sleep disorder severity, and psychiatric disorders.

The median age at first melatonin prescription was 13 years for males and 15 years for females.

While there were no statistically significant changes in relative risk for body injuries, falls, and transport accidents, the relative risk for self-injury was statistically significantly lower during the months following melatonin treatment initiation.

The incidence rate ratio in the month following treatment was 0.58 (95% confidence interval, 0.46-0.73) for self-harm and 0.59 (95% CI, 0.45-0.78) for poisoning.
 

Higher risks in females

The relative risk of self-harm was higher in females than males. This, said Dr. Bergen, is possibly because self-harm is more common in adolescence than in childhood. Female study participants were older than their male counterparts.

Melatonin may help male teens, too, she said. “It’s just that the problem is not that great in males to begin with, so a decrease is not very dramatic after melatonin initiation.”

About 87.2% of participants treated with melatonin were diagnosed with at least one psychiatric disorder. Attention-deficit hyperactivity disorder, the most common comorbidity, was diagnosed in more than 50% of new melatonin users. This isn’t surprising, because sleep disturbances are associated with this psychiatric condition and are frequent side effects of ADHD medications.

After ADHD, anxiety and depression were the next most common psychiatric disorders among study subjects. The analysis found risks for self-harm and poisoning were largely driven by patients suffering from one or both of these disorders, particularly among females.

The IRR in the month following melatonin treatment initiation was 0.46 (95% CI, 0.27-0.76] among adolescent females with psychiatric disorders, after excluding antidepressant users.

Melatonin may reduce the risk of self-harm by treating sleep problems related to psychiatric comorbidities, especially anxiety and depression. It could also decrease pain sensitivity experienced by adolescents who self-harm.

Other factors could play a role in treating sleep problems and/or preventing self-harm in these patients. For example, increased clinician awareness and monitoring, behavioral interventions, a placebo effect, and concurrent use of other medications.

When researchers ran an analysis that excluded individuals taking an antidepressant, “surprisingly, there wasn’t much difference,” said Dr. Bergen. “We thought antidepressants might be causing some of the effect we observed, but when we removed antidepressant users, we saw a very similar pattern of intentional self-harm rates following melatonin use, which suggests melatonin is causal, but we can’t prove that.”

Other sleep medications such as sedatives could also affect self-harm rates by improving sleep. However, these are not typically prescribed to children because of their side effects and overdose potential, said Dr. Bergen.

“Melatonin is extremely safe and side effects are rare; it’s impossible to overdose, and people really can’t hurt themselves with it.”
 

More research needed

Adrian Jacques Ambrose, MD, medical director, Columbia University Irving Medical Center, and assistant professor of psychiatry, Columbia University, New York, pointed out some evidence in the study is relatively weak.

“When the authors separated out the on- and off-melatonin groups, it looks like there wasn’t a statistically significant difference [in IRRs] between the two groups – for example, in any injury, self-harm, or poisoning – and this weakens their argument that melatonin is associated with self-harm and poisoning.”

Given the current youth mental health crisis, more research “would absolutely be indicated” to better explore possible additional variables, said Dr. Ambrose.

“For example, some additional follow-up studies may add on covariates in conjunction with melatonin usage, such as the number of medical appointments, the presence of psychotherapeutic interventions, dosage of melatonin, or even the sleepiness scale, to evaluate whether the symptoms of sleep disturbances are more directly correlated with the self-harm behaviors.”

The study was supported by the European Union’s Horizon 2020 Research and Innovation Programme. Dr. Bergen and Dr. Ambrose report no relevant financial relationships.

A version of this article first appeared on Medscape.com.