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Single dose of psilocybin for major depression tied to short-term remission
, new research shows.
In the largest study of psilocybin for TRD to date, results of the phase 2b randomized, double-blind trial show participants in the 25-mg dose group experienced a significant reduction in depressive symptoms for at least 3 weeks vs. patients in the 10-mg or 1-mg group, which served as the control group.
Investigators found that 29% of participants who received the 25-mg dose were in remission 3 weeks after the treatment and 37% had at least a 50% drop in depression scores. However, at the 3-month mark, only 20% of those on the 25-mg dose experienced significant improvement.
The change from baseline to week 3 in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score was significantly better with a 25-mg dose than with a 1-mg dose; there was no significant difference between the 10-mg dose and the 1-mg dose, the investigators reported.
The response rate was high for those receiving the 25-mg dose, lead investigator Guy Goodwin, MD, DPhil, told reporters attending a press briefing.
“It’s important to understand that response rates in these patients are usually somewhere between 10% and 20%, and we are seeing remission rates at three weeks of 30%,” he said.
Dr. Goodwin is chief medical officer of COMPASS Pathways, the company that funded the trial and created COMP360, the synthetic formulation of psilocybin used in the trial, and professor emeritus of psychiatry at the University of Oxford, England.
Based on the results of the trial it was announced that a phase 3 trial will launch in December.
The study was published online in the New England Journal of Medicine.
Further research planned
Psilocybin has been under investigation for TRD for some time, including one study that compared it with the antidepressant escitalopram (Lexapro) with promising results.
In the current study the researchers sought to find an acceptable, efficacious dose and the safety of a synthetic formulation of the drug administered in combination with psychological support.
The multicenter study was conducted at 22 sites in 10 countries and included 233 participants with TRD and evaluated the safety and efficacy of one of three doses. The study’s primary endpoint was change from baseline to 3 weeks in MADRS scores in patients with TRD. The scale runs from 0 to 60 with higher scores indicating more severe depression.
Participants were randomly assigned to receive 25 mg of psilocybin (n = 79), 10 mg (n = 75) or 1 mg (n = 79). Those taking medications discontinued them at least 2 weeks before the baseline visit. The mean MADRS score was 32 or 33 in each study group.
There was a 3- to 6-week run-up period to the study in which each participant met with a study therapist about three times to build trust and prepare for the psychedelic experience.
On the day of psilocybin administration, each participant listened to a tailored music playlist and wore eye shades while reclining in a comfortable chair to direct attention inwardly.
The psychotherapy sessions lasted 6-8 hours, and two therapists were always present. The following day, participants returned for an “integration” session with the therapists that was designed to help the participants explore insights from their session.
MADRS scores were measured at baseline, the day following psilocybin administration, and at weeks 1, 3, 6, 9, and 12.
Participants were asked to stay off standard antidepressant treatment during the first 3 weeks of the trial but could be restarted at any time if deemed necessary by a trial investigator.
Mean changes from baseline to week 3 in MADRS scores were −12.0 for 25-mg, −7.9 for 10-mg, and −5.4 for 1-mg groups. The difference between the 25-mg group and 1-mg group was −6.6 (95% confidence interval [CI], −10.2 to −2.9; P < .001 and between the 10-mg group and 1-mg group was −2.5 (95% CI, −6.2 to 1.2; P = .18).
The investigators reported that in the 25-mg group, the incidences of response and remission at 3 weeks, but not sustained response at 12 weeks, were generally supportive of the primary results.
Up to 84% of those who received the 25-mg dosage reported adverse events, with the occurrence dropping slightly with each dosage group. The most frequent adverse events included headache, nausea, dizziness, and fatigue, and occurred only on administration day.
Among those who received the 25-mg dose of psilocybin, two participants reported suicidal thoughts during the 3 weeks following treatment, and 3 months post treatment, three patients exhibited suicidal behavior.
Dr. Goodwin noted that these participants had a prior history of suicidal behavior. Two participants in the 10-mg group also had suicidal thoughts. However, the investigators also noted that suicidal ideation, behavior, or self-injury occurred in all dose groups.
The researchers noted that longer and larger trials, including comparisons with existing depression treatments, are needed to determine the safety and efficacy of psilocybin for TRD.
Intriguing, sobering
In an accompanying editorial, Bertha Madras, PhD, McLean Hospital, Belmont, Mass., and Harvard Medical School, Boston, noted “the findings are both intriguing and sobering. The highest dose (25 mg), but not the intermediate dose (10 mg), resulted in significantly lower levels of depressive symptoms after 3 weeks than the lowest dose (1 mg, which served as a control), but the 37% incidence of response with the 25-mg dose was numerically lower than that in large trials of conventional antidepressants and less robust than in a trial showing similar efficacies of psilocybin and a selective serotonin reuptake inhibitor.”
Also sobering, she noted, were the high percentages of adverse events in the 25-mg group and suicidal ideation and behavior. Dr. Madras also wondered if “legalization and commercialization [of psychedelics] are allied with the medical movement, psychedelic shops and ‘clinics’ could proliferate even for vulnerable populations, and rigorously designed medical protocols will be compromised.
“Nevertheless,” she concluded, “it is provocative that these agents show some short-term benefit for depression in selected populations.”
Dr. Goodwin is CMO of Compass Pathways, which funded the study. He and several coauthors disclosed relationships with industry. Dr. Madras reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows.
In the largest study of psilocybin for TRD to date, results of the phase 2b randomized, double-blind trial show participants in the 25-mg dose group experienced a significant reduction in depressive symptoms for at least 3 weeks vs. patients in the 10-mg or 1-mg group, which served as the control group.
Investigators found that 29% of participants who received the 25-mg dose were in remission 3 weeks after the treatment and 37% had at least a 50% drop in depression scores. However, at the 3-month mark, only 20% of those on the 25-mg dose experienced significant improvement.
The change from baseline to week 3 in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score was significantly better with a 25-mg dose than with a 1-mg dose; there was no significant difference between the 10-mg dose and the 1-mg dose, the investigators reported.
The response rate was high for those receiving the 25-mg dose, lead investigator Guy Goodwin, MD, DPhil, told reporters attending a press briefing.
“It’s important to understand that response rates in these patients are usually somewhere between 10% and 20%, and we are seeing remission rates at three weeks of 30%,” he said.
Dr. Goodwin is chief medical officer of COMPASS Pathways, the company that funded the trial and created COMP360, the synthetic formulation of psilocybin used in the trial, and professor emeritus of psychiatry at the University of Oxford, England.
Based on the results of the trial it was announced that a phase 3 trial will launch in December.
The study was published online in the New England Journal of Medicine.
Further research planned
Psilocybin has been under investigation for TRD for some time, including one study that compared it with the antidepressant escitalopram (Lexapro) with promising results.
In the current study the researchers sought to find an acceptable, efficacious dose and the safety of a synthetic formulation of the drug administered in combination with psychological support.
The multicenter study was conducted at 22 sites in 10 countries and included 233 participants with TRD and evaluated the safety and efficacy of one of three doses. The study’s primary endpoint was change from baseline to 3 weeks in MADRS scores in patients with TRD. The scale runs from 0 to 60 with higher scores indicating more severe depression.
Participants were randomly assigned to receive 25 mg of psilocybin (n = 79), 10 mg (n = 75) or 1 mg (n = 79). Those taking medications discontinued them at least 2 weeks before the baseline visit. The mean MADRS score was 32 or 33 in each study group.
There was a 3- to 6-week run-up period to the study in which each participant met with a study therapist about three times to build trust and prepare for the psychedelic experience.
On the day of psilocybin administration, each participant listened to a tailored music playlist and wore eye shades while reclining in a comfortable chair to direct attention inwardly.
The psychotherapy sessions lasted 6-8 hours, and two therapists were always present. The following day, participants returned for an “integration” session with the therapists that was designed to help the participants explore insights from their session.
MADRS scores were measured at baseline, the day following psilocybin administration, and at weeks 1, 3, 6, 9, and 12.
Participants were asked to stay off standard antidepressant treatment during the first 3 weeks of the trial but could be restarted at any time if deemed necessary by a trial investigator.
Mean changes from baseline to week 3 in MADRS scores were −12.0 for 25-mg, −7.9 for 10-mg, and −5.4 for 1-mg groups. The difference between the 25-mg group and 1-mg group was −6.6 (95% confidence interval [CI], −10.2 to −2.9; P < .001 and between the 10-mg group and 1-mg group was −2.5 (95% CI, −6.2 to 1.2; P = .18).
The investigators reported that in the 25-mg group, the incidences of response and remission at 3 weeks, but not sustained response at 12 weeks, were generally supportive of the primary results.
Up to 84% of those who received the 25-mg dosage reported adverse events, with the occurrence dropping slightly with each dosage group. The most frequent adverse events included headache, nausea, dizziness, and fatigue, and occurred only on administration day.
Among those who received the 25-mg dose of psilocybin, two participants reported suicidal thoughts during the 3 weeks following treatment, and 3 months post treatment, three patients exhibited suicidal behavior.
Dr. Goodwin noted that these participants had a prior history of suicidal behavior. Two participants in the 10-mg group also had suicidal thoughts. However, the investigators also noted that suicidal ideation, behavior, or self-injury occurred in all dose groups.
The researchers noted that longer and larger trials, including comparisons with existing depression treatments, are needed to determine the safety and efficacy of psilocybin for TRD.
Intriguing, sobering
In an accompanying editorial, Bertha Madras, PhD, McLean Hospital, Belmont, Mass., and Harvard Medical School, Boston, noted “the findings are both intriguing and sobering. The highest dose (25 mg), but not the intermediate dose (10 mg), resulted in significantly lower levels of depressive symptoms after 3 weeks than the lowest dose (1 mg, which served as a control), but the 37% incidence of response with the 25-mg dose was numerically lower than that in large trials of conventional antidepressants and less robust than in a trial showing similar efficacies of psilocybin and a selective serotonin reuptake inhibitor.”
Also sobering, she noted, were the high percentages of adverse events in the 25-mg group and suicidal ideation and behavior. Dr. Madras also wondered if “legalization and commercialization [of psychedelics] are allied with the medical movement, psychedelic shops and ‘clinics’ could proliferate even for vulnerable populations, and rigorously designed medical protocols will be compromised.
“Nevertheless,” she concluded, “it is provocative that these agents show some short-term benefit for depression in selected populations.”
Dr. Goodwin is CMO of Compass Pathways, which funded the study. He and several coauthors disclosed relationships with industry. Dr. Madras reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows.
In the largest study of psilocybin for TRD to date, results of the phase 2b randomized, double-blind trial show participants in the 25-mg dose group experienced a significant reduction in depressive symptoms for at least 3 weeks vs. patients in the 10-mg or 1-mg group, which served as the control group.
Investigators found that 29% of participants who received the 25-mg dose were in remission 3 weeks after the treatment and 37% had at least a 50% drop in depression scores. However, at the 3-month mark, only 20% of those on the 25-mg dose experienced significant improvement.
The change from baseline to week 3 in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score was significantly better with a 25-mg dose than with a 1-mg dose; there was no significant difference between the 10-mg dose and the 1-mg dose, the investigators reported.
The response rate was high for those receiving the 25-mg dose, lead investigator Guy Goodwin, MD, DPhil, told reporters attending a press briefing.
“It’s important to understand that response rates in these patients are usually somewhere between 10% and 20%, and we are seeing remission rates at three weeks of 30%,” he said.
Dr. Goodwin is chief medical officer of COMPASS Pathways, the company that funded the trial and created COMP360, the synthetic formulation of psilocybin used in the trial, and professor emeritus of psychiatry at the University of Oxford, England.
Based on the results of the trial it was announced that a phase 3 trial will launch in December.
The study was published online in the New England Journal of Medicine.
Further research planned
Psilocybin has been under investigation for TRD for some time, including one study that compared it with the antidepressant escitalopram (Lexapro) with promising results.
In the current study the researchers sought to find an acceptable, efficacious dose and the safety of a synthetic formulation of the drug administered in combination with psychological support.
The multicenter study was conducted at 22 sites in 10 countries and included 233 participants with TRD and evaluated the safety and efficacy of one of three doses. The study’s primary endpoint was change from baseline to 3 weeks in MADRS scores in patients with TRD. The scale runs from 0 to 60 with higher scores indicating more severe depression.
Participants were randomly assigned to receive 25 mg of psilocybin (n = 79), 10 mg (n = 75) or 1 mg (n = 79). Those taking medications discontinued them at least 2 weeks before the baseline visit. The mean MADRS score was 32 or 33 in each study group.
There was a 3- to 6-week run-up period to the study in which each participant met with a study therapist about three times to build trust and prepare for the psychedelic experience.
On the day of psilocybin administration, each participant listened to a tailored music playlist and wore eye shades while reclining in a comfortable chair to direct attention inwardly.
The psychotherapy sessions lasted 6-8 hours, and two therapists were always present. The following day, participants returned for an “integration” session with the therapists that was designed to help the participants explore insights from their session.
MADRS scores were measured at baseline, the day following psilocybin administration, and at weeks 1, 3, 6, 9, and 12.
Participants were asked to stay off standard antidepressant treatment during the first 3 weeks of the trial but could be restarted at any time if deemed necessary by a trial investigator.
Mean changes from baseline to week 3 in MADRS scores were −12.0 for 25-mg, −7.9 for 10-mg, and −5.4 for 1-mg groups. The difference between the 25-mg group and 1-mg group was −6.6 (95% confidence interval [CI], −10.2 to −2.9; P < .001 and between the 10-mg group and 1-mg group was −2.5 (95% CI, −6.2 to 1.2; P = .18).
The investigators reported that in the 25-mg group, the incidences of response and remission at 3 weeks, but not sustained response at 12 weeks, were generally supportive of the primary results.
Up to 84% of those who received the 25-mg dosage reported adverse events, with the occurrence dropping slightly with each dosage group. The most frequent adverse events included headache, nausea, dizziness, and fatigue, and occurred only on administration day.
Among those who received the 25-mg dose of psilocybin, two participants reported suicidal thoughts during the 3 weeks following treatment, and 3 months post treatment, three patients exhibited suicidal behavior.
Dr. Goodwin noted that these participants had a prior history of suicidal behavior. Two participants in the 10-mg group also had suicidal thoughts. However, the investigators also noted that suicidal ideation, behavior, or self-injury occurred in all dose groups.
The researchers noted that longer and larger trials, including comparisons with existing depression treatments, are needed to determine the safety and efficacy of psilocybin for TRD.
Intriguing, sobering
In an accompanying editorial, Bertha Madras, PhD, McLean Hospital, Belmont, Mass., and Harvard Medical School, Boston, noted “the findings are both intriguing and sobering. The highest dose (25 mg), but not the intermediate dose (10 mg), resulted in significantly lower levels of depressive symptoms after 3 weeks than the lowest dose (1 mg, which served as a control), but the 37% incidence of response with the 25-mg dose was numerically lower than that in large trials of conventional antidepressants and less robust than in a trial showing similar efficacies of psilocybin and a selective serotonin reuptake inhibitor.”
Also sobering, she noted, were the high percentages of adverse events in the 25-mg group and suicidal ideation and behavior. Dr. Madras also wondered if “legalization and commercialization [of psychedelics] are allied with the medical movement, psychedelic shops and ‘clinics’ could proliferate even for vulnerable populations, and rigorously designed medical protocols will be compromised.
“Nevertheless,” she concluded, “it is provocative that these agents show some short-term benefit for depression in selected populations.”
Dr. Goodwin is CMO of Compass Pathways, which funded the study. He and several coauthors disclosed relationships with industry. Dr. Madras reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Major depression treatments boost brain connectivity
VIENNA – , new research suggests.
In a “repeat” MRI study, adult participants with MDD had significantly lower brain connectivity compared with their healthy peers at baseline – but showed significant improvement at the 6-week follow-up. These improvements were associated with decreases in symptom severity, independent of whether they received electroconvulsive therapy (ECT) or other treatment modalities.
“This means that the brain structure of patients with serious clinical depression is not as fixed as we thought, and we can improve brain structure within a short time frame [of] around 6 weeks,” lead author Jonathan Repple, MD, now professor of predictive psychiatry at the University of Frankfurt, Germany, said in a release.
“This gives hope to patients who believe nothing can change and they have to live with a disease forever because it is ‘set in stone’ in their brain,” he added.
The findings were presented at the 35th European College of Neuropsychopharmacology (ECNP) Congress.
‘Easily understandable picture’
Dr. Repple said in an interview that the investigators “were surprised to see how plastic” the brain could be.
“I’ve done a lot of imaging studies in the past where we looked at differences in depression vs. healthy controls, and then maybe had tiny effects. But we’ve never seen such a clear and easily understandable picture, where we see a deficit at the beginning and then a significant increase in whatever biomarker we were looking at, that even correlated with how successful the treatment was,” he said.
Dr. Repple noted that “this is the thing everyone is looking for when we’re talking about a biomarker: That we see this exact pattern” – and it is why they are so excited about the results.
However, he cautioned that the study included a “small sample” and the results need to be independently replicated.
“If this can be replicated, this might be a very good target for future intervention studies,” Dr. Repple said.
The investigators noted that altered brain structural connectivity has been implicated before in the pathophysiology of MDD.
However, it is not clear whether these changes are stable over time and indicate a biological predisposition, or are markers of current disease severity and can be altered by effective treatment.
To investigate further, the researchers used gray matter T1-weighted MRI to define nodes in the brain and diffusion-weighted imaging (DWI)-based tractography to determine connections between the nodes, to create a structural connectome or white matter network.
They performed assessments at baseline and at 6 weeks’ follow-up in 123 participants diagnosed with current MDD and receiving inpatient treatment, and 55 participants who acted as the healthy controls group.
Among the patients with MDD, 56 were treated with ECT and 67 received other antidepressant care, including psychological therapy or medications. Some patients had received all three treatment modalities.
Significant interactions
Results showed a significant interaction by group and time between the baseline and 6-week follow-up assessments (P < .05).
This was partly driven by the MDD group having a significantly lower connectivity strength at baseline than the healthy controls group (P < .05).
It was also partly driven by patients showing a significant improvement in connectivity strength between the baseline and follow-up assessments (P < .05), a pattern that was not seen in the nonpatients.
This increase in connectivity strength was associated with a significant decrease in depression symptom severity (P < .05). This was independent of the treatment modality, indicating that it was not linked to the use of ECT.
Dr. Repple acknowledged the relatively short follow-up period of the study, and added that he is not aware of longitudinal studies of the structural connectome with a longer follow-up.
He pointed out that the structural connectivity of the brain decreases with age, but there have been no studies that have assessed patients with depression and “measured the same person again after 2, 4, 6, or 8 years.”
Dr. Repple reported that the investigators will be following up with their participants, “so hopefully in a few years we’ll have more information on that.
“One thing I also need to stress is that, when we’re looking at the MRI brain scans, we see an increase in connectivity strength, but we really can’t say what the molecular mechanisms behind it are,” he said. “This is a black box for us.”
Several unanswered questions
Commenting in the release, Eric Ruhe, MD, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, said this was a “very interesting and difficult study to perform.”
However, Dr. Ruhe, who was not involved in the research, told this news organization that it is “very difficult to connect the lack of brain connectivity to the patient symptomatology because there is a huge gap between them.”
The problem is that, despite “lots of evidence” that they are effective, “we currently don’t know how antidepressant therapies work” in terms of their underlying mechanisms of action, he said.
“We think that these types of therapies all modulate the plasticity of the brain,” said Dr. Ruhe. “What this study showed is there are changes that you can detect even in 6 weeks,” although they may have been observed even sooner with a shorter follow-up.
He noted that big questions are whether the change is specific to the treatment given, and “can you modulate different brain network dysfunctions with different treatments?”
Moreover, he wondered if a brain scan could indicate which type of treatment should be used. “This is, of course, very new and very challenging, and we don’t know yet, but we should be pursuing this,” Dr. Ruhe said.
Another question is whether or not the brain connectivity changes shown in the study represent a persistent change – “and whether this is a persistent change that is associated with a consistent and persistent relief of depression.
“Again, this is something that needs to be followed up,” said Dr. Ruhe.
No funding was declared. The study authors and Dr. Ruhe report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
VIENNA – , new research suggests.
In a “repeat” MRI study, adult participants with MDD had significantly lower brain connectivity compared with their healthy peers at baseline – but showed significant improvement at the 6-week follow-up. These improvements were associated with decreases in symptom severity, independent of whether they received electroconvulsive therapy (ECT) or other treatment modalities.
“This means that the brain structure of patients with serious clinical depression is not as fixed as we thought, and we can improve brain structure within a short time frame [of] around 6 weeks,” lead author Jonathan Repple, MD, now professor of predictive psychiatry at the University of Frankfurt, Germany, said in a release.
“This gives hope to patients who believe nothing can change and they have to live with a disease forever because it is ‘set in stone’ in their brain,” he added.
The findings were presented at the 35th European College of Neuropsychopharmacology (ECNP) Congress.
‘Easily understandable picture’
Dr. Repple said in an interview that the investigators “were surprised to see how plastic” the brain could be.
“I’ve done a lot of imaging studies in the past where we looked at differences in depression vs. healthy controls, and then maybe had tiny effects. But we’ve never seen such a clear and easily understandable picture, where we see a deficit at the beginning and then a significant increase in whatever biomarker we were looking at, that even correlated with how successful the treatment was,” he said.
Dr. Repple noted that “this is the thing everyone is looking for when we’re talking about a biomarker: That we see this exact pattern” – and it is why they are so excited about the results.
However, he cautioned that the study included a “small sample” and the results need to be independently replicated.
“If this can be replicated, this might be a very good target for future intervention studies,” Dr. Repple said.
The investigators noted that altered brain structural connectivity has been implicated before in the pathophysiology of MDD.
However, it is not clear whether these changes are stable over time and indicate a biological predisposition, or are markers of current disease severity and can be altered by effective treatment.
To investigate further, the researchers used gray matter T1-weighted MRI to define nodes in the brain and diffusion-weighted imaging (DWI)-based tractography to determine connections between the nodes, to create a structural connectome or white matter network.
They performed assessments at baseline and at 6 weeks’ follow-up in 123 participants diagnosed with current MDD and receiving inpatient treatment, and 55 participants who acted as the healthy controls group.
Among the patients with MDD, 56 were treated with ECT and 67 received other antidepressant care, including psychological therapy or medications. Some patients had received all three treatment modalities.
Significant interactions
Results showed a significant interaction by group and time between the baseline and 6-week follow-up assessments (P < .05).
This was partly driven by the MDD group having a significantly lower connectivity strength at baseline than the healthy controls group (P < .05).
It was also partly driven by patients showing a significant improvement in connectivity strength between the baseline and follow-up assessments (P < .05), a pattern that was not seen in the nonpatients.
This increase in connectivity strength was associated with a significant decrease in depression symptom severity (P < .05). This was independent of the treatment modality, indicating that it was not linked to the use of ECT.
Dr. Repple acknowledged the relatively short follow-up period of the study, and added that he is not aware of longitudinal studies of the structural connectome with a longer follow-up.
He pointed out that the structural connectivity of the brain decreases with age, but there have been no studies that have assessed patients with depression and “measured the same person again after 2, 4, 6, or 8 years.”
Dr. Repple reported that the investigators will be following up with their participants, “so hopefully in a few years we’ll have more information on that.
“One thing I also need to stress is that, when we’re looking at the MRI brain scans, we see an increase in connectivity strength, but we really can’t say what the molecular mechanisms behind it are,” he said. “This is a black box for us.”
Several unanswered questions
Commenting in the release, Eric Ruhe, MD, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, said this was a “very interesting and difficult study to perform.”
However, Dr. Ruhe, who was not involved in the research, told this news organization that it is “very difficult to connect the lack of brain connectivity to the patient symptomatology because there is a huge gap between them.”
The problem is that, despite “lots of evidence” that they are effective, “we currently don’t know how antidepressant therapies work” in terms of their underlying mechanisms of action, he said.
“We think that these types of therapies all modulate the plasticity of the brain,” said Dr. Ruhe. “What this study showed is there are changes that you can detect even in 6 weeks,” although they may have been observed even sooner with a shorter follow-up.
He noted that big questions are whether the change is specific to the treatment given, and “can you modulate different brain network dysfunctions with different treatments?”
Moreover, he wondered if a brain scan could indicate which type of treatment should be used. “This is, of course, very new and very challenging, and we don’t know yet, but we should be pursuing this,” Dr. Ruhe said.
Another question is whether or not the brain connectivity changes shown in the study represent a persistent change – “and whether this is a persistent change that is associated with a consistent and persistent relief of depression.
“Again, this is something that needs to be followed up,” said Dr. Ruhe.
No funding was declared. The study authors and Dr. Ruhe report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
VIENNA – , new research suggests.
In a “repeat” MRI study, adult participants with MDD had significantly lower brain connectivity compared with their healthy peers at baseline – but showed significant improvement at the 6-week follow-up. These improvements were associated with decreases in symptom severity, independent of whether they received electroconvulsive therapy (ECT) or other treatment modalities.
“This means that the brain structure of patients with serious clinical depression is not as fixed as we thought, and we can improve brain structure within a short time frame [of] around 6 weeks,” lead author Jonathan Repple, MD, now professor of predictive psychiatry at the University of Frankfurt, Germany, said in a release.
“This gives hope to patients who believe nothing can change and they have to live with a disease forever because it is ‘set in stone’ in their brain,” he added.
The findings were presented at the 35th European College of Neuropsychopharmacology (ECNP) Congress.
‘Easily understandable picture’
Dr. Repple said in an interview that the investigators “were surprised to see how plastic” the brain could be.
“I’ve done a lot of imaging studies in the past where we looked at differences in depression vs. healthy controls, and then maybe had tiny effects. But we’ve never seen such a clear and easily understandable picture, where we see a deficit at the beginning and then a significant increase in whatever biomarker we were looking at, that even correlated with how successful the treatment was,” he said.
Dr. Repple noted that “this is the thing everyone is looking for when we’re talking about a biomarker: That we see this exact pattern” – and it is why they are so excited about the results.
However, he cautioned that the study included a “small sample” and the results need to be independently replicated.
“If this can be replicated, this might be a very good target for future intervention studies,” Dr. Repple said.
The investigators noted that altered brain structural connectivity has been implicated before in the pathophysiology of MDD.
However, it is not clear whether these changes are stable over time and indicate a biological predisposition, or are markers of current disease severity and can be altered by effective treatment.
To investigate further, the researchers used gray matter T1-weighted MRI to define nodes in the brain and diffusion-weighted imaging (DWI)-based tractography to determine connections between the nodes, to create a structural connectome or white matter network.
They performed assessments at baseline and at 6 weeks’ follow-up in 123 participants diagnosed with current MDD and receiving inpatient treatment, and 55 participants who acted as the healthy controls group.
Among the patients with MDD, 56 were treated with ECT and 67 received other antidepressant care, including psychological therapy or medications. Some patients had received all three treatment modalities.
Significant interactions
Results showed a significant interaction by group and time between the baseline and 6-week follow-up assessments (P < .05).
This was partly driven by the MDD group having a significantly lower connectivity strength at baseline than the healthy controls group (P < .05).
It was also partly driven by patients showing a significant improvement in connectivity strength between the baseline and follow-up assessments (P < .05), a pattern that was not seen in the nonpatients.
This increase in connectivity strength was associated with a significant decrease in depression symptom severity (P < .05). This was independent of the treatment modality, indicating that it was not linked to the use of ECT.
Dr. Repple acknowledged the relatively short follow-up period of the study, and added that he is not aware of longitudinal studies of the structural connectome with a longer follow-up.
He pointed out that the structural connectivity of the brain decreases with age, but there have been no studies that have assessed patients with depression and “measured the same person again after 2, 4, 6, or 8 years.”
Dr. Repple reported that the investigators will be following up with their participants, “so hopefully in a few years we’ll have more information on that.
“One thing I also need to stress is that, when we’re looking at the MRI brain scans, we see an increase in connectivity strength, but we really can’t say what the molecular mechanisms behind it are,” he said. “This is a black box for us.”
Several unanswered questions
Commenting in the release, Eric Ruhe, MD, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, said this was a “very interesting and difficult study to perform.”
However, Dr. Ruhe, who was not involved in the research, told this news organization that it is “very difficult to connect the lack of brain connectivity to the patient symptomatology because there is a huge gap between them.”
The problem is that, despite “lots of evidence” that they are effective, “we currently don’t know how antidepressant therapies work” in terms of their underlying mechanisms of action, he said.
“We think that these types of therapies all modulate the plasticity of the brain,” said Dr. Ruhe. “What this study showed is there are changes that you can detect even in 6 weeks,” although they may have been observed even sooner with a shorter follow-up.
He noted that big questions are whether the change is specific to the treatment given, and “can you modulate different brain network dysfunctions with different treatments?”
Moreover, he wondered if a brain scan could indicate which type of treatment should be used. “This is, of course, very new and very challenging, and we don’t know yet, but we should be pursuing this,” Dr. Ruhe said.
Another question is whether or not the brain connectivity changes shown in the study represent a persistent change – “and whether this is a persistent change that is associated with a consistent and persistent relief of depression.
“Again, this is something that needs to be followed up,” said Dr. Ruhe.
No funding was declared. The study authors and Dr. Ruhe report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ECNP 2022
Antibiotic may enhance noninvasive brain stimulation for depression
“The take-home message is that this proof-of-concept study opens up a new avenue of treatment research so that in the future, we may be able to provide our patients with safe and well-tolerated medications and enhance noninvasive brain stimulation treatments for depression,” senior author Alexander McGirr, MD, PhD, assistant professor of psychiatry, University of Calgary (Alta.), told this news organization.
“Once the safety and efficacy of this strategy have been confirmed with larger multisite studies, this could be deployed within existing health care infrastructure,” he said.
The study was published online in JAMA Psychiatry.
Synaptic plasticity
Repetitive transmagnetic stimulation (rTMS) and the more recently developed intermittent theta-burst stimulation (iTBS) are noninvasive brain stimulation modalities that have the largest evidence base in improving MDD. Although efficacious, an “unacceptable proportion of patients do not significantly improve” with these approaches, the authors write.
“We believe that iTBS improves depression through a process called synaptic plasticity, or how neurons adapt to stimulation, but we know that synaptic plasticity is impacted by the illness,” Dr. McGirr explained. This “could be the reason that only some patients benefit.”
One potential strategy to enhance neuroplasticity is to administer an adjunctive N-methyl D-aspartate (NMDA) receptor agonist during stimulation, since the NMDA receptor is a “key regulator of synaptic plasticity,” the authors state. In fact, synaptic plasticity with continuous and intermittent TBS is NMDA-receptor–dependent.
“DCS is an NMDA receptor partial agonist, and so at the low dose we used in our trial (100 mg), it can facilitate NMDA receptor signaling. The hypothesis was that pairing it with iTBS would enhance synaptic plasticity and clinical outcomes,” Dr. McGirr said.
The group’s previous research demonstrated that targeting the NMDA receptor with low-dose DCS “normalizes long-term motor cortex plasticity in individuals with MDD.” It also led to greater persistence of iTBS-induced changes compared to placebo.
However, “a demonstration that these physiological effects have an impact on treatment outcomes is lacking,” the authors note.
To address this gap, the researchers conducted a 4-week double-blind, placebo-controlled trial in which 50 participants (mean [standard deviation] age, 40.8 [13.4] years; 62% women) were randomly assigned on a 1:1 basis to receive either iTBS plus DCS or iTBS plus placebo (n = 25 per group) for the first 2 weeks of the trial, followed by iTBS without an adjunct for the third and fourth weeks.
Participants were required to be experiencing a major depressive episode and to have failed to respond to at least one adequate antidepressant trial or psychotherapy (but not more than four adequate antidepressant trials during the current episode).
Patients with acute suicidality, psychosis, recent substance use disorder, benzodiazepine use, seizures, unstable medical conditions, history of nonresponse to rTMS or electroconvulsive therapy, or comorbid psychiatric conditions, as well as those for whom psychotherapy was initiated within 3 months of enrollment or during the trial, were excluded.
Depression was measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) (changes in score constituted the primary outcome) and the 17-item Hamilton Depression Rating Scale (17-HDRS).
“Secondary outcomes included clinical response, clinical remission, and Clinical Global Impression (CGI) scores,” the authors state.
“Promising” findings
Most participants in the iTBS plus placebo group were White (80%); 12% were Asian, and 8% were classified as “other.” A smaller proportion of participants in the iTBS plus DCS group were White (68%); the next smallest group was Asian (16%), followed by Hispanic (12%), and “other” (4%).
Participants presented with moderate-severe depressive symptoms, as measured by both the HRDS-17 and the MADRS. The placebo and intervention groups had similar scores at baseline. Resting motor threshold did not differ significantly between the groups, either at baseline or between the weeks with and without adjunctive treatment.
Greater improvements in MADRS scores were found in the intervention group than in the placebo groups (mean difference, –6.15 [95% confidence interval, –2.43 to –9.88]; Hedges g, 0.99 [0.34-1.62]).
A larger treatment effect was found after 4 weeks of treatment than after 2 weeks, although the adjuvant was present for the first 2 weeks. “We speculate that, despite ongoing iTBS, this reflects an erosion of the placebo effect, as 15 of 25 participants (60%) in the iTBS plus placebo group plateaued or had a worsening MADRS score, compared with 9 of 25 participants (36%) in the iTBS plus DCS group,” the authors write.
The intervention group showed higher rates of clinical response compared to the placebo group (73.9% vs. 29.3%, respectively), as well as higher rates of clinical remission (39.1% vs. 4.2%, respectively), as reflected in lower CGI-severity ratings and greater CGI-improvement ratings.
There were no serious adverse events during the trial.
The authors note several limitations, including the small sample size and the fact that participants received the adjunctive treatment for only 2 weeks. Longer treatment courses “require dedicated study.” And the short length of the trial (only 4 weeks) meant the difference between “treatment acceleration” and “treatment enhancement” could not be determined.
Nevertheless, the results are “promising” and suggest additional investigation into “intersectional approaches with other dosing regimens and precision medicine targeting approaches,” the authors state.
Synergistic approach
Commenting on the study, Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt, Towson, Md., called the findings “heartening.” He noted that the study “demonstrates a creative approach of combining an FDA-approved antibiotic with NMDA partial agonist activity – D-cycloserine – with a brief course of iTBS with the aim of enhancing the neuronal plasticity iTBS creates.”
Dr. Aaronson, who is also an adjunct professor at the University of Maryland, Baltimore, and was not involved with the study, added, “This is an early demonstration of the ability to further exploit neuronal changes from neurostimulation by synergistic use of a pharmacologic intervention.”
The study was supported in part by a Young Investigator Award from the Brain and Behavior Research Foundation and the Campus Alberta Innovates Program Chair in Neurostimulation. Dr. McGirr has a patent for PCT/CA2022/050839 pending with MCGRx Corp and is a shareholder of MCGRx Corp. The other authors’ disclosures are listed on the original article. Dr. Aaronson is a consultant for Neuronetics.
A version of this article first appeared on Medscape.com.
“The take-home message is that this proof-of-concept study opens up a new avenue of treatment research so that in the future, we may be able to provide our patients with safe and well-tolerated medications and enhance noninvasive brain stimulation treatments for depression,” senior author Alexander McGirr, MD, PhD, assistant professor of psychiatry, University of Calgary (Alta.), told this news organization.
“Once the safety and efficacy of this strategy have been confirmed with larger multisite studies, this could be deployed within existing health care infrastructure,” he said.
The study was published online in JAMA Psychiatry.
Synaptic plasticity
Repetitive transmagnetic stimulation (rTMS) and the more recently developed intermittent theta-burst stimulation (iTBS) are noninvasive brain stimulation modalities that have the largest evidence base in improving MDD. Although efficacious, an “unacceptable proportion of patients do not significantly improve” with these approaches, the authors write.
“We believe that iTBS improves depression through a process called synaptic plasticity, or how neurons adapt to stimulation, but we know that synaptic plasticity is impacted by the illness,” Dr. McGirr explained. This “could be the reason that only some patients benefit.”
One potential strategy to enhance neuroplasticity is to administer an adjunctive N-methyl D-aspartate (NMDA) receptor agonist during stimulation, since the NMDA receptor is a “key regulator of synaptic plasticity,” the authors state. In fact, synaptic plasticity with continuous and intermittent TBS is NMDA-receptor–dependent.
“DCS is an NMDA receptor partial agonist, and so at the low dose we used in our trial (100 mg), it can facilitate NMDA receptor signaling. The hypothesis was that pairing it with iTBS would enhance synaptic plasticity and clinical outcomes,” Dr. McGirr said.
The group’s previous research demonstrated that targeting the NMDA receptor with low-dose DCS “normalizes long-term motor cortex plasticity in individuals with MDD.” It also led to greater persistence of iTBS-induced changes compared to placebo.
However, “a demonstration that these physiological effects have an impact on treatment outcomes is lacking,” the authors note.
To address this gap, the researchers conducted a 4-week double-blind, placebo-controlled trial in which 50 participants (mean [standard deviation] age, 40.8 [13.4] years; 62% women) were randomly assigned on a 1:1 basis to receive either iTBS plus DCS or iTBS plus placebo (n = 25 per group) for the first 2 weeks of the trial, followed by iTBS without an adjunct for the third and fourth weeks.
Participants were required to be experiencing a major depressive episode and to have failed to respond to at least one adequate antidepressant trial or psychotherapy (but not more than four adequate antidepressant trials during the current episode).
Patients with acute suicidality, psychosis, recent substance use disorder, benzodiazepine use, seizures, unstable medical conditions, history of nonresponse to rTMS or electroconvulsive therapy, or comorbid psychiatric conditions, as well as those for whom psychotherapy was initiated within 3 months of enrollment or during the trial, were excluded.
Depression was measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) (changes in score constituted the primary outcome) and the 17-item Hamilton Depression Rating Scale (17-HDRS).
“Secondary outcomes included clinical response, clinical remission, and Clinical Global Impression (CGI) scores,” the authors state.
“Promising” findings
Most participants in the iTBS plus placebo group were White (80%); 12% were Asian, and 8% were classified as “other.” A smaller proportion of participants in the iTBS plus DCS group were White (68%); the next smallest group was Asian (16%), followed by Hispanic (12%), and “other” (4%).
Participants presented with moderate-severe depressive symptoms, as measured by both the HRDS-17 and the MADRS. The placebo and intervention groups had similar scores at baseline. Resting motor threshold did not differ significantly between the groups, either at baseline or between the weeks with and without adjunctive treatment.
Greater improvements in MADRS scores were found in the intervention group than in the placebo groups (mean difference, –6.15 [95% confidence interval, –2.43 to –9.88]; Hedges g, 0.99 [0.34-1.62]).
A larger treatment effect was found after 4 weeks of treatment than after 2 weeks, although the adjuvant was present for the first 2 weeks. “We speculate that, despite ongoing iTBS, this reflects an erosion of the placebo effect, as 15 of 25 participants (60%) in the iTBS plus placebo group plateaued or had a worsening MADRS score, compared with 9 of 25 participants (36%) in the iTBS plus DCS group,” the authors write.
The intervention group showed higher rates of clinical response compared to the placebo group (73.9% vs. 29.3%, respectively), as well as higher rates of clinical remission (39.1% vs. 4.2%, respectively), as reflected in lower CGI-severity ratings and greater CGI-improvement ratings.
There were no serious adverse events during the trial.
The authors note several limitations, including the small sample size and the fact that participants received the adjunctive treatment for only 2 weeks. Longer treatment courses “require dedicated study.” And the short length of the trial (only 4 weeks) meant the difference between “treatment acceleration” and “treatment enhancement” could not be determined.
Nevertheless, the results are “promising” and suggest additional investigation into “intersectional approaches with other dosing regimens and precision medicine targeting approaches,” the authors state.
Synergistic approach
Commenting on the study, Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt, Towson, Md., called the findings “heartening.” He noted that the study “demonstrates a creative approach of combining an FDA-approved antibiotic with NMDA partial agonist activity – D-cycloserine – with a brief course of iTBS with the aim of enhancing the neuronal plasticity iTBS creates.”
Dr. Aaronson, who is also an adjunct professor at the University of Maryland, Baltimore, and was not involved with the study, added, “This is an early demonstration of the ability to further exploit neuronal changes from neurostimulation by synergistic use of a pharmacologic intervention.”
The study was supported in part by a Young Investigator Award from the Brain and Behavior Research Foundation and the Campus Alberta Innovates Program Chair in Neurostimulation. Dr. McGirr has a patent for PCT/CA2022/050839 pending with MCGRx Corp and is a shareholder of MCGRx Corp. The other authors’ disclosures are listed on the original article. Dr. Aaronson is a consultant for Neuronetics.
A version of this article first appeared on Medscape.com.
“The take-home message is that this proof-of-concept study opens up a new avenue of treatment research so that in the future, we may be able to provide our patients with safe and well-tolerated medications and enhance noninvasive brain stimulation treatments for depression,” senior author Alexander McGirr, MD, PhD, assistant professor of psychiatry, University of Calgary (Alta.), told this news organization.
“Once the safety and efficacy of this strategy have been confirmed with larger multisite studies, this could be deployed within existing health care infrastructure,” he said.
The study was published online in JAMA Psychiatry.
Synaptic plasticity
Repetitive transmagnetic stimulation (rTMS) and the more recently developed intermittent theta-burst stimulation (iTBS) are noninvasive brain stimulation modalities that have the largest evidence base in improving MDD. Although efficacious, an “unacceptable proportion of patients do not significantly improve” with these approaches, the authors write.
“We believe that iTBS improves depression through a process called synaptic plasticity, or how neurons adapt to stimulation, but we know that synaptic plasticity is impacted by the illness,” Dr. McGirr explained. This “could be the reason that only some patients benefit.”
One potential strategy to enhance neuroplasticity is to administer an adjunctive N-methyl D-aspartate (NMDA) receptor agonist during stimulation, since the NMDA receptor is a “key regulator of synaptic plasticity,” the authors state. In fact, synaptic plasticity with continuous and intermittent TBS is NMDA-receptor–dependent.
“DCS is an NMDA receptor partial agonist, and so at the low dose we used in our trial (100 mg), it can facilitate NMDA receptor signaling. The hypothesis was that pairing it with iTBS would enhance synaptic plasticity and clinical outcomes,” Dr. McGirr said.
The group’s previous research demonstrated that targeting the NMDA receptor with low-dose DCS “normalizes long-term motor cortex plasticity in individuals with MDD.” It also led to greater persistence of iTBS-induced changes compared to placebo.
However, “a demonstration that these physiological effects have an impact on treatment outcomes is lacking,” the authors note.
To address this gap, the researchers conducted a 4-week double-blind, placebo-controlled trial in which 50 participants (mean [standard deviation] age, 40.8 [13.4] years; 62% women) were randomly assigned on a 1:1 basis to receive either iTBS plus DCS or iTBS plus placebo (n = 25 per group) for the first 2 weeks of the trial, followed by iTBS without an adjunct for the third and fourth weeks.
Participants were required to be experiencing a major depressive episode and to have failed to respond to at least one adequate antidepressant trial or psychotherapy (but not more than four adequate antidepressant trials during the current episode).
Patients with acute suicidality, psychosis, recent substance use disorder, benzodiazepine use, seizures, unstable medical conditions, history of nonresponse to rTMS or electroconvulsive therapy, or comorbid psychiatric conditions, as well as those for whom psychotherapy was initiated within 3 months of enrollment or during the trial, were excluded.
Depression was measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) (changes in score constituted the primary outcome) and the 17-item Hamilton Depression Rating Scale (17-HDRS).
“Secondary outcomes included clinical response, clinical remission, and Clinical Global Impression (CGI) scores,” the authors state.
“Promising” findings
Most participants in the iTBS plus placebo group were White (80%); 12% were Asian, and 8% were classified as “other.” A smaller proportion of participants in the iTBS plus DCS group were White (68%); the next smallest group was Asian (16%), followed by Hispanic (12%), and “other” (4%).
Participants presented with moderate-severe depressive symptoms, as measured by both the HRDS-17 and the MADRS. The placebo and intervention groups had similar scores at baseline. Resting motor threshold did not differ significantly between the groups, either at baseline or between the weeks with and without adjunctive treatment.
Greater improvements in MADRS scores were found in the intervention group than in the placebo groups (mean difference, –6.15 [95% confidence interval, –2.43 to –9.88]; Hedges g, 0.99 [0.34-1.62]).
A larger treatment effect was found after 4 weeks of treatment than after 2 weeks, although the adjuvant was present for the first 2 weeks. “We speculate that, despite ongoing iTBS, this reflects an erosion of the placebo effect, as 15 of 25 participants (60%) in the iTBS plus placebo group plateaued or had a worsening MADRS score, compared with 9 of 25 participants (36%) in the iTBS plus DCS group,” the authors write.
The intervention group showed higher rates of clinical response compared to the placebo group (73.9% vs. 29.3%, respectively), as well as higher rates of clinical remission (39.1% vs. 4.2%, respectively), as reflected in lower CGI-severity ratings and greater CGI-improvement ratings.
There were no serious adverse events during the trial.
The authors note several limitations, including the small sample size and the fact that participants received the adjunctive treatment for only 2 weeks. Longer treatment courses “require dedicated study.” And the short length of the trial (only 4 weeks) meant the difference between “treatment acceleration” and “treatment enhancement” could not be determined.
Nevertheless, the results are “promising” and suggest additional investigation into “intersectional approaches with other dosing regimens and precision medicine targeting approaches,” the authors state.
Synergistic approach
Commenting on the study, Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt, Towson, Md., called the findings “heartening.” He noted that the study “demonstrates a creative approach of combining an FDA-approved antibiotic with NMDA partial agonist activity – D-cycloserine – with a brief course of iTBS with the aim of enhancing the neuronal plasticity iTBS creates.”
Dr. Aaronson, who is also an adjunct professor at the University of Maryland, Baltimore, and was not involved with the study, added, “This is an early demonstration of the ability to further exploit neuronal changes from neurostimulation by synergistic use of a pharmacologic intervention.”
The study was supported in part by a Young Investigator Award from the Brain and Behavior Research Foundation and the Campus Alberta Innovates Program Chair in Neurostimulation. Dr. McGirr has a patent for PCT/CA2022/050839 pending with MCGRx Corp and is a shareholder of MCGRx Corp. The other authors’ disclosures are listed on the original article. Dr. Aaronson is a consultant for Neuronetics.
A version of this article first appeared on Medscape.com.
FROM JAMA PSYCHIATRY
Brussels terror attack victim euthanized in Belgium at age 23
This article was originally published on MediQuality.com, an online service for health care professionals in the Benelux and a member of the Medscape Professional Network.
Performing euthanasia for “mental suffering that cannot be alleviated” is still considered an extraordinary measure in Belgium. Indeed, fewer than 2% of the requests for euthanasia fall within that category, and few such requests are made by young patients.
to be applicable. It’s something that Belgian broadcaster RTBF brought up during a recent episode of #Investigation, which reported on the aftermath of the 2016 Brussels attacks.
On May 7, surrounded by her family, Ms. De Corte was euthanized. She was 23 years old. Six years earlier, on March 22, 2016, Ms. De Corte had been at Brussels Airport when terrorists set off bombs. She was in the departures area with 90 other students from Sint-Rita Campus College, located in the northern town of Kontich. Ms. De Corte was only a few meters away from the blast. Although she was not physically injured, the Flemish teen was traumatized by the attack. This was confirmed by the school psychologist who treated the students. “There were some students who reacted worse than others to these traumatic events. And having had two discussions with Shanti, I can tell you that she was one of these students who were more sensitive to the effects. To me, it’s quite clear. Even before the attacks, she’d experienced serious psychological issues. Therefore, I referred her for psychiatric care.”
Eleven antidepressants daily
A few weeks after that March day, Ms. De Corte was admitted to a psychiatric hospital in Antwerp. It was a place she knew well, having been an inpatient there several times before the attacks. Ms. De Corte was treated with antidepressants. She shared her thoughts about them on numerous occasions. “I get several drugs at breakfast and up to 11 antidepressants a day. I couldn’t do without them. With all the drugs I take, I feel like a ghost who doesn’t feel anything anymore. Perhaps there were solutions other than the drugs.”
It was a brief respite. In 2020, Ms. De Corte attempted suicide. Her spirits were at their lowest. She was heavily medicated, and her medication had been increased over time. She turned down therapeutic help that was offered by a therapist who specializes in treating the victims of the Brussels attacks. The student got in touch with the Life End Information Forum, an association that supports the right to die with dignity. In April 2022, Ms. De Corte submitted a new euthanasia request, stating that she was in a medically futile condition of mental suffering. Two psychiatrists granted their approval.
A small proportion
Last March, Belgium’s Federal Commission for the Control and Evaluation of Euthanasia reported on data from 2021. “There continues to be a very small number of euthanasia requests that cite mental and behavioral disorders (psychiatric conditions, such as personality disorders, and cognitive issues, like Alzheimer’s disease, are included in this group): 1.9% of all cases of euthanasia. Like all euthanasia files, these requests meet the legal conditions (the patient is legally competent, the request is in writing, the condition is medically futile, and the suffering – which is constant, unbearable, and cannot be alleviated – results from a serious and incurable disorder; the request is well-considered and repeated),” the report states.
This article was translated from MediQuality and appeared on Medscape.com.
This article was originally published on MediQuality.com, an online service for health care professionals in the Benelux and a member of the Medscape Professional Network.
Performing euthanasia for “mental suffering that cannot be alleviated” is still considered an extraordinary measure in Belgium. Indeed, fewer than 2% of the requests for euthanasia fall within that category, and few such requests are made by young patients.
to be applicable. It’s something that Belgian broadcaster RTBF brought up during a recent episode of #Investigation, which reported on the aftermath of the 2016 Brussels attacks.
On May 7, surrounded by her family, Ms. De Corte was euthanized. She was 23 years old. Six years earlier, on March 22, 2016, Ms. De Corte had been at Brussels Airport when terrorists set off bombs. She was in the departures area with 90 other students from Sint-Rita Campus College, located in the northern town of Kontich. Ms. De Corte was only a few meters away from the blast. Although she was not physically injured, the Flemish teen was traumatized by the attack. This was confirmed by the school psychologist who treated the students. “There were some students who reacted worse than others to these traumatic events. And having had two discussions with Shanti, I can tell you that she was one of these students who were more sensitive to the effects. To me, it’s quite clear. Even before the attacks, she’d experienced serious psychological issues. Therefore, I referred her for psychiatric care.”
Eleven antidepressants daily
A few weeks after that March day, Ms. De Corte was admitted to a psychiatric hospital in Antwerp. It was a place she knew well, having been an inpatient there several times before the attacks. Ms. De Corte was treated with antidepressants. She shared her thoughts about them on numerous occasions. “I get several drugs at breakfast and up to 11 antidepressants a day. I couldn’t do without them. With all the drugs I take, I feel like a ghost who doesn’t feel anything anymore. Perhaps there were solutions other than the drugs.”
It was a brief respite. In 2020, Ms. De Corte attempted suicide. Her spirits were at their lowest. She was heavily medicated, and her medication had been increased over time. She turned down therapeutic help that was offered by a therapist who specializes in treating the victims of the Brussels attacks. The student got in touch with the Life End Information Forum, an association that supports the right to die with dignity. In April 2022, Ms. De Corte submitted a new euthanasia request, stating that she was in a medically futile condition of mental suffering. Two psychiatrists granted their approval.
A small proportion
Last March, Belgium’s Federal Commission for the Control and Evaluation of Euthanasia reported on data from 2021. “There continues to be a very small number of euthanasia requests that cite mental and behavioral disorders (psychiatric conditions, such as personality disorders, and cognitive issues, like Alzheimer’s disease, are included in this group): 1.9% of all cases of euthanasia. Like all euthanasia files, these requests meet the legal conditions (the patient is legally competent, the request is in writing, the condition is medically futile, and the suffering – which is constant, unbearable, and cannot be alleviated – results from a serious and incurable disorder; the request is well-considered and repeated),” the report states.
This article was translated from MediQuality and appeared on Medscape.com.
This article was originally published on MediQuality.com, an online service for health care professionals in the Benelux and a member of the Medscape Professional Network.
Performing euthanasia for “mental suffering that cannot be alleviated” is still considered an extraordinary measure in Belgium. Indeed, fewer than 2% of the requests for euthanasia fall within that category, and few such requests are made by young patients.
to be applicable. It’s something that Belgian broadcaster RTBF brought up during a recent episode of #Investigation, which reported on the aftermath of the 2016 Brussels attacks.
On May 7, surrounded by her family, Ms. De Corte was euthanized. She was 23 years old. Six years earlier, on March 22, 2016, Ms. De Corte had been at Brussels Airport when terrorists set off bombs. She was in the departures area with 90 other students from Sint-Rita Campus College, located in the northern town of Kontich. Ms. De Corte was only a few meters away from the blast. Although she was not physically injured, the Flemish teen was traumatized by the attack. This was confirmed by the school psychologist who treated the students. “There were some students who reacted worse than others to these traumatic events. And having had two discussions with Shanti, I can tell you that she was one of these students who were more sensitive to the effects. To me, it’s quite clear. Even before the attacks, she’d experienced serious psychological issues. Therefore, I referred her for psychiatric care.”
Eleven antidepressants daily
A few weeks after that March day, Ms. De Corte was admitted to a psychiatric hospital in Antwerp. It was a place she knew well, having been an inpatient there several times before the attacks. Ms. De Corte was treated with antidepressants. She shared her thoughts about them on numerous occasions. “I get several drugs at breakfast and up to 11 antidepressants a day. I couldn’t do without them. With all the drugs I take, I feel like a ghost who doesn’t feel anything anymore. Perhaps there were solutions other than the drugs.”
It was a brief respite. In 2020, Ms. De Corte attempted suicide. Her spirits were at their lowest. She was heavily medicated, and her medication had been increased over time. She turned down therapeutic help that was offered by a therapist who specializes in treating the victims of the Brussels attacks. The student got in touch with the Life End Information Forum, an association that supports the right to die with dignity. In April 2022, Ms. De Corte submitted a new euthanasia request, stating that she was in a medically futile condition of mental suffering. Two psychiatrists granted their approval.
A small proportion
Last March, Belgium’s Federal Commission for the Control and Evaluation of Euthanasia reported on data from 2021. “There continues to be a very small number of euthanasia requests that cite mental and behavioral disorders (psychiatric conditions, such as personality disorders, and cognitive issues, like Alzheimer’s disease, are included in this group): 1.9% of all cases of euthanasia. Like all euthanasia files, these requests meet the legal conditions (the patient is legally competent, the request is in writing, the condition is medically futile, and the suffering – which is constant, unbearable, and cannot be alleviated – results from a serious and incurable disorder; the request is well-considered and repeated),” the report states.
This article was translated from MediQuality and appeared on Medscape.com.
Preexisting mental illness symptoms spiked during pandemic
“Those with preexisting mental health conditions may be particularly vulnerable to these effects because they are more susceptible to experiencing high levels of stress during a crisis and are more likely to experience isolation/despair during confinement compared to the general population,” wrote Danna Ramirez of The Menninger Clinic, Houston, and colleagues.
In a study published in Psychiatry Research , the investigators compared data from 142 adolescents aged 12-17 years and 470 adults aged 18-79 years who were admitted to an inpatient psychiatric hospital in Houston. Of these, 65 adolescents and 235 adults were admitted before the pandemic, and 77 adolescents and 235 adults were admitted during the pandemic.
Clinical outcomes were scores on the Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire (PHQ-9), the Patient Health Questionnaire for Adolescents (PHQ-A), the Difficulties in Emotion Regulation Scale–Short Form (DERS-SF), the World Health Organization Disability Assessment Scale (WHODAS), the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHOASSIST), the Pittsburgh Sleep Quality Index (PSQI), the Disturbing Dream and Nightmare Severity Index (DDNSI), and the Suicide Behaviors Questionnaire–Revised (SBQ-R).
Overall, adults admitted during the pandemic had significantly higher levels of anxiety, depression, emotional dysregulation, and disability (P < .001 for all) as well as nightmares (P = .013) compared to those admitted prior to the pandemic.
Among adolescents, measures of anxiety, depression, and sleep quality were significantly higher at admission during the pandemic compared to prior to the pandemic (P = .005, P = .005, and P = .011, respectively)
Reasons for the increase in symptom severity remain unclear, but include the possibility that individuals with preexisting mental illness simply became more ill; or that individuals with symptoms delayed hospital admission out of fear of exposure to COVID-19, which resulted in more severe symptoms at admission, the researchers wrote in their discussion.
The findings were limited by several factors, including the primarily White population and the reliance on self-reports, the researchers noted. Another limitation was the lack of differentiation between patients who may have had COVID-19 before hospitalization and those who did not, so the researchers could not determine whether the virus itself played a biological role in symptom severity.
However, the results support data from previous studies and identify increased psychiatry symptom severity for patients admitted for inpatient psychiatry care during the pandemic, they said. Although resources are scarce, the findings emphasize that mental health needs, especially for those with preexisting conditions, should not be overlooked, and continuity and expansion of access to mental health care for all should be prioritized, they concluded.
The study was supported by The Menninger Clinic and The Menninger Clinic Foundation. The researchers had no financial conflicts to disclose.
“Those with preexisting mental health conditions may be particularly vulnerable to these effects because they are more susceptible to experiencing high levels of stress during a crisis and are more likely to experience isolation/despair during confinement compared to the general population,” wrote Danna Ramirez of The Menninger Clinic, Houston, and colleagues.
In a study published in Psychiatry Research , the investigators compared data from 142 adolescents aged 12-17 years and 470 adults aged 18-79 years who were admitted to an inpatient psychiatric hospital in Houston. Of these, 65 adolescents and 235 adults were admitted before the pandemic, and 77 adolescents and 235 adults were admitted during the pandemic.
Clinical outcomes were scores on the Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire (PHQ-9), the Patient Health Questionnaire for Adolescents (PHQ-A), the Difficulties in Emotion Regulation Scale–Short Form (DERS-SF), the World Health Organization Disability Assessment Scale (WHODAS), the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHOASSIST), the Pittsburgh Sleep Quality Index (PSQI), the Disturbing Dream and Nightmare Severity Index (DDNSI), and the Suicide Behaviors Questionnaire–Revised (SBQ-R).
Overall, adults admitted during the pandemic had significantly higher levels of anxiety, depression, emotional dysregulation, and disability (P < .001 for all) as well as nightmares (P = .013) compared to those admitted prior to the pandemic.
Among adolescents, measures of anxiety, depression, and sleep quality were significantly higher at admission during the pandemic compared to prior to the pandemic (P = .005, P = .005, and P = .011, respectively)
Reasons for the increase in symptom severity remain unclear, but include the possibility that individuals with preexisting mental illness simply became more ill; or that individuals with symptoms delayed hospital admission out of fear of exposure to COVID-19, which resulted in more severe symptoms at admission, the researchers wrote in their discussion.
The findings were limited by several factors, including the primarily White population and the reliance on self-reports, the researchers noted. Another limitation was the lack of differentiation between patients who may have had COVID-19 before hospitalization and those who did not, so the researchers could not determine whether the virus itself played a biological role in symptom severity.
However, the results support data from previous studies and identify increased psychiatry symptom severity for patients admitted for inpatient psychiatry care during the pandemic, they said. Although resources are scarce, the findings emphasize that mental health needs, especially for those with preexisting conditions, should not be overlooked, and continuity and expansion of access to mental health care for all should be prioritized, they concluded.
The study was supported by The Menninger Clinic and The Menninger Clinic Foundation. The researchers had no financial conflicts to disclose.
“Those with preexisting mental health conditions may be particularly vulnerable to these effects because they are more susceptible to experiencing high levels of stress during a crisis and are more likely to experience isolation/despair during confinement compared to the general population,” wrote Danna Ramirez of The Menninger Clinic, Houston, and colleagues.
In a study published in Psychiatry Research , the investigators compared data from 142 adolescents aged 12-17 years and 470 adults aged 18-79 years who were admitted to an inpatient psychiatric hospital in Houston. Of these, 65 adolescents and 235 adults were admitted before the pandemic, and 77 adolescents and 235 adults were admitted during the pandemic.
Clinical outcomes were scores on the Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire (PHQ-9), the Patient Health Questionnaire for Adolescents (PHQ-A), the Difficulties in Emotion Regulation Scale–Short Form (DERS-SF), the World Health Organization Disability Assessment Scale (WHODAS), the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHOASSIST), the Pittsburgh Sleep Quality Index (PSQI), the Disturbing Dream and Nightmare Severity Index (DDNSI), and the Suicide Behaviors Questionnaire–Revised (SBQ-R).
Overall, adults admitted during the pandemic had significantly higher levels of anxiety, depression, emotional dysregulation, and disability (P < .001 for all) as well as nightmares (P = .013) compared to those admitted prior to the pandemic.
Among adolescents, measures of anxiety, depression, and sleep quality were significantly higher at admission during the pandemic compared to prior to the pandemic (P = .005, P = .005, and P = .011, respectively)
Reasons for the increase in symptom severity remain unclear, but include the possibility that individuals with preexisting mental illness simply became more ill; or that individuals with symptoms delayed hospital admission out of fear of exposure to COVID-19, which resulted in more severe symptoms at admission, the researchers wrote in their discussion.
The findings were limited by several factors, including the primarily White population and the reliance on self-reports, the researchers noted. Another limitation was the lack of differentiation between patients who may have had COVID-19 before hospitalization and those who did not, so the researchers could not determine whether the virus itself played a biological role in symptom severity.
However, the results support data from previous studies and identify increased psychiatry symptom severity for patients admitted for inpatient psychiatry care during the pandemic, they said. Although resources are scarce, the findings emphasize that mental health needs, especially for those with preexisting conditions, should not be overlooked, and continuity and expansion of access to mental health care for all should be prioritized, they concluded.
The study was supported by The Menninger Clinic and The Menninger Clinic Foundation. The researchers had no financial conflicts to disclose.
FROM PSYCHIATRY RESEARCH
Self-worth training boosts ketamine’s effects in severe depression
The double-blind, randomized clinical trial is the first to assess combining ketamine with a low-cost protective learning program, researchers note.
They add that the findings are an important step toward long-lasting depression treatment for millions of patients whose depression does not improve following first-line therapies.
“One of the biggest challenges in psychiatry and psychology is seeing evidence of longer-term benefits and longer-term compliance,” lead investigator Rebecca B. Price, PhD, associate professor of psychiatry and psychology, University of Pittsburgh, told this news organization.
“Anything that can get somebody well quickly and keep them well for some length of time is really exciting – and a whole paradigm shift for how things have been done up to now,” Dr. Price said.
The findings were published online in the American Journal of Psychiatry.
Promoting self-worth
About one-third of patients with depression remain treatment-resistant even after trying different medications at different doses and at different combinations, the investigators note.
Ketamine and esketamine, a nasal spray formulation of the drug, have been shown previously to improve symptoms in patients with TRD. While the benefits are evident within a few hours of treatment, the effects often wane after just a few weeks.
Ketamine and esketamine must be administered in a clinical setting and patients must be monitored for at least 2 hours after treatment. Repeat dosing is costly, both in time and expense, so clinical researchers have been studying ways to extend the drug’s effects without additional treatments.
The new study combined ketamine treatment with a computer-based active automated self-association training (ASAT) program that the researchers developed. It uses positive words and imagery to promote positive self-image and self-worth.
The trial included 154 adults with treatment-resistant unipolar depression whose symptoms persisted after therapy with at least two medications. Participants received an IV infusion of ketamine 0.5 mg/kg plus active ASAT (n = 53), saline plus active ASAT (n = 51), or ketamine plus sham ASAT (n = 50).
The active program used words like “sweet,” “lovable,” and “worthy” that appeared on the screen interspersed with images of people smiling and the patient’s own photo. Participants were also asked to complete certain mouse-tracking tasks during the session.
The sham ASAT was similar but included neutral words and images. ASAT and sham ASAT were delivered twice daily over 4 consecutive days for 20 minutes.
Clear benefit
Results showed that ketamine rapidly and significantly reduced depression scores within 24 hours of treatment (group-by-time interaction: standardized beta, –1.30; 95% confidence interval, –1.89 to –0.70).
Depression scores in the ketamine-plus-ASAT group remained low and stable over a 30-day period, compared with the saline-plus-ASAT group (standardized beta, –0.61; 95% CI, –0.95 to –0.28).
Participants who received ketamine plus sham ASAT saw initial improvement in symptoms immediately following infusion, but depression symptoms returned after a few weeks.
While researchers hoped to see positive effects from ASAT, “I certainly did not expect to see something so clear to jump right out,” Dr. Price said.
The investigators are now examining whether the computer program can be administered effectively remotely and whether its effects are equally beneficial following treatment with esketamine.
Greatest unmet need
Gerard Sanacora, MD, PhD, professor of psychiatry, and director, Yale Depression Research Program, Yale University, New Haven, Conn., said that extending the effects of ketamine or esketamine without additional dosing is “probably the greatest unmet need in relation to treatments with ketamine and esketamine.”
He added that there are large economic, time, and access burdens associated with the treatment of ketamine.
“Anything we can do to reduce the number of treatments needed or increase the sustainability or the duration of effect would be a tremendous benefit,” said Dr. Sanacora, who was not involved with the research.
Adding an easily accessible, nonpharmacological therapeutic approach to ketamine treatment could be valuable, he said – but more research is needed.
“I’m not sure that this specific associated positive thinking is really the critical component. I think we still have some work to do there. But it does demonstrate that we can use ancillary or augmenting nonpharmacological treatments to extend the effect,” Dr. Sanacora said.
The study was funded by the National Institute of Mental Health and Clinical and Translational Science Institute at the University of Pittsburgh. Dr. Price is the named inventor on a University of Pittsburgh–owned provisional patent filing related to the combination intervention described in this report. Dr. Sanacora reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The double-blind, randomized clinical trial is the first to assess combining ketamine with a low-cost protective learning program, researchers note.
They add that the findings are an important step toward long-lasting depression treatment for millions of patients whose depression does not improve following first-line therapies.
“One of the biggest challenges in psychiatry and psychology is seeing evidence of longer-term benefits and longer-term compliance,” lead investigator Rebecca B. Price, PhD, associate professor of psychiatry and psychology, University of Pittsburgh, told this news organization.
“Anything that can get somebody well quickly and keep them well for some length of time is really exciting – and a whole paradigm shift for how things have been done up to now,” Dr. Price said.
The findings were published online in the American Journal of Psychiatry.
Promoting self-worth
About one-third of patients with depression remain treatment-resistant even after trying different medications at different doses and at different combinations, the investigators note.
Ketamine and esketamine, a nasal spray formulation of the drug, have been shown previously to improve symptoms in patients with TRD. While the benefits are evident within a few hours of treatment, the effects often wane after just a few weeks.
Ketamine and esketamine must be administered in a clinical setting and patients must be monitored for at least 2 hours after treatment. Repeat dosing is costly, both in time and expense, so clinical researchers have been studying ways to extend the drug’s effects without additional treatments.
The new study combined ketamine treatment with a computer-based active automated self-association training (ASAT) program that the researchers developed. It uses positive words and imagery to promote positive self-image and self-worth.
The trial included 154 adults with treatment-resistant unipolar depression whose symptoms persisted after therapy with at least two medications. Participants received an IV infusion of ketamine 0.5 mg/kg plus active ASAT (n = 53), saline plus active ASAT (n = 51), or ketamine plus sham ASAT (n = 50).
The active program used words like “sweet,” “lovable,” and “worthy” that appeared on the screen interspersed with images of people smiling and the patient’s own photo. Participants were also asked to complete certain mouse-tracking tasks during the session.
The sham ASAT was similar but included neutral words and images. ASAT and sham ASAT were delivered twice daily over 4 consecutive days for 20 minutes.
Clear benefit
Results showed that ketamine rapidly and significantly reduced depression scores within 24 hours of treatment (group-by-time interaction: standardized beta, –1.30; 95% confidence interval, –1.89 to –0.70).
Depression scores in the ketamine-plus-ASAT group remained low and stable over a 30-day period, compared with the saline-plus-ASAT group (standardized beta, –0.61; 95% CI, –0.95 to –0.28).
Participants who received ketamine plus sham ASAT saw initial improvement in symptoms immediately following infusion, but depression symptoms returned after a few weeks.
While researchers hoped to see positive effects from ASAT, “I certainly did not expect to see something so clear to jump right out,” Dr. Price said.
The investigators are now examining whether the computer program can be administered effectively remotely and whether its effects are equally beneficial following treatment with esketamine.
Greatest unmet need
Gerard Sanacora, MD, PhD, professor of psychiatry, and director, Yale Depression Research Program, Yale University, New Haven, Conn., said that extending the effects of ketamine or esketamine without additional dosing is “probably the greatest unmet need in relation to treatments with ketamine and esketamine.”
He added that there are large economic, time, and access burdens associated with the treatment of ketamine.
“Anything we can do to reduce the number of treatments needed or increase the sustainability or the duration of effect would be a tremendous benefit,” said Dr. Sanacora, who was not involved with the research.
Adding an easily accessible, nonpharmacological therapeutic approach to ketamine treatment could be valuable, he said – but more research is needed.
“I’m not sure that this specific associated positive thinking is really the critical component. I think we still have some work to do there. But it does demonstrate that we can use ancillary or augmenting nonpharmacological treatments to extend the effect,” Dr. Sanacora said.
The study was funded by the National Institute of Mental Health and Clinical and Translational Science Institute at the University of Pittsburgh. Dr. Price is the named inventor on a University of Pittsburgh–owned provisional patent filing related to the combination intervention described in this report. Dr. Sanacora reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The double-blind, randomized clinical trial is the first to assess combining ketamine with a low-cost protective learning program, researchers note.
They add that the findings are an important step toward long-lasting depression treatment for millions of patients whose depression does not improve following first-line therapies.
“One of the biggest challenges in psychiatry and psychology is seeing evidence of longer-term benefits and longer-term compliance,” lead investigator Rebecca B. Price, PhD, associate professor of psychiatry and psychology, University of Pittsburgh, told this news organization.
“Anything that can get somebody well quickly and keep them well for some length of time is really exciting – and a whole paradigm shift for how things have been done up to now,” Dr. Price said.
The findings were published online in the American Journal of Psychiatry.
Promoting self-worth
About one-third of patients with depression remain treatment-resistant even after trying different medications at different doses and at different combinations, the investigators note.
Ketamine and esketamine, a nasal spray formulation of the drug, have been shown previously to improve symptoms in patients with TRD. While the benefits are evident within a few hours of treatment, the effects often wane after just a few weeks.
Ketamine and esketamine must be administered in a clinical setting and patients must be monitored for at least 2 hours after treatment. Repeat dosing is costly, both in time and expense, so clinical researchers have been studying ways to extend the drug’s effects without additional treatments.
The new study combined ketamine treatment with a computer-based active automated self-association training (ASAT) program that the researchers developed. It uses positive words and imagery to promote positive self-image and self-worth.
The trial included 154 adults with treatment-resistant unipolar depression whose symptoms persisted after therapy with at least two medications. Participants received an IV infusion of ketamine 0.5 mg/kg plus active ASAT (n = 53), saline plus active ASAT (n = 51), or ketamine plus sham ASAT (n = 50).
The active program used words like “sweet,” “lovable,” and “worthy” that appeared on the screen interspersed with images of people smiling and the patient’s own photo. Participants were also asked to complete certain mouse-tracking tasks during the session.
The sham ASAT was similar but included neutral words and images. ASAT and sham ASAT were delivered twice daily over 4 consecutive days for 20 minutes.
Clear benefit
Results showed that ketamine rapidly and significantly reduced depression scores within 24 hours of treatment (group-by-time interaction: standardized beta, –1.30; 95% confidence interval, –1.89 to –0.70).
Depression scores in the ketamine-plus-ASAT group remained low and stable over a 30-day period, compared with the saline-plus-ASAT group (standardized beta, –0.61; 95% CI, –0.95 to –0.28).
Participants who received ketamine plus sham ASAT saw initial improvement in symptoms immediately following infusion, but depression symptoms returned after a few weeks.
While researchers hoped to see positive effects from ASAT, “I certainly did not expect to see something so clear to jump right out,” Dr. Price said.
The investigators are now examining whether the computer program can be administered effectively remotely and whether its effects are equally beneficial following treatment with esketamine.
Greatest unmet need
Gerard Sanacora, MD, PhD, professor of psychiatry, and director, Yale Depression Research Program, Yale University, New Haven, Conn., said that extending the effects of ketamine or esketamine without additional dosing is “probably the greatest unmet need in relation to treatments with ketamine and esketamine.”
He added that there are large economic, time, and access burdens associated with the treatment of ketamine.
“Anything we can do to reduce the number of treatments needed or increase the sustainability or the duration of effect would be a tremendous benefit,” said Dr. Sanacora, who was not involved with the research.
Adding an easily accessible, nonpharmacological therapeutic approach to ketamine treatment could be valuable, he said – but more research is needed.
“I’m not sure that this specific associated positive thinking is really the critical component. I think we still have some work to do there. But it does demonstrate that we can use ancillary or augmenting nonpharmacological treatments to extend the effect,” Dr. Sanacora said.
The study was funded by the National Institute of Mental Health and Clinical and Translational Science Institute at the University of Pittsburgh. Dr. Price is the named inventor on a University of Pittsburgh–owned provisional patent filing related to the combination intervention described in this report. Dr. Sanacora reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AMERICAN JOURNAL OF PSYCHIATRY
‘Disturbing’ lack of follow-up care after psychiatric crises
There is a concerning lack of follow-up care for young people who experience a mental health crisis, new research suggests.
The follow-up rate was less than 30% for those who had visited an ED.
The strongest predictor of follow-up was having received both primary and mental health care during the 6 months prior to using the acute service.
“For people discharging folks after a psychiatric crisis, whether it be in a hospital or emergency room setting, connecting them with their outpatient provider to ensure the transfer of care and continuity of care is vitally important to reduce risks for this population,” coinvestigator Brian Skehan, MD, PhD, assistant professor and psychiatrist, University of Massachusetts, Worcester, said during a press briefing.
If these discharged patients do not have a provider, “make sure they get one,” Lisa Dixon, MD, editor-in-chief of Psychiatric Services, added during the same briefing. “That’s the gift of life potentially for these young people.”
The findings were published online in Psychiatric Services.
Alarming trends
The alarming suicide trends among youths were exacerbated by the COVID-19 pandemic, Dr. Skehan noted.
He cited a 2021 study that showed more than 44% of high school students experienced persistent sadness or hopelessness over the previous year, 1 in 5 seriously considered suicide, and almost 1 in 10 actually attempted suicide.
“When we look at the number of young adults and adolescents struggling with behavioral health issues, the data trend is disturbing nationwide,” Dr. Skehan said.
The current study included participants aged 12-27 years who had private insurance. Many youth in this age category are experiencing significant changes, such as moving from high school to college and from pediatric providers to adult providers – and some “get lost in this transition,” said Dr. Skehan.
He noted many inpatient psychiatric units are not geared to young adults. “They may miss out on some aspects of inpatient care because it’s not geared to their developmental stage,” he said.
Assessing U.S. patient data in the IBM MarketScan commercial database (2013-2018), the researchers created two study samples: 95,153 inpatients and 108,576 patients who used the ED. All had an acute event stemming from a mental health condition.
The investigators explored the role of “established” outpatient care, defined as having had at least one visit with a provider of primary or mental health care in the 6 months prior to the acute psychiatric event.
Covariates included age at time of service (aged 12-17 years or 18-27 years), gender, health care plan type, psychiatric diagnosis, whether the acute event was self-harm or suicide related, and medical complexity.
Low follow-up rates
In the inpatient group, the average age was 18.9 years, the most common length of hospital stay was 4-6 days, and 1.5% left against medical advice. The most common primary diagnosis was major depression (53.7%), followed by bipolar disorder (22.3%). The least common disorders were PTSD, comorbid eating disorders, and disruptive disorders.
About one-third of participants had used both primary and mental health care during the 6 months before hospitalization, whereas 22.8% had no established outpatient care. Established care was most common among those with comorbid eating disorders and least common among those with psychotic disorders.
Results showed 42.7% of the hospitalized patients received follow up within 7 days and 67.4% received follow up within 30 days.
The strongest predictor of mental health follow-up care was established outpatient care. Compared with those who had no such care, those who had received both primary care and mental health care before the acute event had the highest odds of receiving follow-up (within 7 days, adjusted odds ratio, 2.81; 95% confidence interval, 2.68-2.94).
Older age and leaving against medical advice were associated with decreased likelihood of follow-up. Female sex, hospitalizations related to self-harm or suicidality, and longer length of stay were associated with increased likelihood of mental health follow-up care.
Compared with those hospitalized for major depression, those hospitalized for schizophrenia, bipolar disorder, PTSD, disruptive disorders, or comorbid substance use disorder were less likely to receive mental health follow-up. For example, only 23.7% of youth with comorbid substance use discharged from the hospital had follow-up within 7 days.
Similar patterns were observed for 30-day follow-up care.
‘Accessible and appealing’ options needed
In the ED-visit group, the average age was 19.5 years (58% female). Most (70.4%) had no chronic health conditions other than a psychiatric disorder. The primary diagnoses were anxiety disorders or phobias (44.1%) and major depression (23%).
One in four visits included a code for self-harm, suicidal ideation, or suicide attempt. And almost one third lacked established outpatient care before the ED visit.
Results showed 28.6% of the ED group received mental health care follow-up within 7 days and 46.4% received it within 30 days.
Again, the strongest predictor of mental health follow-up was prior outpatient care. For example, compared with participants with no established outpatient care, those with both primary care and mental health care were the most likely to receive follow-up within 7 days (aOR, 4.06; 95% CI, 3.72-4.42).
These numbers “are far from the goal of making sure everybody is getting follow-up care within 7 days of an acute psychiatric event,” Dr. Skehan said.
He stressed the need for “accessible and appealing options for youth.” These could include telehealth services, improved communication among health care providers in the ED, and reducing barriers to access follow-up care.
“This probably highlights the need to have more case management and referral services, and maybe make sure patients have a follow-up appointment before they leave the emergency room,” said Dr. Skehan. “This doesn’t necessarily guarantee they’ll get there but hopefully it makes it more likely they will have that access should they need it.”
The study was funded by grants from the National Institute of General Medical Sciences and the National Center for Advancing Translational Sciences, from the National Institutes of Health. The investigators reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
There is a concerning lack of follow-up care for young people who experience a mental health crisis, new research suggests.
The follow-up rate was less than 30% for those who had visited an ED.
The strongest predictor of follow-up was having received both primary and mental health care during the 6 months prior to using the acute service.
“For people discharging folks after a psychiatric crisis, whether it be in a hospital or emergency room setting, connecting them with their outpatient provider to ensure the transfer of care and continuity of care is vitally important to reduce risks for this population,” coinvestigator Brian Skehan, MD, PhD, assistant professor and psychiatrist, University of Massachusetts, Worcester, said during a press briefing.
If these discharged patients do not have a provider, “make sure they get one,” Lisa Dixon, MD, editor-in-chief of Psychiatric Services, added during the same briefing. “That’s the gift of life potentially for these young people.”
The findings were published online in Psychiatric Services.
Alarming trends
The alarming suicide trends among youths were exacerbated by the COVID-19 pandemic, Dr. Skehan noted.
He cited a 2021 study that showed more than 44% of high school students experienced persistent sadness or hopelessness over the previous year, 1 in 5 seriously considered suicide, and almost 1 in 10 actually attempted suicide.
“When we look at the number of young adults and adolescents struggling with behavioral health issues, the data trend is disturbing nationwide,” Dr. Skehan said.
The current study included participants aged 12-27 years who had private insurance. Many youth in this age category are experiencing significant changes, such as moving from high school to college and from pediatric providers to adult providers – and some “get lost in this transition,” said Dr. Skehan.
He noted many inpatient psychiatric units are not geared to young adults. “They may miss out on some aspects of inpatient care because it’s not geared to their developmental stage,” he said.
Assessing U.S. patient data in the IBM MarketScan commercial database (2013-2018), the researchers created two study samples: 95,153 inpatients and 108,576 patients who used the ED. All had an acute event stemming from a mental health condition.
The investigators explored the role of “established” outpatient care, defined as having had at least one visit with a provider of primary or mental health care in the 6 months prior to the acute psychiatric event.
Covariates included age at time of service (aged 12-17 years or 18-27 years), gender, health care plan type, psychiatric diagnosis, whether the acute event was self-harm or suicide related, and medical complexity.
Low follow-up rates
In the inpatient group, the average age was 18.9 years, the most common length of hospital stay was 4-6 days, and 1.5% left against medical advice. The most common primary diagnosis was major depression (53.7%), followed by bipolar disorder (22.3%). The least common disorders were PTSD, comorbid eating disorders, and disruptive disorders.
About one-third of participants had used both primary and mental health care during the 6 months before hospitalization, whereas 22.8% had no established outpatient care. Established care was most common among those with comorbid eating disorders and least common among those with psychotic disorders.
Results showed 42.7% of the hospitalized patients received follow up within 7 days and 67.4% received follow up within 30 days.
The strongest predictor of mental health follow-up care was established outpatient care. Compared with those who had no such care, those who had received both primary care and mental health care before the acute event had the highest odds of receiving follow-up (within 7 days, adjusted odds ratio, 2.81; 95% confidence interval, 2.68-2.94).
Older age and leaving against medical advice were associated with decreased likelihood of follow-up. Female sex, hospitalizations related to self-harm or suicidality, and longer length of stay were associated with increased likelihood of mental health follow-up care.
Compared with those hospitalized for major depression, those hospitalized for schizophrenia, bipolar disorder, PTSD, disruptive disorders, or comorbid substance use disorder were less likely to receive mental health follow-up. For example, only 23.7% of youth with comorbid substance use discharged from the hospital had follow-up within 7 days.
Similar patterns were observed for 30-day follow-up care.
‘Accessible and appealing’ options needed
In the ED-visit group, the average age was 19.5 years (58% female). Most (70.4%) had no chronic health conditions other than a psychiatric disorder. The primary diagnoses were anxiety disorders or phobias (44.1%) and major depression (23%).
One in four visits included a code for self-harm, suicidal ideation, or suicide attempt. And almost one third lacked established outpatient care before the ED visit.
Results showed 28.6% of the ED group received mental health care follow-up within 7 days and 46.4% received it within 30 days.
Again, the strongest predictor of mental health follow-up was prior outpatient care. For example, compared with participants with no established outpatient care, those with both primary care and mental health care were the most likely to receive follow-up within 7 days (aOR, 4.06; 95% CI, 3.72-4.42).
These numbers “are far from the goal of making sure everybody is getting follow-up care within 7 days of an acute psychiatric event,” Dr. Skehan said.
He stressed the need for “accessible and appealing options for youth.” These could include telehealth services, improved communication among health care providers in the ED, and reducing barriers to access follow-up care.
“This probably highlights the need to have more case management and referral services, and maybe make sure patients have a follow-up appointment before they leave the emergency room,” said Dr. Skehan. “This doesn’t necessarily guarantee they’ll get there but hopefully it makes it more likely they will have that access should they need it.”
The study was funded by grants from the National Institute of General Medical Sciences and the National Center for Advancing Translational Sciences, from the National Institutes of Health. The investigators reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
There is a concerning lack of follow-up care for young people who experience a mental health crisis, new research suggests.
The follow-up rate was less than 30% for those who had visited an ED.
The strongest predictor of follow-up was having received both primary and mental health care during the 6 months prior to using the acute service.
“For people discharging folks after a psychiatric crisis, whether it be in a hospital or emergency room setting, connecting them with their outpatient provider to ensure the transfer of care and continuity of care is vitally important to reduce risks for this population,” coinvestigator Brian Skehan, MD, PhD, assistant professor and psychiatrist, University of Massachusetts, Worcester, said during a press briefing.
If these discharged patients do not have a provider, “make sure they get one,” Lisa Dixon, MD, editor-in-chief of Psychiatric Services, added during the same briefing. “That’s the gift of life potentially for these young people.”
The findings were published online in Psychiatric Services.
Alarming trends
The alarming suicide trends among youths were exacerbated by the COVID-19 pandemic, Dr. Skehan noted.
He cited a 2021 study that showed more than 44% of high school students experienced persistent sadness or hopelessness over the previous year, 1 in 5 seriously considered suicide, and almost 1 in 10 actually attempted suicide.
“When we look at the number of young adults and adolescents struggling with behavioral health issues, the data trend is disturbing nationwide,” Dr. Skehan said.
The current study included participants aged 12-27 years who had private insurance. Many youth in this age category are experiencing significant changes, such as moving from high school to college and from pediatric providers to adult providers – and some “get lost in this transition,” said Dr. Skehan.
He noted many inpatient psychiatric units are not geared to young adults. “They may miss out on some aspects of inpatient care because it’s not geared to their developmental stage,” he said.
Assessing U.S. patient data in the IBM MarketScan commercial database (2013-2018), the researchers created two study samples: 95,153 inpatients and 108,576 patients who used the ED. All had an acute event stemming from a mental health condition.
The investigators explored the role of “established” outpatient care, defined as having had at least one visit with a provider of primary or mental health care in the 6 months prior to the acute psychiatric event.
Covariates included age at time of service (aged 12-17 years or 18-27 years), gender, health care plan type, psychiatric diagnosis, whether the acute event was self-harm or suicide related, and medical complexity.
Low follow-up rates
In the inpatient group, the average age was 18.9 years, the most common length of hospital stay was 4-6 days, and 1.5% left against medical advice. The most common primary diagnosis was major depression (53.7%), followed by bipolar disorder (22.3%). The least common disorders were PTSD, comorbid eating disorders, and disruptive disorders.
About one-third of participants had used both primary and mental health care during the 6 months before hospitalization, whereas 22.8% had no established outpatient care. Established care was most common among those with comorbid eating disorders and least common among those with psychotic disorders.
Results showed 42.7% of the hospitalized patients received follow up within 7 days and 67.4% received follow up within 30 days.
The strongest predictor of mental health follow-up care was established outpatient care. Compared with those who had no such care, those who had received both primary care and mental health care before the acute event had the highest odds of receiving follow-up (within 7 days, adjusted odds ratio, 2.81; 95% confidence interval, 2.68-2.94).
Older age and leaving against medical advice were associated with decreased likelihood of follow-up. Female sex, hospitalizations related to self-harm or suicidality, and longer length of stay were associated with increased likelihood of mental health follow-up care.
Compared with those hospitalized for major depression, those hospitalized for schizophrenia, bipolar disorder, PTSD, disruptive disorders, or comorbid substance use disorder were less likely to receive mental health follow-up. For example, only 23.7% of youth with comorbid substance use discharged from the hospital had follow-up within 7 days.
Similar patterns were observed for 30-day follow-up care.
‘Accessible and appealing’ options needed
In the ED-visit group, the average age was 19.5 years (58% female). Most (70.4%) had no chronic health conditions other than a psychiatric disorder. The primary diagnoses were anxiety disorders or phobias (44.1%) and major depression (23%).
One in four visits included a code for self-harm, suicidal ideation, or suicide attempt. And almost one third lacked established outpatient care before the ED visit.
Results showed 28.6% of the ED group received mental health care follow-up within 7 days and 46.4% received it within 30 days.
Again, the strongest predictor of mental health follow-up was prior outpatient care. For example, compared with participants with no established outpatient care, those with both primary care and mental health care were the most likely to receive follow-up within 7 days (aOR, 4.06; 95% CI, 3.72-4.42).
These numbers “are far from the goal of making sure everybody is getting follow-up care within 7 days of an acute psychiatric event,” Dr. Skehan said.
He stressed the need for “accessible and appealing options for youth.” These could include telehealth services, improved communication among health care providers in the ED, and reducing barriers to access follow-up care.
“This probably highlights the need to have more case management and referral services, and maybe make sure patients have a follow-up appointment before they leave the emergency room,” said Dr. Skehan. “This doesn’t necessarily guarantee they’ll get there but hopefully it makes it more likely they will have that access should they need it.”
The study was funded by grants from the National Institute of General Medical Sciences and the National Center for Advancing Translational Sciences, from the National Institutes of Health. The investigators reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM PSYCHIATRIC SERVICES
Home-based transcranial stimulation succeeds for MDD
Major depressive disorder (MDD) remains a leading cause of disability and a significant predictor of suicide worldwide, Rachel D. Woodham, PhD, of the University of East London and colleagues wrote.
Transcranial direct current stimulation (tDCS) has demonstrated effectiveness as a noninvasive therapy for MDD, but requires frequent sessions, and repeat visits to treatment centers are a barrier for many patients, they noted. The tDCS procedure involves delivery of a weak direct electric current via placement of electrodes, usually with the anode over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex, suborbital, or frontotemporal region.
“The current changes neuronal membrane potential and facilitates discharge,” but “in contrast to rTMS and ECT, tDCS does not directly trigger an action potential,” the researchers wrote. The most common side effects reported with tDCS are tingling, itching, burning sensation, skin redness or headache.
The researchers proposed that tDCS could be provided at home under real-time remote supervision.
In an open-label feasibility study published in the Journal of Psychiatric Research, they recruited 26 adults with MDD in current depressive episodes of moderate to severe severity. In addition to maintaining their current treatment regimens of medication, psychotherapy, or cognitive behavioral therapy, participants used tDCS at home in 30-minute sessions, for a total of 21 sessions over 6 weeks. A researcher was present in person or on a real-time video call for each at-home session.
The primary outcome of Hamilton Rating Scale for Depression (HAMD) score improved significantly, from a mean of 19.12 at baseline to 5.33 after 6 weeks. At 3 months, the mean HAMD score was 5.65, and 78.2% of patients met the criteria for clinical remission (HAMD score less than 9). At 6 months, patients maintained this improvement, with a mean HAMD score of 5.43 and 73.9% of the participants in clinical remission. The majority of participants (24 of 26) completed the full 6-week treatment.
Clinical assessments were conducted at baseline, at the end of the 6-week treatment period, at 3 months, and at 6 months, and included not only the HAMD, but also the Hamilton Anxiety Rating Scale (HAMA), Sheehan Disability Scale (SDS), Patient Health Questionnaire–9 (PHQ-9), and Young Mania Rating Scale. All participants showed significant improvements in HAMA, SDS, and PHQ-9 scores from baseline that endured from the end of the treatment period to the 6 months’ follow-up.
The tDCS involved a bilateral frontal montage, F3 anode, F4 cathode, 2mA, and two different devices were used.
All participants reported the acceptability of at-home tDCS as either “very acceptable” or “quite acceptable.”
The results were limited by the open-label feasibility design and lack of a sham control treatment; therefore, the findings of efficacy are preliminary, the researchers emphasized. “Having real-time supervision for each session likely contributed to symptom improvement.”
However, the results support the feasibility of at-home tDCS to improve outcomes both short- and long-term in patients with moderate to severe MDD, the researchers said. Larger, sham-controlled trials are needed to show efficacy, and additional assessment of feasibility should include the use of app-based devices, which may be more feasible for individuals with lower socioeconomic status.
The study received no outside funding. The study was supported by the Rosetrees Trust. The researchers had no financial conflicts to disclose.
Major depressive disorder (MDD) remains a leading cause of disability and a significant predictor of suicide worldwide, Rachel D. Woodham, PhD, of the University of East London and colleagues wrote.
Transcranial direct current stimulation (tDCS) has demonstrated effectiveness as a noninvasive therapy for MDD, but requires frequent sessions, and repeat visits to treatment centers are a barrier for many patients, they noted. The tDCS procedure involves delivery of a weak direct electric current via placement of electrodes, usually with the anode over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex, suborbital, or frontotemporal region.
“The current changes neuronal membrane potential and facilitates discharge,” but “in contrast to rTMS and ECT, tDCS does not directly trigger an action potential,” the researchers wrote. The most common side effects reported with tDCS are tingling, itching, burning sensation, skin redness or headache.
The researchers proposed that tDCS could be provided at home under real-time remote supervision.
In an open-label feasibility study published in the Journal of Psychiatric Research, they recruited 26 adults with MDD in current depressive episodes of moderate to severe severity. In addition to maintaining their current treatment regimens of medication, psychotherapy, or cognitive behavioral therapy, participants used tDCS at home in 30-minute sessions, for a total of 21 sessions over 6 weeks. A researcher was present in person or on a real-time video call for each at-home session.
The primary outcome of Hamilton Rating Scale for Depression (HAMD) score improved significantly, from a mean of 19.12 at baseline to 5.33 after 6 weeks. At 3 months, the mean HAMD score was 5.65, and 78.2% of patients met the criteria for clinical remission (HAMD score less than 9). At 6 months, patients maintained this improvement, with a mean HAMD score of 5.43 and 73.9% of the participants in clinical remission. The majority of participants (24 of 26) completed the full 6-week treatment.
Clinical assessments were conducted at baseline, at the end of the 6-week treatment period, at 3 months, and at 6 months, and included not only the HAMD, but also the Hamilton Anxiety Rating Scale (HAMA), Sheehan Disability Scale (SDS), Patient Health Questionnaire–9 (PHQ-9), and Young Mania Rating Scale. All participants showed significant improvements in HAMA, SDS, and PHQ-9 scores from baseline that endured from the end of the treatment period to the 6 months’ follow-up.
The tDCS involved a bilateral frontal montage, F3 anode, F4 cathode, 2mA, and two different devices were used.
All participants reported the acceptability of at-home tDCS as either “very acceptable” or “quite acceptable.”
The results were limited by the open-label feasibility design and lack of a sham control treatment; therefore, the findings of efficacy are preliminary, the researchers emphasized. “Having real-time supervision for each session likely contributed to symptom improvement.”
However, the results support the feasibility of at-home tDCS to improve outcomes both short- and long-term in patients with moderate to severe MDD, the researchers said. Larger, sham-controlled trials are needed to show efficacy, and additional assessment of feasibility should include the use of app-based devices, which may be more feasible for individuals with lower socioeconomic status.
The study received no outside funding. The study was supported by the Rosetrees Trust. The researchers had no financial conflicts to disclose.
Major depressive disorder (MDD) remains a leading cause of disability and a significant predictor of suicide worldwide, Rachel D. Woodham, PhD, of the University of East London and colleagues wrote.
Transcranial direct current stimulation (tDCS) has demonstrated effectiveness as a noninvasive therapy for MDD, but requires frequent sessions, and repeat visits to treatment centers are a barrier for many patients, they noted. The tDCS procedure involves delivery of a weak direct electric current via placement of electrodes, usually with the anode over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex, suborbital, or frontotemporal region.
“The current changes neuronal membrane potential and facilitates discharge,” but “in contrast to rTMS and ECT, tDCS does not directly trigger an action potential,” the researchers wrote. The most common side effects reported with tDCS are tingling, itching, burning sensation, skin redness or headache.
The researchers proposed that tDCS could be provided at home under real-time remote supervision.
In an open-label feasibility study published in the Journal of Psychiatric Research, they recruited 26 adults with MDD in current depressive episodes of moderate to severe severity. In addition to maintaining their current treatment regimens of medication, psychotherapy, or cognitive behavioral therapy, participants used tDCS at home in 30-minute sessions, for a total of 21 sessions over 6 weeks. A researcher was present in person or on a real-time video call for each at-home session.
The primary outcome of Hamilton Rating Scale for Depression (HAMD) score improved significantly, from a mean of 19.12 at baseline to 5.33 after 6 weeks. At 3 months, the mean HAMD score was 5.65, and 78.2% of patients met the criteria for clinical remission (HAMD score less than 9). At 6 months, patients maintained this improvement, with a mean HAMD score of 5.43 and 73.9% of the participants in clinical remission. The majority of participants (24 of 26) completed the full 6-week treatment.
Clinical assessments were conducted at baseline, at the end of the 6-week treatment period, at 3 months, and at 6 months, and included not only the HAMD, but also the Hamilton Anxiety Rating Scale (HAMA), Sheehan Disability Scale (SDS), Patient Health Questionnaire–9 (PHQ-9), and Young Mania Rating Scale. All participants showed significant improvements in HAMA, SDS, and PHQ-9 scores from baseline that endured from the end of the treatment period to the 6 months’ follow-up.
The tDCS involved a bilateral frontal montage, F3 anode, F4 cathode, 2mA, and two different devices were used.
All participants reported the acceptability of at-home tDCS as either “very acceptable” or “quite acceptable.”
The results were limited by the open-label feasibility design and lack of a sham control treatment; therefore, the findings of efficacy are preliminary, the researchers emphasized. “Having real-time supervision for each session likely contributed to symptom improvement.”
However, the results support the feasibility of at-home tDCS to improve outcomes both short- and long-term in patients with moderate to severe MDD, the researchers said. Larger, sham-controlled trials are needed to show efficacy, and additional assessment of feasibility should include the use of app-based devices, which may be more feasible for individuals with lower socioeconomic status.
The study received no outside funding. The study was supported by the Rosetrees Trust. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF PSYCHIATRIC RESEARCH
E-health program improves perinatal depression
Patients with perinatal depression who used a specialized online tool showed improvement in symptoms, compared with controls who received routine care, based on data from 191 individuals.
Although perinatal depression affects approximately 17% of pregnant women and 13% of postpartum women, the condition is often underrecognized and undertreated, Brian Danaher, PhD, of Influents Innovations, Eugene, Ore., and colleagues wrote. Meta-analyses have shown that e-health interventions based on cognitive-behavioral therapy (CBT) can improve depression in general and perinatal depression in particular.
An e-health program known as the MomMoodBooster has demonstrated effectiveness at reducing postpartum depression, and the researchers evaluated the effectiveness of a perinatal version.
In a study published in the American Journal of Obstetrics & Gynecology, the researchers randomized 95 pregnant women and 96 postpartum women who met screening criteria for depression to routine care for perinatal depression, which included a 24/7 crisis hotline and a referral network or PDP plus a version of the MomMoodBooster with a perinatal depression component (MMB2). Participants were aged 18 and older, with no active suicidal ideation. The average age was 32 years; 84% were non-Hispanic, 67% were White, and 94% were married or in a long-term relationship. During the 12 weeks, each of six sessions became accessible online in sequence.
The primary endpoint was the change in outcomes at 12 weeks after the start of the program, with depressive symptom severity measured using the Patient Health Questionnaire (PHQ-9). Anxiety was assessed as a secondary outcome by using the Depression Anxiety Stress Scale. The minimal clinically important difference (MCID) was used to evaluate clinical significance, and was defined as a reduction in PHQ-9 of at least 5 points from baseline.
After controlling for perinatal status at baseline and assessment time, the MMB2 group had significantly greater decreases in depression severity and stress compared with the routine care group. In addition, based on MCID, significantly more women in the MMB2 group showed improvements in depression, compared with the routine care group (43% vs. 26%; odds ratio, 2.12; P = .015).
A total of 88 of the 89 women in the MMB2 group accessed the sessions, and approximately half (49%) viewed all six sessions.
Of the women who used the MMB2 program, 96% said that it was easy to use, 93% said they would recommend it, and 83% said it was helpful to them.
The study findings were limited by several factors including the lack of long-term follow-up data and inability to determine the durability of the treatment effects, the researchers noted. Another key limitation is the demographics of the study population (slightly older and a greater proportion of White individuals than the national average), which may not be representative of all perinatal women in the United States.
However, the results are consistent with findings from previous studies, including meta-analyses of CBT-based programs, the researchers wrote.
“When used in a largely self-directed approach, MMB2 could fill the gap when in-person treatment options are limited as well as for women whose circumstances (COVID) and/or concerns (stigma, costs) reduce the acceptability of in-person help,” they said. Use of e-health programs such as MMB2 could increase the scope of treatment for perinatal depression.
Expanding e-health options may improve outcomes and reduce disparities
Perinatal and postpartum depression is one of the most common conditions affecting pregnancy, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview. “Depression can have serious consequences for both maternal and neonatal well-being, including preterm birth, low birth weight, and poor bonding, as well as delayed emotional and cognitive development of the newborn.
“While clinicians are encouraged to screen patients during and after pregnancy for signs and symptoms of depression, once identified, the availability of effective treatment is limited. Access to mental health resources is a long-standing disparity in medicine, and therefore research investigating readily available e-health treatment strategies is critically important,” said Dr. Tanner, who was not involved in the study.
In the current study, “I was surprised by the number of patients who saw a clinically significant improvement in depression scores in such a short period of time. An average of only 20 days elapsed between baseline and post-test scores and almost 43% of patients showed improvement. Mental health interventions typically take longer to demonstrate an effect, both medication and talk therapies,” she said.
“The largest barrier to adoption of any e-health modality into clinical practice is often the cost of implementation and maintaining infrastructure,” said Dr. Tanner. “A cost-effectiveness analysis of this intervention would be helpful to better delineate the value of such of program in comparison to more traditional treatments.”
More research is needed on the effectiveness of the intervention for specific populations, such as groups with lower socioeconomic status and patients with chronic mood disorders, Dr. Tanner said. “Additionally, introducing the program in locations with limited access to mental health resources would support more widespread implementation.”
The study was supported by the National Institutes of Mental Health. The researchers had no financial conflicts to disclose. Dr. Tanner had no financial conflicts to disclose.
Patients with perinatal depression who used a specialized online tool showed improvement in symptoms, compared with controls who received routine care, based on data from 191 individuals.
Although perinatal depression affects approximately 17% of pregnant women and 13% of postpartum women, the condition is often underrecognized and undertreated, Brian Danaher, PhD, of Influents Innovations, Eugene, Ore., and colleagues wrote. Meta-analyses have shown that e-health interventions based on cognitive-behavioral therapy (CBT) can improve depression in general and perinatal depression in particular.
An e-health program known as the MomMoodBooster has demonstrated effectiveness at reducing postpartum depression, and the researchers evaluated the effectiveness of a perinatal version.
In a study published in the American Journal of Obstetrics & Gynecology, the researchers randomized 95 pregnant women and 96 postpartum women who met screening criteria for depression to routine care for perinatal depression, which included a 24/7 crisis hotline and a referral network or PDP plus a version of the MomMoodBooster with a perinatal depression component (MMB2). Participants were aged 18 and older, with no active suicidal ideation. The average age was 32 years; 84% were non-Hispanic, 67% were White, and 94% were married or in a long-term relationship. During the 12 weeks, each of six sessions became accessible online in sequence.
The primary endpoint was the change in outcomes at 12 weeks after the start of the program, with depressive symptom severity measured using the Patient Health Questionnaire (PHQ-9). Anxiety was assessed as a secondary outcome by using the Depression Anxiety Stress Scale. The minimal clinically important difference (MCID) was used to evaluate clinical significance, and was defined as a reduction in PHQ-9 of at least 5 points from baseline.
After controlling for perinatal status at baseline and assessment time, the MMB2 group had significantly greater decreases in depression severity and stress compared with the routine care group. In addition, based on MCID, significantly more women in the MMB2 group showed improvements in depression, compared with the routine care group (43% vs. 26%; odds ratio, 2.12; P = .015).
A total of 88 of the 89 women in the MMB2 group accessed the sessions, and approximately half (49%) viewed all six sessions.
Of the women who used the MMB2 program, 96% said that it was easy to use, 93% said they would recommend it, and 83% said it was helpful to them.
The study findings were limited by several factors including the lack of long-term follow-up data and inability to determine the durability of the treatment effects, the researchers noted. Another key limitation is the demographics of the study population (slightly older and a greater proportion of White individuals than the national average), which may not be representative of all perinatal women in the United States.
However, the results are consistent with findings from previous studies, including meta-analyses of CBT-based programs, the researchers wrote.
“When used in a largely self-directed approach, MMB2 could fill the gap when in-person treatment options are limited as well as for women whose circumstances (COVID) and/or concerns (stigma, costs) reduce the acceptability of in-person help,” they said. Use of e-health programs such as MMB2 could increase the scope of treatment for perinatal depression.
Expanding e-health options may improve outcomes and reduce disparities
Perinatal and postpartum depression is one of the most common conditions affecting pregnancy, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview. “Depression can have serious consequences for both maternal and neonatal well-being, including preterm birth, low birth weight, and poor bonding, as well as delayed emotional and cognitive development of the newborn.
“While clinicians are encouraged to screen patients during and after pregnancy for signs and symptoms of depression, once identified, the availability of effective treatment is limited. Access to mental health resources is a long-standing disparity in medicine, and therefore research investigating readily available e-health treatment strategies is critically important,” said Dr. Tanner, who was not involved in the study.
In the current study, “I was surprised by the number of patients who saw a clinically significant improvement in depression scores in such a short period of time. An average of only 20 days elapsed between baseline and post-test scores and almost 43% of patients showed improvement. Mental health interventions typically take longer to demonstrate an effect, both medication and talk therapies,” she said.
“The largest barrier to adoption of any e-health modality into clinical practice is often the cost of implementation and maintaining infrastructure,” said Dr. Tanner. “A cost-effectiveness analysis of this intervention would be helpful to better delineate the value of such of program in comparison to more traditional treatments.”
More research is needed on the effectiveness of the intervention for specific populations, such as groups with lower socioeconomic status and patients with chronic mood disorders, Dr. Tanner said. “Additionally, introducing the program in locations with limited access to mental health resources would support more widespread implementation.”
The study was supported by the National Institutes of Mental Health. The researchers had no financial conflicts to disclose. Dr. Tanner had no financial conflicts to disclose.
Patients with perinatal depression who used a specialized online tool showed improvement in symptoms, compared with controls who received routine care, based on data from 191 individuals.
Although perinatal depression affects approximately 17% of pregnant women and 13% of postpartum women, the condition is often underrecognized and undertreated, Brian Danaher, PhD, of Influents Innovations, Eugene, Ore., and colleagues wrote. Meta-analyses have shown that e-health interventions based on cognitive-behavioral therapy (CBT) can improve depression in general and perinatal depression in particular.
An e-health program known as the MomMoodBooster has demonstrated effectiveness at reducing postpartum depression, and the researchers evaluated the effectiveness of a perinatal version.
In a study published in the American Journal of Obstetrics & Gynecology, the researchers randomized 95 pregnant women and 96 postpartum women who met screening criteria for depression to routine care for perinatal depression, which included a 24/7 crisis hotline and a referral network or PDP plus a version of the MomMoodBooster with a perinatal depression component (MMB2). Participants were aged 18 and older, with no active suicidal ideation. The average age was 32 years; 84% were non-Hispanic, 67% were White, and 94% were married or in a long-term relationship. During the 12 weeks, each of six sessions became accessible online in sequence.
The primary endpoint was the change in outcomes at 12 weeks after the start of the program, with depressive symptom severity measured using the Patient Health Questionnaire (PHQ-9). Anxiety was assessed as a secondary outcome by using the Depression Anxiety Stress Scale. The minimal clinically important difference (MCID) was used to evaluate clinical significance, and was defined as a reduction in PHQ-9 of at least 5 points from baseline.
After controlling for perinatal status at baseline and assessment time, the MMB2 group had significantly greater decreases in depression severity and stress compared with the routine care group. In addition, based on MCID, significantly more women in the MMB2 group showed improvements in depression, compared with the routine care group (43% vs. 26%; odds ratio, 2.12; P = .015).
A total of 88 of the 89 women in the MMB2 group accessed the sessions, and approximately half (49%) viewed all six sessions.
Of the women who used the MMB2 program, 96% said that it was easy to use, 93% said they would recommend it, and 83% said it was helpful to them.
The study findings were limited by several factors including the lack of long-term follow-up data and inability to determine the durability of the treatment effects, the researchers noted. Another key limitation is the demographics of the study population (slightly older and a greater proportion of White individuals than the national average), which may not be representative of all perinatal women in the United States.
However, the results are consistent with findings from previous studies, including meta-analyses of CBT-based programs, the researchers wrote.
“When used in a largely self-directed approach, MMB2 could fill the gap when in-person treatment options are limited as well as for women whose circumstances (COVID) and/or concerns (stigma, costs) reduce the acceptability of in-person help,” they said. Use of e-health programs such as MMB2 could increase the scope of treatment for perinatal depression.
Expanding e-health options may improve outcomes and reduce disparities
Perinatal and postpartum depression is one of the most common conditions affecting pregnancy, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview. “Depression can have serious consequences for both maternal and neonatal well-being, including preterm birth, low birth weight, and poor bonding, as well as delayed emotional and cognitive development of the newborn.
“While clinicians are encouraged to screen patients during and after pregnancy for signs and symptoms of depression, once identified, the availability of effective treatment is limited. Access to mental health resources is a long-standing disparity in medicine, and therefore research investigating readily available e-health treatment strategies is critically important,” said Dr. Tanner, who was not involved in the study.
In the current study, “I was surprised by the number of patients who saw a clinically significant improvement in depression scores in such a short period of time. An average of only 20 days elapsed between baseline and post-test scores and almost 43% of patients showed improvement. Mental health interventions typically take longer to demonstrate an effect, both medication and talk therapies,” she said.
“The largest barrier to adoption of any e-health modality into clinical practice is often the cost of implementation and maintaining infrastructure,” said Dr. Tanner. “A cost-effectiveness analysis of this intervention would be helpful to better delineate the value of such of program in comparison to more traditional treatments.”
More research is needed on the effectiveness of the intervention for specific populations, such as groups with lower socioeconomic status and patients with chronic mood disorders, Dr. Tanner said. “Additionally, introducing the program in locations with limited access to mental health resources would support more widespread implementation.”
The study was supported by the National Institutes of Mental Health. The researchers had no financial conflicts to disclose. Dr. Tanner had no financial conflicts to disclose.
FROM THE AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY
Digital mental health training acceptable to boarding teens
ANAHEIM, CALIF. – A modular digital intervention to teach mental health skills to youth awaiting transfer to psychiatric care appeared feasible to implement and acceptable to teens and their parents, according to a study presented at the American Academy of Pediatrics National Conference.
“This program has the potential to teach evidence-based mental health skills to youth during boarding, providing a head start on recovery prior to psychiatric hospitalization,” study coauthor Samantha House, DO, MPH, section chief of pediatric hospital medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., told attendees.
Mental health boarding has become increasingly common as psychiatric care resources have been stretched by a crisis in pediatric mental health that began even before the COVID pandemic. Since youth often don’t receive evidence-based therapies while boarding, Dr. House and her coauthor, JoAnna K. Leyenaar, MD, PhD, MPH, developed a pilot program called I-CARE, which stands for Improving Care, Accelerating Recovery and Education.
I-CARE is a digital health intervention that combines videos on a tablet with workbook exercises that teach mental health skills. The seven modules include an introduction and one each on schedule-making, safety planning, psychoeducation, behavioral activation, relaxation skills, and mindfulness skills. Licensed nursing assistants who have received a 6-hour training from a clinical psychologist administer the program and provide safety supervision during boarding.
“I-CARE was designed to be largely self-directed, supported by ‘coaches’ who are not mental health professionals,” Dr. Leyenaar, vice chair of research in the department of pediatrics and an associate professor of pediatrics at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. With this model, the program requires minimal additional resources beyond the tablets and workbooks, and is designed for implementation in settings with few or no mental health professionals, she said.
Cora Breuner, MD, MPH, a professor of pediatrics at the University of Washington, Seattle, and an attending physician at Seattle Children’s Hospital, was not involved in the study but was excited to see it.
“I think it’s a really good idea, and I like that it’s being studied,” Dr. Breuner said in an interview. She said the health care and public health system has let down an entire population who data had shown were experiencing mental health problems.
“We knew before the pandemic that behavioral health issues were creeping up slowly with anxiety, depression, suicidal ideation, and, of course, substance use disorders and eating disorders, and not a lot was being done about it,” Dr. Breuner said, and the pandemic exacerbated those issues. ”I don’t know why no one realized that this was going to be the downstream effect of having no socialization for kids for 18 months and limited resources for those who we need desperately to provide care for,” especially BIPOC [Black, Indigenous, and people of color] kids and underresourced kids.
That sentiment is exactly what inspired the creation of the program, according to Dr. Leyenaar.
The I-CARE program was implemented at Dartmouth Hitchcock Medical Center in November 2021 for adolescents aged 12-17 who were boarding because of suicidality or self-harm. The program and study excluded youth with psychosis and other cognitive or behavioral conditions that didn’t fit with the skills taught by the module training.
The researchers qualitatively evaluated the I-CARE program in youth who were offered at least two I-CARE modules and with parents present during boarding.
Twenty-four youth, with a median age of 14, were offered the I-CARE program between November 2021 and April 2022 while boarding for a median 8 days. Most of the patients were female (79%), and a third were transgender or gender diverse. Most were White (83%), and about two-thirds had Medicaid (62.5%). The most common diagnoses among the participants were major depressive disorder (71%) and generalized anxiety disorder (46%). Others included PTSD (29%), restrictive eating disorder (21%), and bipolar disorder (12.5%).
All offered the program completed the first module, and 79% participated in additional modules. The main reason for discontinuation was transfer to another facility, but a few youth either refused to engage with the program or felt they knew the material well enough that they weren’t benefiting from it.
The evaluation involved 16 youth, seven parents, and 17 clinicians. On a Likert scale, the composite score for the program’s appropriateness – suitability, applicability, and meeting needs – was an average 3.7, with a higher rating from clinicians (4.3) and caregivers (3.5) than youth (2.8).
“Some youth felt the intervention was better suited for a younger audience or those with less familiarity with mental health skills, but they acknowledged that the intervention would be helpful and appropriate for others,” Dr. House, who is also an assistant professor of pediatrics at Geisel School of Medicine, said.
Youth rated the acceptability of the program more highly (3.6) and all three groups found it easy to use, with an average feasibility score of 4 across the board. The program’s acceptability received an average score of 4 from parents and clinicians.
”Teens seem to particularly value the psychoeducation module that explains the relationship between thoughts and feelings, as well as the opportunity to develop a personalized safety plan,” Dr. Leyenaar said.
Among the challenges expressed by the participating teens were that the loud sounds and beeping in the hospital made it difficult to practice mindfulness and that they often had to wait for staff to be available to do I-CARE.
“I feel like not many people have been trained yet,” one teen said, “so to have more nurses available to do I-CARE would be helpful.”
Another participant found the coaches helpful. “Sometimes they were my nurse, sometimes they were someone I never met before. … and also, they were all really, really nice,” the teen said.
Another teen regarded the material as “really surface-level mental health stuff” that they thought “could be helpful to other people who are here for the first time.” But others found the content more beneficial.
“The videos were helpful. … I was worried that they weren’t going to be very informative, but they did make sense to me,” one participant said. “They weren’t overcomplicating things. … They weren’t saying anything I didn’t understand, so that was good.”
The researchers next plan to conduct a multisite study to determine the program’s effectiveness in improving health outcomes and reducing suicidal ideation. Dr. House and Dr. Leyenaar are looking at ways to refine the program.
”We may narrow the age range for participants, with an upper age limit of 16, since some older teens said that the modules were best suited for a younger audience,” Dr. Leyenaar said. “We are also discussing how to best support youth who are readmitted to our hospital and have participated in I-CARE previously.”
Dr. Breuner said she would be interested to see, in future studies of the program, whether it reduced the likelihood of inpatient psychiatric stay, the length of psychiatric stay after admission, or the risk of readmission. She also wondered if the program might be offered in languages other than English, whether a version might be specifically designed for BIPOC youth, and whether the researchers had considered offering the intervention to caregivers as well.
The modules are teaching the kids but should they also be teaching the parents? Dr. Breuner wondered. A lot of times, she said, the parents are bringing these kids in because they don’t know what to do and can’t deal with them anymore. Offering modules on the same skills to caregivers would also enable the caregivers to reinforce and reteach the skills to their children, especially if the youth struggled to really take in what the modules were trying to teach.
Dr. Leyenaar said she expects buy-in for a program like this would be high at other institutions, but it’s premature to scale it up until they’ve conducted at least another clinical trial on its effectiveness. The biggest potential barrier to buy-in that Dr. Breuner perceived would be cost.
“It’s always difficult when it costs money” since the hospital needs to train the clinicians who provide the care, Dr. Breuner said, but it’s possible those costs could be offset if the program reduces the risk of readmission or return to the emergency department.
While the overall risk of harms from the intervention are low, Dr. Breuner said it is important to be conscious that the intervention may not necessarily be appropriate for all youth.
“There’s always risk when there’s a trauma background, and you have to be very careful, especially with mindfulness training,” Dr. Breuner said. For those with a history of abuse or other adverse childhood experiences “for someone to get into a very calm, still place can actually be counterproductive.”
Dr. Breuner especially appreciated that the researchers involved the youth and caregivers in the evaluation process. “That the parents expressed positive attitudes is really incredible,” she said.
Dr. House, Dr. Leyenaar, and Dr. Breuner had no disclosures. No external funding was noted for the study.
ANAHEIM, CALIF. – A modular digital intervention to teach mental health skills to youth awaiting transfer to psychiatric care appeared feasible to implement and acceptable to teens and their parents, according to a study presented at the American Academy of Pediatrics National Conference.
“This program has the potential to teach evidence-based mental health skills to youth during boarding, providing a head start on recovery prior to psychiatric hospitalization,” study coauthor Samantha House, DO, MPH, section chief of pediatric hospital medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., told attendees.
Mental health boarding has become increasingly common as psychiatric care resources have been stretched by a crisis in pediatric mental health that began even before the COVID pandemic. Since youth often don’t receive evidence-based therapies while boarding, Dr. House and her coauthor, JoAnna K. Leyenaar, MD, PhD, MPH, developed a pilot program called I-CARE, which stands for Improving Care, Accelerating Recovery and Education.
I-CARE is a digital health intervention that combines videos on a tablet with workbook exercises that teach mental health skills. The seven modules include an introduction and one each on schedule-making, safety planning, psychoeducation, behavioral activation, relaxation skills, and mindfulness skills. Licensed nursing assistants who have received a 6-hour training from a clinical psychologist administer the program and provide safety supervision during boarding.
“I-CARE was designed to be largely self-directed, supported by ‘coaches’ who are not mental health professionals,” Dr. Leyenaar, vice chair of research in the department of pediatrics and an associate professor of pediatrics at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. With this model, the program requires minimal additional resources beyond the tablets and workbooks, and is designed for implementation in settings with few or no mental health professionals, she said.
Cora Breuner, MD, MPH, a professor of pediatrics at the University of Washington, Seattle, and an attending physician at Seattle Children’s Hospital, was not involved in the study but was excited to see it.
“I think it’s a really good idea, and I like that it’s being studied,” Dr. Breuner said in an interview. She said the health care and public health system has let down an entire population who data had shown were experiencing mental health problems.
“We knew before the pandemic that behavioral health issues were creeping up slowly with anxiety, depression, suicidal ideation, and, of course, substance use disorders and eating disorders, and not a lot was being done about it,” Dr. Breuner said, and the pandemic exacerbated those issues. ”I don’t know why no one realized that this was going to be the downstream effect of having no socialization for kids for 18 months and limited resources for those who we need desperately to provide care for,” especially BIPOC [Black, Indigenous, and people of color] kids and underresourced kids.
That sentiment is exactly what inspired the creation of the program, according to Dr. Leyenaar.
The I-CARE program was implemented at Dartmouth Hitchcock Medical Center in November 2021 for adolescents aged 12-17 who were boarding because of suicidality or self-harm. The program and study excluded youth with psychosis and other cognitive or behavioral conditions that didn’t fit with the skills taught by the module training.
The researchers qualitatively evaluated the I-CARE program in youth who were offered at least two I-CARE modules and with parents present during boarding.
Twenty-four youth, with a median age of 14, were offered the I-CARE program between November 2021 and April 2022 while boarding for a median 8 days. Most of the patients were female (79%), and a third were transgender or gender diverse. Most were White (83%), and about two-thirds had Medicaid (62.5%). The most common diagnoses among the participants were major depressive disorder (71%) and generalized anxiety disorder (46%). Others included PTSD (29%), restrictive eating disorder (21%), and bipolar disorder (12.5%).
All offered the program completed the first module, and 79% participated in additional modules. The main reason for discontinuation was transfer to another facility, but a few youth either refused to engage with the program or felt they knew the material well enough that they weren’t benefiting from it.
The evaluation involved 16 youth, seven parents, and 17 clinicians. On a Likert scale, the composite score for the program’s appropriateness – suitability, applicability, and meeting needs – was an average 3.7, with a higher rating from clinicians (4.3) and caregivers (3.5) than youth (2.8).
“Some youth felt the intervention was better suited for a younger audience or those with less familiarity with mental health skills, but they acknowledged that the intervention would be helpful and appropriate for others,” Dr. House, who is also an assistant professor of pediatrics at Geisel School of Medicine, said.
Youth rated the acceptability of the program more highly (3.6) and all three groups found it easy to use, with an average feasibility score of 4 across the board. The program’s acceptability received an average score of 4 from parents and clinicians.
”Teens seem to particularly value the psychoeducation module that explains the relationship between thoughts and feelings, as well as the opportunity to develop a personalized safety plan,” Dr. Leyenaar said.
Among the challenges expressed by the participating teens were that the loud sounds and beeping in the hospital made it difficult to practice mindfulness and that they often had to wait for staff to be available to do I-CARE.
“I feel like not many people have been trained yet,” one teen said, “so to have more nurses available to do I-CARE would be helpful.”
Another participant found the coaches helpful. “Sometimes they were my nurse, sometimes they were someone I never met before. … and also, they were all really, really nice,” the teen said.
Another teen regarded the material as “really surface-level mental health stuff” that they thought “could be helpful to other people who are here for the first time.” But others found the content more beneficial.
“The videos were helpful. … I was worried that they weren’t going to be very informative, but they did make sense to me,” one participant said. “They weren’t overcomplicating things. … They weren’t saying anything I didn’t understand, so that was good.”
The researchers next plan to conduct a multisite study to determine the program’s effectiveness in improving health outcomes and reducing suicidal ideation. Dr. House and Dr. Leyenaar are looking at ways to refine the program.
”We may narrow the age range for participants, with an upper age limit of 16, since some older teens said that the modules were best suited for a younger audience,” Dr. Leyenaar said. “We are also discussing how to best support youth who are readmitted to our hospital and have participated in I-CARE previously.”
Dr. Breuner said she would be interested to see, in future studies of the program, whether it reduced the likelihood of inpatient psychiatric stay, the length of psychiatric stay after admission, or the risk of readmission. She also wondered if the program might be offered in languages other than English, whether a version might be specifically designed for BIPOC youth, and whether the researchers had considered offering the intervention to caregivers as well.
The modules are teaching the kids but should they also be teaching the parents? Dr. Breuner wondered. A lot of times, she said, the parents are bringing these kids in because they don’t know what to do and can’t deal with them anymore. Offering modules on the same skills to caregivers would also enable the caregivers to reinforce and reteach the skills to their children, especially if the youth struggled to really take in what the modules were trying to teach.
Dr. Leyenaar said she expects buy-in for a program like this would be high at other institutions, but it’s premature to scale it up until they’ve conducted at least another clinical trial on its effectiveness. The biggest potential barrier to buy-in that Dr. Breuner perceived would be cost.
“It’s always difficult when it costs money” since the hospital needs to train the clinicians who provide the care, Dr. Breuner said, but it’s possible those costs could be offset if the program reduces the risk of readmission or return to the emergency department.
While the overall risk of harms from the intervention are low, Dr. Breuner said it is important to be conscious that the intervention may not necessarily be appropriate for all youth.
“There’s always risk when there’s a trauma background, and you have to be very careful, especially with mindfulness training,” Dr. Breuner said. For those with a history of abuse or other adverse childhood experiences “for someone to get into a very calm, still place can actually be counterproductive.”
Dr. Breuner especially appreciated that the researchers involved the youth and caregivers in the evaluation process. “That the parents expressed positive attitudes is really incredible,” she said.
Dr. House, Dr. Leyenaar, and Dr. Breuner had no disclosures. No external funding was noted for the study.
ANAHEIM, CALIF. – A modular digital intervention to teach mental health skills to youth awaiting transfer to psychiatric care appeared feasible to implement and acceptable to teens and their parents, according to a study presented at the American Academy of Pediatrics National Conference.
“This program has the potential to teach evidence-based mental health skills to youth during boarding, providing a head start on recovery prior to psychiatric hospitalization,” study coauthor Samantha House, DO, MPH, section chief of pediatric hospital medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., told attendees.
Mental health boarding has become increasingly common as psychiatric care resources have been stretched by a crisis in pediatric mental health that began even before the COVID pandemic. Since youth often don’t receive evidence-based therapies while boarding, Dr. House and her coauthor, JoAnna K. Leyenaar, MD, PhD, MPH, developed a pilot program called I-CARE, which stands for Improving Care, Accelerating Recovery and Education.
I-CARE is a digital health intervention that combines videos on a tablet with workbook exercises that teach mental health skills. The seven modules include an introduction and one each on schedule-making, safety planning, psychoeducation, behavioral activation, relaxation skills, and mindfulness skills. Licensed nursing assistants who have received a 6-hour training from a clinical psychologist administer the program and provide safety supervision during boarding.
“I-CARE was designed to be largely self-directed, supported by ‘coaches’ who are not mental health professionals,” Dr. Leyenaar, vice chair of research in the department of pediatrics and an associate professor of pediatrics at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. With this model, the program requires minimal additional resources beyond the tablets and workbooks, and is designed for implementation in settings with few or no mental health professionals, she said.
Cora Breuner, MD, MPH, a professor of pediatrics at the University of Washington, Seattle, and an attending physician at Seattle Children’s Hospital, was not involved in the study but was excited to see it.
“I think it’s a really good idea, and I like that it’s being studied,” Dr. Breuner said in an interview. She said the health care and public health system has let down an entire population who data had shown were experiencing mental health problems.
“We knew before the pandemic that behavioral health issues were creeping up slowly with anxiety, depression, suicidal ideation, and, of course, substance use disorders and eating disorders, and not a lot was being done about it,” Dr. Breuner said, and the pandemic exacerbated those issues. ”I don’t know why no one realized that this was going to be the downstream effect of having no socialization for kids for 18 months and limited resources for those who we need desperately to provide care for,” especially BIPOC [Black, Indigenous, and people of color] kids and underresourced kids.
That sentiment is exactly what inspired the creation of the program, according to Dr. Leyenaar.
The I-CARE program was implemented at Dartmouth Hitchcock Medical Center in November 2021 for adolescents aged 12-17 who were boarding because of suicidality or self-harm. The program and study excluded youth with psychosis and other cognitive or behavioral conditions that didn’t fit with the skills taught by the module training.
The researchers qualitatively evaluated the I-CARE program in youth who were offered at least two I-CARE modules and with parents present during boarding.
Twenty-four youth, with a median age of 14, were offered the I-CARE program between November 2021 and April 2022 while boarding for a median 8 days. Most of the patients were female (79%), and a third were transgender or gender diverse. Most were White (83%), and about two-thirds had Medicaid (62.5%). The most common diagnoses among the participants were major depressive disorder (71%) and generalized anxiety disorder (46%). Others included PTSD (29%), restrictive eating disorder (21%), and bipolar disorder (12.5%).
All offered the program completed the first module, and 79% participated in additional modules. The main reason for discontinuation was transfer to another facility, but a few youth either refused to engage with the program or felt they knew the material well enough that they weren’t benefiting from it.
The evaluation involved 16 youth, seven parents, and 17 clinicians. On a Likert scale, the composite score for the program’s appropriateness – suitability, applicability, and meeting needs – was an average 3.7, with a higher rating from clinicians (4.3) and caregivers (3.5) than youth (2.8).
“Some youth felt the intervention was better suited for a younger audience or those with less familiarity with mental health skills, but they acknowledged that the intervention would be helpful and appropriate for others,” Dr. House, who is also an assistant professor of pediatrics at Geisel School of Medicine, said.
Youth rated the acceptability of the program more highly (3.6) and all three groups found it easy to use, with an average feasibility score of 4 across the board. The program’s acceptability received an average score of 4 from parents and clinicians.
”Teens seem to particularly value the psychoeducation module that explains the relationship between thoughts and feelings, as well as the opportunity to develop a personalized safety plan,” Dr. Leyenaar said.
Among the challenges expressed by the participating teens were that the loud sounds and beeping in the hospital made it difficult to practice mindfulness and that they often had to wait for staff to be available to do I-CARE.
“I feel like not many people have been trained yet,” one teen said, “so to have more nurses available to do I-CARE would be helpful.”
Another participant found the coaches helpful. “Sometimes they were my nurse, sometimes they were someone I never met before. … and also, they were all really, really nice,” the teen said.
Another teen regarded the material as “really surface-level mental health stuff” that they thought “could be helpful to other people who are here for the first time.” But others found the content more beneficial.
“The videos were helpful. … I was worried that they weren’t going to be very informative, but they did make sense to me,” one participant said. “They weren’t overcomplicating things. … They weren’t saying anything I didn’t understand, so that was good.”
The researchers next plan to conduct a multisite study to determine the program’s effectiveness in improving health outcomes and reducing suicidal ideation. Dr. House and Dr. Leyenaar are looking at ways to refine the program.
”We may narrow the age range for participants, with an upper age limit of 16, since some older teens said that the modules were best suited for a younger audience,” Dr. Leyenaar said. “We are also discussing how to best support youth who are readmitted to our hospital and have participated in I-CARE previously.”
Dr. Breuner said she would be interested to see, in future studies of the program, whether it reduced the likelihood of inpatient psychiatric stay, the length of psychiatric stay after admission, or the risk of readmission. She also wondered if the program might be offered in languages other than English, whether a version might be specifically designed for BIPOC youth, and whether the researchers had considered offering the intervention to caregivers as well.
The modules are teaching the kids but should they also be teaching the parents? Dr. Breuner wondered. A lot of times, she said, the parents are bringing these kids in because they don’t know what to do and can’t deal with them anymore. Offering modules on the same skills to caregivers would also enable the caregivers to reinforce and reteach the skills to their children, especially if the youth struggled to really take in what the modules were trying to teach.
Dr. Leyenaar said she expects buy-in for a program like this would be high at other institutions, but it’s premature to scale it up until they’ve conducted at least another clinical trial on its effectiveness. The biggest potential barrier to buy-in that Dr. Breuner perceived would be cost.
“It’s always difficult when it costs money” since the hospital needs to train the clinicians who provide the care, Dr. Breuner said, but it’s possible those costs could be offset if the program reduces the risk of readmission or return to the emergency department.
While the overall risk of harms from the intervention are low, Dr. Breuner said it is important to be conscious that the intervention may not necessarily be appropriate for all youth.
“There’s always risk when there’s a trauma background, and you have to be very careful, especially with mindfulness training,” Dr. Breuner said. For those with a history of abuse or other adverse childhood experiences “for someone to get into a very calm, still place can actually be counterproductive.”
Dr. Breuner especially appreciated that the researchers involved the youth and caregivers in the evaluation process. “That the parents expressed positive attitudes is really incredible,” she said.
Dr. House, Dr. Leyenaar, and Dr. Breuner had no disclosures. No external funding was noted for the study.
AT AAP 2022