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Novel medication tied to better quality of life in major depression
DENVER –
In a phase 3 trial that included more than 500 adult patients with MDD, those who received zuranolone for 14 days showed greater improvement at day 15 across numerous QoL outcomes, compared with their counterparts in the placebo group.
In addition, combined analysis of four zuranolone clinical trials showed “mental well-being and functioning improved to near general population norm levels” for the active-treatment group, reported the researchers, led by Anita H. Clayton, MD, chair and professor of psychiatry, University of Virginia, Charlottesville.
“Based on these integrated analyses, the benefit of treatment with zuranolone may extend beyond reduction in depressive symptoms to include potential improvement in quality of life and overall health, as perceived by patients,” they add.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
First oral formulation
Zuranolone represents the second entry in the new class of neuroactive steroid drugs, which modulate GABA-A receptor activity – but it would be the first to have an oral formulation. Brexanolone, which was approved by the Food and Drug Administration in 2019 for postpartum depression, is administered through continuous IV infusion over 60 hours.
As previously reported by this news organization, zuranolone improved depressive symptoms as early as day 3, achieving the primary endpoint of significantly greater reduction in scores on the 17-item Hamilton Rating Scale for Depression from baseline to day 15 versus placebo (P = .014).
In the new analysis, patient-reported measures of functional health and well-being were assessed in the WATERFALL trial. It included 266 patients with MDD who were treated with zuranolone 50 mg daily for 2 weeks and 268 patients with MDD who were treated with placebo.
The study used the Short Form–36 (SF-36v2), which covers a wide range of patient-reported measures, including physical function, bodily pain, general health, vitality, social function, and “role-emotional” symptoms.
Results showed that although the treatment and placebo groups had similar baseline SF-36v2 scores, those receiving zuranolone reported significantly greater improvements at day 15 in almost all of the assessment’s domains, including physical function (treatment difference, 0.8), general health (1.0), vitality (3.1), social functioning (1.1), and role-emotional symptoms (1.5; for all comparisons, P < .05). The only exceptions were in role-physical symptoms and bodily pain.
In measures that included physical function, bodily pain, and general health, the patients achieved improvements at day 15 that were consistent with normal levels, with the improvement in vitality considered clinically meaningful versus placebo.
Integrated data
In further analysis of integrated data from four zuranolone clinical trials in the NEST and LANDSCAPE programs for patients with MDD and postpartum depression, results showed similar improvements at day 15 for zuranolone in QoL and overall health across all of the SF-36v2 functioning and well-being domains (P <.05), with the exceptions of physical measure and bodily pain.
By day 42, all of the domains showed significantly greater improvement with zuranolone versus placebo (all, P <.05).
Among the strongest score improvements in the integrated trials were measures in social functioning, which improved from baseline scores of 29.66 to 42.82 on day 15 and to 43.59 on day 42.
Emotional domain scores improved from 24.43 at baseline to 39.13 on day 15 and to 39.82 on day 42. For mental health, the integrated scores for the zuranolone group improved from 27.13 at baseline to 42.40 on day 15 and 42.62 on day 42.
Of note, the baseline scores for mental health represented just 54.3% of those in the normal population; with the increase at day 15, the level was 84.8% of the normal population.
“Across four completed placebo-controlled NEST and LANDSCAPE clinical trials, patient reports of functional health and well-being as assessed by the SF-36v2 indicated substantial impairment at baseline compared to the population norm,” the researchers reported.
The improvements are especially important in light of the fact that in some patients with MDD, functional improvement is a top priority.
“Patients have often prioritized returning to their usual level of functioning over reduction in depressive symptoms, and functional recovery has been associated with better prognosis of depression,” the investigators wrote.
Zuranolone trials have shown that treatment-emergent adverse events (AEs) occur among about 60% of patients, versus about 44% with placebo. The most common AEs are somnolence, dizziness, headache, sedation, and diarrhea, with no increases in suicidal ideation or withdrawal.
The rates of severe AEs are low, and they are observed in about 3% of patients, versus 1.1% with placebo, the researchers noted.
Further, as opposed to serotonergic antidepressants such as SNRIs and SSRIs, zuranolone does not appear to have the undesirable side effects of decreased libido and sexual dysfunction, they added.
Clinically meaningful?
Andrew J. Cutler, MD, clinical associate professor of psychiatry at State University of New York, Syracuse, said the data are “very significant” for a number of reasons.
“We need more options to treat depression, especially ones with novel mechanisms of action and faster onset of efficacy, such as zuranolone,” said Dr. Cutler, who was not involved in the current study. He has coauthored other studies on zuranolone.
Regarding the study’s QoL outcomes, “while improvement in depressive symptoms is very important, what really matters to patients is improvement in function and quality of life,” Dr. Cutler noted.
Also commenting on the study, Jonathan E. Alpert, MD, PhD, chair of the department of psychiatry and behavioral sciences and professor of psychiatry, neuroscience, and pediatrics at Albert Einstein College of Medicine, New York, said the investigational drug could represent an important addition to the armamentarium for treating depression.
“Zuranolone has good oral bioavailability and would represent the first neuroactive steroid antidepressant available in oral form and, indeed, the first non–monoamine-based antidepressant available in oral form,” he said in an interview.
Dr. Alpert was not involved in the research and has no relationship with the drug’s development.
He noted that although there are modest differences between the patients who received zuranolone and those who received placebo in the trials, “this may have been related to high placebo response rates, which often complicate antidepressant trials.
“Further research is needed to determine whether differences between zuranolone and placebo are clinically meaningful, though the separation between drug and placebo on the primary endpoint, as well as some other measures, such as quality of life measures, is promising,” Dr. Alpert said.
However, he added that comparisons with other active antidepressants in terms of efficacy and tolerability remain to be seen.
“Given the large number of individuals with major depressive disorder who have incomplete response to or do not tolerate monoaminergic antidepressants, the development of agents that leverage novel nonmonoaminergic mechanisms is important,” Dr. Alpert concluded.
The study was funded by Sage Therapeutics and Biogen. Dr. Cutler has been involved in research of zuranolone for Sage Therapeutics. Dr. Alpert has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DENVER –
In a phase 3 trial that included more than 500 adult patients with MDD, those who received zuranolone for 14 days showed greater improvement at day 15 across numerous QoL outcomes, compared with their counterparts in the placebo group.
In addition, combined analysis of four zuranolone clinical trials showed “mental well-being and functioning improved to near general population norm levels” for the active-treatment group, reported the researchers, led by Anita H. Clayton, MD, chair and professor of psychiatry, University of Virginia, Charlottesville.
“Based on these integrated analyses, the benefit of treatment with zuranolone may extend beyond reduction in depressive symptoms to include potential improvement in quality of life and overall health, as perceived by patients,” they add.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
First oral formulation
Zuranolone represents the second entry in the new class of neuroactive steroid drugs, which modulate GABA-A receptor activity – but it would be the first to have an oral formulation. Brexanolone, which was approved by the Food and Drug Administration in 2019 for postpartum depression, is administered through continuous IV infusion over 60 hours.
As previously reported by this news organization, zuranolone improved depressive symptoms as early as day 3, achieving the primary endpoint of significantly greater reduction in scores on the 17-item Hamilton Rating Scale for Depression from baseline to day 15 versus placebo (P = .014).
In the new analysis, patient-reported measures of functional health and well-being were assessed in the WATERFALL trial. It included 266 patients with MDD who were treated with zuranolone 50 mg daily for 2 weeks and 268 patients with MDD who were treated with placebo.
The study used the Short Form–36 (SF-36v2), which covers a wide range of patient-reported measures, including physical function, bodily pain, general health, vitality, social function, and “role-emotional” symptoms.
Results showed that although the treatment and placebo groups had similar baseline SF-36v2 scores, those receiving zuranolone reported significantly greater improvements at day 15 in almost all of the assessment’s domains, including physical function (treatment difference, 0.8), general health (1.0), vitality (3.1), social functioning (1.1), and role-emotional symptoms (1.5; for all comparisons, P < .05). The only exceptions were in role-physical symptoms and bodily pain.
In measures that included physical function, bodily pain, and general health, the patients achieved improvements at day 15 that were consistent with normal levels, with the improvement in vitality considered clinically meaningful versus placebo.
Integrated data
In further analysis of integrated data from four zuranolone clinical trials in the NEST and LANDSCAPE programs for patients with MDD and postpartum depression, results showed similar improvements at day 15 for zuranolone in QoL and overall health across all of the SF-36v2 functioning and well-being domains (P <.05), with the exceptions of physical measure and bodily pain.
By day 42, all of the domains showed significantly greater improvement with zuranolone versus placebo (all, P <.05).
Among the strongest score improvements in the integrated trials were measures in social functioning, which improved from baseline scores of 29.66 to 42.82 on day 15 and to 43.59 on day 42.
Emotional domain scores improved from 24.43 at baseline to 39.13 on day 15 and to 39.82 on day 42. For mental health, the integrated scores for the zuranolone group improved from 27.13 at baseline to 42.40 on day 15 and 42.62 on day 42.
Of note, the baseline scores for mental health represented just 54.3% of those in the normal population; with the increase at day 15, the level was 84.8% of the normal population.
“Across four completed placebo-controlled NEST and LANDSCAPE clinical trials, patient reports of functional health and well-being as assessed by the SF-36v2 indicated substantial impairment at baseline compared to the population norm,” the researchers reported.
The improvements are especially important in light of the fact that in some patients with MDD, functional improvement is a top priority.
“Patients have often prioritized returning to their usual level of functioning over reduction in depressive symptoms, and functional recovery has been associated with better prognosis of depression,” the investigators wrote.
Zuranolone trials have shown that treatment-emergent adverse events (AEs) occur among about 60% of patients, versus about 44% with placebo. The most common AEs are somnolence, dizziness, headache, sedation, and diarrhea, with no increases in suicidal ideation or withdrawal.
The rates of severe AEs are low, and they are observed in about 3% of patients, versus 1.1% with placebo, the researchers noted.
Further, as opposed to serotonergic antidepressants such as SNRIs and SSRIs, zuranolone does not appear to have the undesirable side effects of decreased libido and sexual dysfunction, they added.
Clinically meaningful?
Andrew J. Cutler, MD, clinical associate professor of psychiatry at State University of New York, Syracuse, said the data are “very significant” for a number of reasons.
“We need more options to treat depression, especially ones with novel mechanisms of action and faster onset of efficacy, such as zuranolone,” said Dr. Cutler, who was not involved in the current study. He has coauthored other studies on zuranolone.
Regarding the study’s QoL outcomes, “while improvement in depressive symptoms is very important, what really matters to patients is improvement in function and quality of life,” Dr. Cutler noted.
Also commenting on the study, Jonathan E. Alpert, MD, PhD, chair of the department of psychiatry and behavioral sciences and professor of psychiatry, neuroscience, and pediatrics at Albert Einstein College of Medicine, New York, said the investigational drug could represent an important addition to the armamentarium for treating depression.
“Zuranolone has good oral bioavailability and would represent the first neuroactive steroid antidepressant available in oral form and, indeed, the first non–monoamine-based antidepressant available in oral form,” he said in an interview.
Dr. Alpert was not involved in the research and has no relationship with the drug’s development.
He noted that although there are modest differences between the patients who received zuranolone and those who received placebo in the trials, “this may have been related to high placebo response rates, which often complicate antidepressant trials.
“Further research is needed to determine whether differences between zuranolone and placebo are clinically meaningful, though the separation between drug and placebo on the primary endpoint, as well as some other measures, such as quality of life measures, is promising,” Dr. Alpert said.
However, he added that comparisons with other active antidepressants in terms of efficacy and tolerability remain to be seen.
“Given the large number of individuals with major depressive disorder who have incomplete response to or do not tolerate monoaminergic antidepressants, the development of agents that leverage novel nonmonoaminergic mechanisms is important,” Dr. Alpert concluded.
The study was funded by Sage Therapeutics and Biogen. Dr. Cutler has been involved in research of zuranolone for Sage Therapeutics. Dr. Alpert has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DENVER –
In a phase 3 trial that included more than 500 adult patients with MDD, those who received zuranolone for 14 days showed greater improvement at day 15 across numerous QoL outcomes, compared with their counterparts in the placebo group.
In addition, combined analysis of four zuranolone clinical trials showed “mental well-being and functioning improved to near general population norm levels” for the active-treatment group, reported the researchers, led by Anita H. Clayton, MD, chair and professor of psychiatry, University of Virginia, Charlottesville.
“Based on these integrated analyses, the benefit of treatment with zuranolone may extend beyond reduction in depressive symptoms to include potential improvement in quality of life and overall health, as perceived by patients,” they add.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
First oral formulation
Zuranolone represents the second entry in the new class of neuroactive steroid drugs, which modulate GABA-A receptor activity – but it would be the first to have an oral formulation. Brexanolone, which was approved by the Food and Drug Administration in 2019 for postpartum depression, is administered through continuous IV infusion over 60 hours.
As previously reported by this news organization, zuranolone improved depressive symptoms as early as day 3, achieving the primary endpoint of significantly greater reduction in scores on the 17-item Hamilton Rating Scale for Depression from baseline to day 15 versus placebo (P = .014).
In the new analysis, patient-reported measures of functional health and well-being were assessed in the WATERFALL trial. It included 266 patients with MDD who were treated with zuranolone 50 mg daily for 2 weeks and 268 patients with MDD who were treated with placebo.
The study used the Short Form–36 (SF-36v2), which covers a wide range of patient-reported measures, including physical function, bodily pain, general health, vitality, social function, and “role-emotional” symptoms.
Results showed that although the treatment and placebo groups had similar baseline SF-36v2 scores, those receiving zuranolone reported significantly greater improvements at day 15 in almost all of the assessment’s domains, including physical function (treatment difference, 0.8), general health (1.0), vitality (3.1), social functioning (1.1), and role-emotional symptoms (1.5; for all comparisons, P < .05). The only exceptions were in role-physical symptoms and bodily pain.
In measures that included physical function, bodily pain, and general health, the patients achieved improvements at day 15 that were consistent with normal levels, with the improvement in vitality considered clinically meaningful versus placebo.
Integrated data
In further analysis of integrated data from four zuranolone clinical trials in the NEST and LANDSCAPE programs for patients with MDD and postpartum depression, results showed similar improvements at day 15 for zuranolone in QoL and overall health across all of the SF-36v2 functioning and well-being domains (P <.05), with the exceptions of physical measure and bodily pain.
By day 42, all of the domains showed significantly greater improvement with zuranolone versus placebo (all, P <.05).
Among the strongest score improvements in the integrated trials were measures in social functioning, which improved from baseline scores of 29.66 to 42.82 on day 15 and to 43.59 on day 42.
Emotional domain scores improved from 24.43 at baseline to 39.13 on day 15 and to 39.82 on day 42. For mental health, the integrated scores for the zuranolone group improved from 27.13 at baseline to 42.40 on day 15 and 42.62 on day 42.
Of note, the baseline scores for mental health represented just 54.3% of those in the normal population; with the increase at day 15, the level was 84.8% of the normal population.
“Across four completed placebo-controlled NEST and LANDSCAPE clinical trials, patient reports of functional health and well-being as assessed by the SF-36v2 indicated substantial impairment at baseline compared to the population norm,” the researchers reported.
The improvements are especially important in light of the fact that in some patients with MDD, functional improvement is a top priority.
“Patients have often prioritized returning to their usual level of functioning over reduction in depressive symptoms, and functional recovery has been associated with better prognosis of depression,” the investigators wrote.
Zuranolone trials have shown that treatment-emergent adverse events (AEs) occur among about 60% of patients, versus about 44% with placebo. The most common AEs are somnolence, dizziness, headache, sedation, and diarrhea, with no increases in suicidal ideation or withdrawal.
The rates of severe AEs are low, and they are observed in about 3% of patients, versus 1.1% with placebo, the researchers noted.
Further, as opposed to serotonergic antidepressants such as SNRIs and SSRIs, zuranolone does not appear to have the undesirable side effects of decreased libido and sexual dysfunction, they added.
Clinically meaningful?
Andrew J. Cutler, MD, clinical associate professor of psychiatry at State University of New York, Syracuse, said the data are “very significant” for a number of reasons.
“We need more options to treat depression, especially ones with novel mechanisms of action and faster onset of efficacy, such as zuranolone,” said Dr. Cutler, who was not involved in the current study. He has coauthored other studies on zuranolone.
Regarding the study’s QoL outcomes, “while improvement in depressive symptoms is very important, what really matters to patients is improvement in function and quality of life,” Dr. Cutler noted.
Also commenting on the study, Jonathan E. Alpert, MD, PhD, chair of the department of psychiatry and behavioral sciences and professor of psychiatry, neuroscience, and pediatrics at Albert Einstein College of Medicine, New York, said the investigational drug could represent an important addition to the armamentarium for treating depression.
“Zuranolone has good oral bioavailability and would represent the first neuroactive steroid antidepressant available in oral form and, indeed, the first non–monoamine-based antidepressant available in oral form,” he said in an interview.
Dr. Alpert was not involved in the research and has no relationship with the drug’s development.
He noted that although there are modest differences between the patients who received zuranolone and those who received placebo in the trials, “this may have been related to high placebo response rates, which often complicate antidepressant trials.
“Further research is needed to determine whether differences between zuranolone and placebo are clinically meaningful, though the separation between drug and placebo on the primary endpoint, as well as some other measures, such as quality of life measures, is promising,” Dr. Alpert said.
However, he added that comparisons with other active antidepressants in terms of efficacy and tolerability remain to be seen.
“Given the large number of individuals with major depressive disorder who have incomplete response to or do not tolerate monoaminergic antidepressants, the development of agents that leverage novel nonmonoaminergic mechanisms is important,” Dr. Alpert concluded.
The study was funded by Sage Therapeutics and Biogen. Dr. Cutler has been involved in research of zuranolone for Sage Therapeutics. Dr. Alpert has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ADAA 2022
Progressive muscle relaxation outperforms mindfulness in reducing grief severity
DENVER –
“Both progressive muscle relaxation and mindfulness training were shown to improve grief severity, yearning, depression symptoms, and stress, [but] the results from this study suggest that progressive muscle relaxation is most effective, compared to a wait-list control condition for improving grief,” study investigator Lindsey Knowles, PhD, senior fellow, MS Center of Excellence, Veterans Affairs Puget Sound Health Care System, and University of Washington, Seattle, told this news organization.
“With replication, progressive muscle relaxation could be a standalone intervention for nondisordered grief or a component of treatment for disordered grief,” Dr. Knowles said.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Disordered grief
Approximately 10% of individuals grappling with loss “get stuck” in their grief and develop disordered grief, which is distinguished by repetitive thought processes of yearning and grief rumination, the investigators noted.
The researchers hypothesized that mindfulness training, which has been shown to reduce maladaptive repetitive thought, could be an effective intervention to prevent disordered grief.
To investigate, they enrolled 94 widows and widowers (mean age, 67.5 years) who were experiencing bereavement-related grief and were between 6 months and 4 years post loss.
The researchers compared a 6-week mindfulness intervention (n = 37) with a 6-week progressive muscle relaxation intervention (n = 35), Dr. Knowles said, because there has been speculation that benefits from mindfulness training may be related more to the relaxation response than to the actual mindfulness component.
Both study groups received the intervention in similar settings with matched instructors.
The mindfulness intervention sessions included 10-25 minutes of meditation and mindfulness practices. It also included instructions for home practice.
Participants in the progressive muscle relaxation group were trained to tense and relax the body’s various muscle groups with an end goal of learning to relax four key muscle groups without initial tensing.
A third group of patients were placed on a wait list with no intervention (n = 22).
Measures taken throughout the study interventions and at 1 month postintervention showed reductions in the study’s two primary outcomes of grief severity and yearning for both interventions versus baseline (P = < .003).
However, only the progressive muscle relaxation group had a significantly greater reduction in grief severity vs the wait-list control group (P = .020).
The muscle relaxation group also showed lower grief severity at 1month follow-up versus the wait-list group (P = .049) – with a value at that time falling below an established cutoff for complicated grief, based on the Revised Inventory of Complicated Grief.
All three treatment groups showed a drop in the third primary outcome of grief rumination (P < .001).
Secondary outcomes of depression and stress were reduced in both active study groups versus the wait-list group (P = .028). Sleep quality also improved in both active intervention groups.
Simple technique
Dr. Knowles said the study’s findings were unexpected.
“We had hypothesized that mindfulness training would outperform progressive muscle relaxation and wait-list for improving grief outcomes,” she said.
Mindfulness experts underscore that a state of global relaxation is considered integral to the benefits of mindfulness, which could explain the benefits of progressive muscle relaxation, Dr. Knowles noted.
Importantly, progressive muscle relaxation has a key advantage: It is quickly and easily learned, which may partially explain the study’s findings, she added.
“Progressive muscle relaxation is a relatively simple technique, so it is also likely that participants were able to master [the technique] over the 6-week intervention,” Dr. Knowles said. “On the other hand, the mindfulness intervention was an introduction to mindfulness, and mastery was not expected or likely over the 6-week intervention.”
Either way, the results shed important light on a potentially beneficial grief intervention.
“Although mindfulness training and progressive muscle relaxation practices may both be perceived as relaxing, mastering progressive muscle relaxation may in fact enable people to maintain better focus in the present moment and generalize nonreactive awareness to both positively and negatively balanced phenomena,” Dr. Knowles said.
However, “more research is necessary to clarify how progressive muscle relaxation improves grief outcomes in widows and widowers.”
CNS benefits?
Zoe Donaldson, PhD, assistant professor in behavioral neuroscience, department of psychology and neuroscience, University of Colorado, Boulder, said the study is important for ongoing efforts in finding effective therapies for grief.
“We often struggle to try to help those experiencing the pain of loss and this study suggests a discrete set of exercises that may help,” said Dr. Donaldson, who was not involved with the research.
She also described the study results as surprising, and speculated that a combination of factors could explain the findings.
“First, mindfulness is hard to achieve, so the moderate beneficial effects might increase with more substantial mindfulness training. Secondly, it is not clear why progressive muscle relaxation had an effect, but the focus and attention to detail may engage the central nervous system in a beneficial way that we don’t fully understand,” Dr. Donaldson said.
Importantly, it’s key to remember that grief is an individual condition when investigating therapies, Dr. Donaldson noted.
“We likely need to develop multiple interventions to help those who are grieving. Incorporating loss can take many forms,” she said.
The investigators and Dr. Donaldson reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DENVER –
“Both progressive muscle relaxation and mindfulness training were shown to improve grief severity, yearning, depression symptoms, and stress, [but] the results from this study suggest that progressive muscle relaxation is most effective, compared to a wait-list control condition for improving grief,” study investigator Lindsey Knowles, PhD, senior fellow, MS Center of Excellence, Veterans Affairs Puget Sound Health Care System, and University of Washington, Seattle, told this news organization.
“With replication, progressive muscle relaxation could be a standalone intervention for nondisordered grief or a component of treatment for disordered grief,” Dr. Knowles said.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Disordered grief
Approximately 10% of individuals grappling with loss “get stuck” in their grief and develop disordered grief, which is distinguished by repetitive thought processes of yearning and grief rumination, the investigators noted.
The researchers hypothesized that mindfulness training, which has been shown to reduce maladaptive repetitive thought, could be an effective intervention to prevent disordered grief.
To investigate, they enrolled 94 widows and widowers (mean age, 67.5 years) who were experiencing bereavement-related grief and were between 6 months and 4 years post loss.
The researchers compared a 6-week mindfulness intervention (n = 37) with a 6-week progressive muscle relaxation intervention (n = 35), Dr. Knowles said, because there has been speculation that benefits from mindfulness training may be related more to the relaxation response than to the actual mindfulness component.
Both study groups received the intervention in similar settings with matched instructors.
The mindfulness intervention sessions included 10-25 minutes of meditation and mindfulness practices. It also included instructions for home practice.
Participants in the progressive muscle relaxation group were trained to tense and relax the body’s various muscle groups with an end goal of learning to relax four key muscle groups without initial tensing.
A third group of patients were placed on a wait list with no intervention (n = 22).
Measures taken throughout the study interventions and at 1 month postintervention showed reductions in the study’s two primary outcomes of grief severity and yearning for both interventions versus baseline (P = < .003).
However, only the progressive muscle relaxation group had a significantly greater reduction in grief severity vs the wait-list control group (P = .020).
The muscle relaxation group also showed lower grief severity at 1month follow-up versus the wait-list group (P = .049) – with a value at that time falling below an established cutoff for complicated grief, based on the Revised Inventory of Complicated Grief.
All three treatment groups showed a drop in the third primary outcome of grief rumination (P < .001).
Secondary outcomes of depression and stress were reduced in both active study groups versus the wait-list group (P = .028). Sleep quality also improved in both active intervention groups.
Simple technique
Dr. Knowles said the study’s findings were unexpected.
“We had hypothesized that mindfulness training would outperform progressive muscle relaxation and wait-list for improving grief outcomes,” she said.
Mindfulness experts underscore that a state of global relaxation is considered integral to the benefits of mindfulness, which could explain the benefits of progressive muscle relaxation, Dr. Knowles noted.
Importantly, progressive muscle relaxation has a key advantage: It is quickly and easily learned, which may partially explain the study’s findings, she added.
“Progressive muscle relaxation is a relatively simple technique, so it is also likely that participants were able to master [the technique] over the 6-week intervention,” Dr. Knowles said. “On the other hand, the mindfulness intervention was an introduction to mindfulness, and mastery was not expected or likely over the 6-week intervention.”
Either way, the results shed important light on a potentially beneficial grief intervention.
“Although mindfulness training and progressive muscle relaxation practices may both be perceived as relaxing, mastering progressive muscle relaxation may in fact enable people to maintain better focus in the present moment and generalize nonreactive awareness to both positively and negatively balanced phenomena,” Dr. Knowles said.
However, “more research is necessary to clarify how progressive muscle relaxation improves grief outcomes in widows and widowers.”
CNS benefits?
Zoe Donaldson, PhD, assistant professor in behavioral neuroscience, department of psychology and neuroscience, University of Colorado, Boulder, said the study is important for ongoing efforts in finding effective therapies for grief.
“We often struggle to try to help those experiencing the pain of loss and this study suggests a discrete set of exercises that may help,” said Dr. Donaldson, who was not involved with the research.
She also described the study results as surprising, and speculated that a combination of factors could explain the findings.
“First, mindfulness is hard to achieve, so the moderate beneficial effects might increase with more substantial mindfulness training. Secondly, it is not clear why progressive muscle relaxation had an effect, but the focus and attention to detail may engage the central nervous system in a beneficial way that we don’t fully understand,” Dr. Donaldson said.
Importantly, it’s key to remember that grief is an individual condition when investigating therapies, Dr. Donaldson noted.
“We likely need to develop multiple interventions to help those who are grieving. Incorporating loss can take many forms,” she said.
The investigators and Dr. Donaldson reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DENVER –
“Both progressive muscle relaxation and mindfulness training were shown to improve grief severity, yearning, depression symptoms, and stress, [but] the results from this study suggest that progressive muscle relaxation is most effective, compared to a wait-list control condition for improving grief,” study investigator Lindsey Knowles, PhD, senior fellow, MS Center of Excellence, Veterans Affairs Puget Sound Health Care System, and University of Washington, Seattle, told this news organization.
“With replication, progressive muscle relaxation could be a standalone intervention for nondisordered grief or a component of treatment for disordered grief,” Dr. Knowles said.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Disordered grief
Approximately 10% of individuals grappling with loss “get stuck” in their grief and develop disordered grief, which is distinguished by repetitive thought processes of yearning and grief rumination, the investigators noted.
The researchers hypothesized that mindfulness training, which has been shown to reduce maladaptive repetitive thought, could be an effective intervention to prevent disordered grief.
To investigate, they enrolled 94 widows and widowers (mean age, 67.5 years) who were experiencing bereavement-related grief and were between 6 months and 4 years post loss.
The researchers compared a 6-week mindfulness intervention (n = 37) with a 6-week progressive muscle relaxation intervention (n = 35), Dr. Knowles said, because there has been speculation that benefits from mindfulness training may be related more to the relaxation response than to the actual mindfulness component.
Both study groups received the intervention in similar settings with matched instructors.
The mindfulness intervention sessions included 10-25 minutes of meditation and mindfulness practices. It also included instructions for home practice.
Participants in the progressive muscle relaxation group were trained to tense and relax the body’s various muscle groups with an end goal of learning to relax four key muscle groups without initial tensing.
A third group of patients were placed on a wait list with no intervention (n = 22).
Measures taken throughout the study interventions and at 1 month postintervention showed reductions in the study’s two primary outcomes of grief severity and yearning for both interventions versus baseline (P = < .003).
However, only the progressive muscle relaxation group had a significantly greater reduction in grief severity vs the wait-list control group (P = .020).
The muscle relaxation group also showed lower grief severity at 1month follow-up versus the wait-list group (P = .049) – with a value at that time falling below an established cutoff for complicated grief, based on the Revised Inventory of Complicated Grief.
All three treatment groups showed a drop in the third primary outcome of grief rumination (P < .001).
Secondary outcomes of depression and stress were reduced in both active study groups versus the wait-list group (P = .028). Sleep quality also improved in both active intervention groups.
Simple technique
Dr. Knowles said the study’s findings were unexpected.
“We had hypothesized that mindfulness training would outperform progressive muscle relaxation and wait-list for improving grief outcomes,” she said.
Mindfulness experts underscore that a state of global relaxation is considered integral to the benefits of mindfulness, which could explain the benefits of progressive muscle relaxation, Dr. Knowles noted.
Importantly, progressive muscle relaxation has a key advantage: It is quickly and easily learned, which may partially explain the study’s findings, she added.
“Progressive muscle relaxation is a relatively simple technique, so it is also likely that participants were able to master [the technique] over the 6-week intervention,” Dr. Knowles said. “On the other hand, the mindfulness intervention was an introduction to mindfulness, and mastery was not expected or likely over the 6-week intervention.”
Either way, the results shed important light on a potentially beneficial grief intervention.
“Although mindfulness training and progressive muscle relaxation practices may both be perceived as relaxing, mastering progressive muscle relaxation may in fact enable people to maintain better focus in the present moment and generalize nonreactive awareness to both positively and negatively balanced phenomena,” Dr. Knowles said.
However, “more research is necessary to clarify how progressive muscle relaxation improves grief outcomes in widows and widowers.”
CNS benefits?
Zoe Donaldson, PhD, assistant professor in behavioral neuroscience, department of psychology and neuroscience, University of Colorado, Boulder, said the study is important for ongoing efforts in finding effective therapies for grief.
“We often struggle to try to help those experiencing the pain of loss and this study suggests a discrete set of exercises that may help,” said Dr. Donaldson, who was not involved with the research.
She also described the study results as surprising, and speculated that a combination of factors could explain the findings.
“First, mindfulness is hard to achieve, so the moderate beneficial effects might increase with more substantial mindfulness training. Secondly, it is not clear why progressive muscle relaxation had an effect, but the focus and attention to detail may engage the central nervous system in a beneficial way that we don’t fully understand,” Dr. Donaldson said.
Importantly, it’s key to remember that grief is an individual condition when investigating therapies, Dr. Donaldson noted.
“We likely need to develop multiple interventions to help those who are grieving. Incorporating loss can take many forms,” she said.
The investigators and Dr. Donaldson reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ADAA 2022
High-intensity exercise helps patients with anxiety quit smoking
DENVER –
Results from a randomized study of 150 participants reporting symptoms of anxiety showed that among daily smokers who received a personalized, high-intensity aerobic intervention, rates of smoking abstinence were nearly twice as great as for those who received a lower-intensity exercise intervention.
“We are encouraged in the sense that we feel we have a targeted [smoking cessation] intervention to tailor to people with high anxiety sensitivity,” lead author Jasper A. Smits, PhD, professor at the Institute for Mental Health Research and the department of psychology, the University of Texas at Austin, told attendees during a presentation of the findings at the Anxiety and Depression Association of America (ADAA) 2022. The findings were recently published in Addiction.
Effective as CBT
Previous research shows that relatively short periods of exercise, lasting as little as 2 weeks, were associated with reductions in anxiety equivalent to 12 weeks of cognitive-behavioral therapy (CBT).
In light of these earlier findings, Dr. Smits and colleagues investigated the effect of an exercise intervention for smoking cessation based on the knowledge that individuals with anxiety disorders are more likely to smoke and less likely to succeed in quitting.
The initial study, which was published in 2016, included 136 smokers with high “anxiety sensitivity,” a heightened sensitivity to normal sensations associated with anxiety, potentially leading to panic attacks or other disorders.
Results showed that participation in the researchers’ Smoking Treatment Enhancement Program (STEP) was associated with significant improvements in prolonged smoking abstinence among those with high anxiety sensitivity but not those with low anxiety.
Building on these results, the new study evaluated the exercise program at a community level at four YMCA centers. This time all participants had high anxiety sensitivity, defined as a score of 23 or higher on the Anxiety Sensitivity Index–3.
The study included 150 adult participants who had high anxiety, were daily smokers, were motivated to quit smoking, and who reported that they did not currently participate in regular moderate exercise.
All participants (67.3% women; mean age, 38.6 years) took part in STEP, which included a 15-week exercise intervention with a personal trainer. Of the participants, 77 individuals were randomly assigned to receive high-intensity aerobic training that targeted 60%-85% of their heart rate reserve (HRR), while the other 73 were assigned to a lower-intensity control group in which training was only targeted to 20%-40% of their HRR.
All participants also received standard behavioral support with phone- or text-based CBT and nicotine replacement therapy (NRT).
The centers’ fitness instructors served as case managers who oversaw the smoking cessation exercise regimens of high-intensity versus low-intensity exercise. A broad array of aerobic exercise options were permitted, with the instructors working with participants to personalize their regimens.
“It’s important to take into consideration patients’ preferences [and] to work with the fitness instructors to find the right activity,” Dr. Smits said. He noted that options may include intense yoga or swimming. “So I think we just need to be creative in thinking about exercise as being more than just running,” he noted.
Abstinence rate doubled
The study’s primary endpoint was abstinence, defined as biologically verified 7-day point prevalence abstinence.
Results at 6-month follow-up showed that the primary endpoint was achieved by 27.6% of the higher-intensity intervention group, compared with just 14.8% of the lower-intensity group (odds ratio, 2.2; P = .005).
“It was encouraging to see we roughly doubled the abstinence rate at the 6-month follow-up,” Dr. Smits said. “Those receiving the high-intensity exercise intervention had greater abstinence rates spanning the entire study period versus the standard treatment.”
Of note, declines in anxiety sensitivity, as measured on the Reiss-Epstein-Gursky Anxiety Sensitivity Index, were observed in both groups. However, there was no significant difference in changes between the two groups.
Dr. Smits noted the investigators initially speculated that exercise would improve cessation success in individuals with anxiety sensitivity by providing exposure to the types of sensations that may trigger their anxiety, such as sweating and an accelerated heart rate, providing an opportunity for “extinction training” by desensitizing them to these experiences.
In addition, high-intensity exercise may also mitigate other anxiety symptoms, including panic disorder, pain, depression, overeating, and posttraumatic stress disorder, Dr. Smits said.
Real-world evidence
Commenting on the findings, Sahib S. Khalsa, MD, PhD, director of clinical operations at the Laureate Institute for Brain Research and associate professor at the University of Tulsa, Oklahoma, noted that the real-world nature of the study suggests its results are widely applicable.
It is also important to note that both the current and previous studies conducted by the investigators included NRT, “and thus the effects are more likely to be reflective of a grouping of therapies, something that is more reflective of current practice,” said Dr. Khalsa, who was not involved in the research.
He noted that initiating as well as maintaining exercise motivation over longer periods is challenging.
“The study likely addressed this challenge by using fitness instructors, which may be an important criterion for successful deployment of the intervention. We also don’t know whether maintaining an active exercise regimen is critical to maintaining smoking cessation,” Dr. Khalsa added.
Dr. Smits is a consultant for Big Health. Dr. Khalsa has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DENVER –
Results from a randomized study of 150 participants reporting symptoms of anxiety showed that among daily smokers who received a personalized, high-intensity aerobic intervention, rates of smoking abstinence were nearly twice as great as for those who received a lower-intensity exercise intervention.
“We are encouraged in the sense that we feel we have a targeted [smoking cessation] intervention to tailor to people with high anxiety sensitivity,” lead author Jasper A. Smits, PhD, professor at the Institute for Mental Health Research and the department of psychology, the University of Texas at Austin, told attendees during a presentation of the findings at the Anxiety and Depression Association of America (ADAA) 2022. The findings were recently published in Addiction.
Effective as CBT
Previous research shows that relatively short periods of exercise, lasting as little as 2 weeks, were associated with reductions in anxiety equivalent to 12 weeks of cognitive-behavioral therapy (CBT).
In light of these earlier findings, Dr. Smits and colleagues investigated the effect of an exercise intervention for smoking cessation based on the knowledge that individuals with anxiety disorders are more likely to smoke and less likely to succeed in quitting.
The initial study, which was published in 2016, included 136 smokers with high “anxiety sensitivity,” a heightened sensitivity to normal sensations associated with anxiety, potentially leading to panic attacks or other disorders.
Results showed that participation in the researchers’ Smoking Treatment Enhancement Program (STEP) was associated with significant improvements in prolonged smoking abstinence among those with high anxiety sensitivity but not those with low anxiety.
Building on these results, the new study evaluated the exercise program at a community level at four YMCA centers. This time all participants had high anxiety sensitivity, defined as a score of 23 or higher on the Anxiety Sensitivity Index–3.
The study included 150 adult participants who had high anxiety, were daily smokers, were motivated to quit smoking, and who reported that they did not currently participate in regular moderate exercise.
All participants (67.3% women; mean age, 38.6 years) took part in STEP, which included a 15-week exercise intervention with a personal trainer. Of the participants, 77 individuals were randomly assigned to receive high-intensity aerobic training that targeted 60%-85% of their heart rate reserve (HRR), while the other 73 were assigned to a lower-intensity control group in which training was only targeted to 20%-40% of their HRR.
All participants also received standard behavioral support with phone- or text-based CBT and nicotine replacement therapy (NRT).
The centers’ fitness instructors served as case managers who oversaw the smoking cessation exercise regimens of high-intensity versus low-intensity exercise. A broad array of aerobic exercise options were permitted, with the instructors working with participants to personalize their regimens.
“It’s important to take into consideration patients’ preferences [and] to work with the fitness instructors to find the right activity,” Dr. Smits said. He noted that options may include intense yoga or swimming. “So I think we just need to be creative in thinking about exercise as being more than just running,” he noted.
Abstinence rate doubled
The study’s primary endpoint was abstinence, defined as biologically verified 7-day point prevalence abstinence.
Results at 6-month follow-up showed that the primary endpoint was achieved by 27.6% of the higher-intensity intervention group, compared with just 14.8% of the lower-intensity group (odds ratio, 2.2; P = .005).
“It was encouraging to see we roughly doubled the abstinence rate at the 6-month follow-up,” Dr. Smits said. “Those receiving the high-intensity exercise intervention had greater abstinence rates spanning the entire study period versus the standard treatment.”
Of note, declines in anxiety sensitivity, as measured on the Reiss-Epstein-Gursky Anxiety Sensitivity Index, were observed in both groups. However, there was no significant difference in changes between the two groups.
Dr. Smits noted the investigators initially speculated that exercise would improve cessation success in individuals with anxiety sensitivity by providing exposure to the types of sensations that may trigger their anxiety, such as sweating and an accelerated heart rate, providing an opportunity for “extinction training” by desensitizing them to these experiences.
In addition, high-intensity exercise may also mitigate other anxiety symptoms, including panic disorder, pain, depression, overeating, and posttraumatic stress disorder, Dr. Smits said.
Real-world evidence
Commenting on the findings, Sahib S. Khalsa, MD, PhD, director of clinical operations at the Laureate Institute for Brain Research and associate professor at the University of Tulsa, Oklahoma, noted that the real-world nature of the study suggests its results are widely applicable.
It is also important to note that both the current and previous studies conducted by the investigators included NRT, “and thus the effects are more likely to be reflective of a grouping of therapies, something that is more reflective of current practice,” said Dr. Khalsa, who was not involved in the research.
He noted that initiating as well as maintaining exercise motivation over longer periods is challenging.
“The study likely addressed this challenge by using fitness instructors, which may be an important criterion for successful deployment of the intervention. We also don’t know whether maintaining an active exercise regimen is critical to maintaining smoking cessation,” Dr. Khalsa added.
Dr. Smits is a consultant for Big Health. Dr. Khalsa has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DENVER –
Results from a randomized study of 150 participants reporting symptoms of anxiety showed that among daily smokers who received a personalized, high-intensity aerobic intervention, rates of smoking abstinence were nearly twice as great as for those who received a lower-intensity exercise intervention.
“We are encouraged in the sense that we feel we have a targeted [smoking cessation] intervention to tailor to people with high anxiety sensitivity,” lead author Jasper A. Smits, PhD, professor at the Institute for Mental Health Research and the department of psychology, the University of Texas at Austin, told attendees during a presentation of the findings at the Anxiety and Depression Association of America (ADAA) 2022. The findings were recently published in Addiction.
Effective as CBT
Previous research shows that relatively short periods of exercise, lasting as little as 2 weeks, were associated with reductions in anxiety equivalent to 12 weeks of cognitive-behavioral therapy (CBT).
In light of these earlier findings, Dr. Smits and colleagues investigated the effect of an exercise intervention for smoking cessation based on the knowledge that individuals with anxiety disorders are more likely to smoke and less likely to succeed in quitting.
The initial study, which was published in 2016, included 136 smokers with high “anxiety sensitivity,” a heightened sensitivity to normal sensations associated with anxiety, potentially leading to panic attacks or other disorders.
Results showed that participation in the researchers’ Smoking Treatment Enhancement Program (STEP) was associated with significant improvements in prolonged smoking abstinence among those with high anxiety sensitivity but not those with low anxiety.
Building on these results, the new study evaluated the exercise program at a community level at four YMCA centers. This time all participants had high anxiety sensitivity, defined as a score of 23 or higher on the Anxiety Sensitivity Index–3.
The study included 150 adult participants who had high anxiety, were daily smokers, were motivated to quit smoking, and who reported that they did not currently participate in regular moderate exercise.
All participants (67.3% women; mean age, 38.6 years) took part in STEP, which included a 15-week exercise intervention with a personal trainer. Of the participants, 77 individuals were randomly assigned to receive high-intensity aerobic training that targeted 60%-85% of their heart rate reserve (HRR), while the other 73 were assigned to a lower-intensity control group in which training was only targeted to 20%-40% of their HRR.
All participants also received standard behavioral support with phone- or text-based CBT and nicotine replacement therapy (NRT).
The centers’ fitness instructors served as case managers who oversaw the smoking cessation exercise regimens of high-intensity versus low-intensity exercise. A broad array of aerobic exercise options were permitted, with the instructors working with participants to personalize their regimens.
“It’s important to take into consideration patients’ preferences [and] to work with the fitness instructors to find the right activity,” Dr. Smits said. He noted that options may include intense yoga or swimming. “So I think we just need to be creative in thinking about exercise as being more than just running,” he noted.
Abstinence rate doubled
The study’s primary endpoint was abstinence, defined as biologically verified 7-day point prevalence abstinence.
Results at 6-month follow-up showed that the primary endpoint was achieved by 27.6% of the higher-intensity intervention group, compared with just 14.8% of the lower-intensity group (odds ratio, 2.2; P = .005).
“It was encouraging to see we roughly doubled the abstinence rate at the 6-month follow-up,” Dr. Smits said. “Those receiving the high-intensity exercise intervention had greater abstinence rates spanning the entire study period versus the standard treatment.”
Of note, declines in anxiety sensitivity, as measured on the Reiss-Epstein-Gursky Anxiety Sensitivity Index, were observed in both groups. However, there was no significant difference in changes between the two groups.
Dr. Smits noted the investigators initially speculated that exercise would improve cessation success in individuals with anxiety sensitivity by providing exposure to the types of sensations that may trigger their anxiety, such as sweating and an accelerated heart rate, providing an opportunity for “extinction training” by desensitizing them to these experiences.
In addition, high-intensity exercise may also mitigate other anxiety symptoms, including panic disorder, pain, depression, overeating, and posttraumatic stress disorder, Dr. Smits said.
Real-world evidence
Commenting on the findings, Sahib S. Khalsa, MD, PhD, director of clinical operations at the Laureate Institute for Brain Research and associate professor at the University of Tulsa, Oklahoma, noted that the real-world nature of the study suggests its results are widely applicable.
It is also important to note that both the current and previous studies conducted by the investigators included NRT, “and thus the effects are more likely to be reflective of a grouping of therapies, something that is more reflective of current practice,” said Dr. Khalsa, who was not involved in the research.
He noted that initiating as well as maintaining exercise motivation over longer periods is challenging.
“The study likely addressed this challenge by using fitness instructors, which may be an important criterion for successful deployment of the intervention. We also don’t know whether maintaining an active exercise regimen is critical to maintaining smoking cessation,” Dr. Khalsa added.
Dr. Smits is a consultant for Big Health. Dr. Khalsa has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ADAA 2022
‘Staggeringly high’ rates of psychiatric symptoms after COVID-19
DENVER – Neurocognitive and psychiatric symptoms of mental illness, including posttraumatic stress disorder, are alarmingly high among patients who have previously had COVID-19 – even among those who were not hospitalized with the virus, new research shows.
The findings are from an online survey of more than 800 respondents.
“Regardless of how long ago they had been infected with COVID-19, all respondents had persistent symptoms,” co-investigator Beth Patterson, MSc, adjunct clinical professor at McMaster University, MacAnxiety Research Centre, Hamilton, Ont., told this news organization.
“The take-home message for clinicians is to be aware that if you have patients who had COVID-19, it’s quite likely that they may also experience a psychiatric issue and that they may have reduced resilience and lower quality-of-life [issues],” Ms. Patterson said.
The survey results were presented here at the Anxiety and Depression Association of America (ADAA) Conference 2022.
100% report symptoms
The study included 827 respondents (81% women) to an online survey who had contracted COVID.
Using validated symptom severity scores, respondents were assessed for mental health and neurocognitive issues, as well as some physical and quality-of-life factors.
Remarkably, all participants (100%) reported having current, persistent symptoms of COVID. In addition, 88% (n = 729) reported persistent neurocognitive symptoms, even though only 15.5% reported they had been hospitalized for COVID.
Of those hospitalized, 28.9% were treated in the intensive care unit; 42.2% stayed in hospital for less than 1 week; and 13.3% remained hospitalized for at least 3 weeks.
Data were not available on how long it had been since the patients were diagnosed or hospitalized, but most participants (68%) said they had not returned to normal functioning since contracting COVID.
The most common persistent symptoms were fatigue (75.9%), brain fog (67.9%), difficulty concentrating (61%), and weakness (51.2%).
More than half of respondents reported neurocognitive symptoms, including poor memory (57.4%) and word-finding problems in processing information (46.9%). Only 11% reported no persistent neurocognitive symptoms.
A total of 41.7% of respondents reported anxiety using the Generalized Anxiety Disorder-7 (GAD-7) scale, and rates of depression were 61.4% as assessed with the Patient Health Questionnaire (PHQ-9).
Rates of probable posttraumatic stress disorder were 40.5% as assessed via the PTSD checklist (PCL-5).
Although it wasn’t possible to use diagnostic screens, the assessment scores suggest strikingly high rates of mental health disorders among the respondents, Ms. Patterson said.
“When we look at the mean scores on the validated scales, we see percentages of probable diagnoses that are staggeringly higher than you would find in the population,” she added.
Of note, about 44% of respondents reported having had mental health treatment in the past, and 33.7% were receiving current mental health treatment.
Although the study had no control group, the findings are consistent with larger studies that have had comparator groups, including research recently published in the BMJ.
Poor understanding of COVID’s fallout
In an editorial accompanying the BMJ study, Scott Weich, MD, Mental Health Research Unit, School of Health and Related Research, University of Sheffield, United Kingdom, emphasized the need to better understand the lingering mental health aspects of COVID-19 infection.
“Our attachment to syndromal phenotypes means that we have learned remarkably little about the causes of mental ill health – in this case psychopathology associated with a viral pandemic,” Dr. Weich writes.
Dr. Weich called for improved efforts to understanding long COVID, as well as the establishment of more effective responses to the mental health fallout from the pandemic.
Commenting on the current study, Dr. Weich elaborated on the challenges in disentangling the causes of mental health effects in illness.
“In terms of other viruses, etc., there is a long history of debate and pitched battles between those that attribute mental health effects to predominantly biological processes, [involving] immunological and other responses, and those who understand these responses are mediated by psychological and social processes,” he noted.
“The story of myalgic encephalomyelitis/chronic fatigue syndrome speaks volumes about these different positions, and how difficult it can be to find a middle ground,” he said.
“This has been going on for centuries and may never be fully resolved, at least until we have clearer and more definitive evidence of pathophysiology, though this seems incredibly elusive,” Dr. Weich said.
The authors and Dr. Weich have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DENVER – Neurocognitive and psychiatric symptoms of mental illness, including posttraumatic stress disorder, are alarmingly high among patients who have previously had COVID-19 – even among those who were not hospitalized with the virus, new research shows.
The findings are from an online survey of more than 800 respondents.
“Regardless of how long ago they had been infected with COVID-19, all respondents had persistent symptoms,” co-investigator Beth Patterson, MSc, adjunct clinical professor at McMaster University, MacAnxiety Research Centre, Hamilton, Ont., told this news organization.
“The take-home message for clinicians is to be aware that if you have patients who had COVID-19, it’s quite likely that they may also experience a psychiatric issue and that they may have reduced resilience and lower quality-of-life [issues],” Ms. Patterson said.
The survey results were presented here at the Anxiety and Depression Association of America (ADAA) Conference 2022.
100% report symptoms
The study included 827 respondents (81% women) to an online survey who had contracted COVID.
Using validated symptom severity scores, respondents were assessed for mental health and neurocognitive issues, as well as some physical and quality-of-life factors.
Remarkably, all participants (100%) reported having current, persistent symptoms of COVID. In addition, 88% (n = 729) reported persistent neurocognitive symptoms, even though only 15.5% reported they had been hospitalized for COVID.
Of those hospitalized, 28.9% were treated in the intensive care unit; 42.2% stayed in hospital for less than 1 week; and 13.3% remained hospitalized for at least 3 weeks.
Data were not available on how long it had been since the patients were diagnosed or hospitalized, but most participants (68%) said they had not returned to normal functioning since contracting COVID.
The most common persistent symptoms were fatigue (75.9%), brain fog (67.9%), difficulty concentrating (61%), and weakness (51.2%).
More than half of respondents reported neurocognitive symptoms, including poor memory (57.4%) and word-finding problems in processing information (46.9%). Only 11% reported no persistent neurocognitive symptoms.
A total of 41.7% of respondents reported anxiety using the Generalized Anxiety Disorder-7 (GAD-7) scale, and rates of depression were 61.4% as assessed with the Patient Health Questionnaire (PHQ-9).
Rates of probable posttraumatic stress disorder were 40.5% as assessed via the PTSD checklist (PCL-5).
Although it wasn’t possible to use diagnostic screens, the assessment scores suggest strikingly high rates of mental health disorders among the respondents, Ms. Patterson said.
“When we look at the mean scores on the validated scales, we see percentages of probable diagnoses that are staggeringly higher than you would find in the population,” she added.
Of note, about 44% of respondents reported having had mental health treatment in the past, and 33.7% were receiving current mental health treatment.
Although the study had no control group, the findings are consistent with larger studies that have had comparator groups, including research recently published in the BMJ.
Poor understanding of COVID’s fallout
In an editorial accompanying the BMJ study, Scott Weich, MD, Mental Health Research Unit, School of Health and Related Research, University of Sheffield, United Kingdom, emphasized the need to better understand the lingering mental health aspects of COVID-19 infection.
“Our attachment to syndromal phenotypes means that we have learned remarkably little about the causes of mental ill health – in this case psychopathology associated with a viral pandemic,” Dr. Weich writes.
Dr. Weich called for improved efforts to understanding long COVID, as well as the establishment of more effective responses to the mental health fallout from the pandemic.
Commenting on the current study, Dr. Weich elaborated on the challenges in disentangling the causes of mental health effects in illness.
“In terms of other viruses, etc., there is a long history of debate and pitched battles between those that attribute mental health effects to predominantly biological processes, [involving] immunological and other responses, and those who understand these responses are mediated by psychological and social processes,” he noted.
“The story of myalgic encephalomyelitis/chronic fatigue syndrome speaks volumes about these different positions, and how difficult it can be to find a middle ground,” he said.
“This has been going on for centuries and may never be fully resolved, at least until we have clearer and more definitive evidence of pathophysiology, though this seems incredibly elusive,” Dr. Weich said.
The authors and Dr. Weich have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DENVER – Neurocognitive and psychiatric symptoms of mental illness, including posttraumatic stress disorder, are alarmingly high among patients who have previously had COVID-19 – even among those who were not hospitalized with the virus, new research shows.
The findings are from an online survey of more than 800 respondents.
“Regardless of how long ago they had been infected with COVID-19, all respondents had persistent symptoms,” co-investigator Beth Patterson, MSc, adjunct clinical professor at McMaster University, MacAnxiety Research Centre, Hamilton, Ont., told this news organization.
“The take-home message for clinicians is to be aware that if you have patients who had COVID-19, it’s quite likely that they may also experience a psychiatric issue and that they may have reduced resilience and lower quality-of-life [issues],” Ms. Patterson said.
The survey results were presented here at the Anxiety and Depression Association of America (ADAA) Conference 2022.
100% report symptoms
The study included 827 respondents (81% women) to an online survey who had contracted COVID.
Using validated symptom severity scores, respondents were assessed for mental health and neurocognitive issues, as well as some physical and quality-of-life factors.
Remarkably, all participants (100%) reported having current, persistent symptoms of COVID. In addition, 88% (n = 729) reported persistent neurocognitive symptoms, even though only 15.5% reported they had been hospitalized for COVID.
Of those hospitalized, 28.9% were treated in the intensive care unit; 42.2% stayed in hospital for less than 1 week; and 13.3% remained hospitalized for at least 3 weeks.
Data were not available on how long it had been since the patients were diagnosed or hospitalized, but most participants (68%) said they had not returned to normal functioning since contracting COVID.
The most common persistent symptoms were fatigue (75.9%), brain fog (67.9%), difficulty concentrating (61%), and weakness (51.2%).
More than half of respondents reported neurocognitive symptoms, including poor memory (57.4%) and word-finding problems in processing information (46.9%). Only 11% reported no persistent neurocognitive symptoms.
A total of 41.7% of respondents reported anxiety using the Generalized Anxiety Disorder-7 (GAD-7) scale, and rates of depression were 61.4% as assessed with the Patient Health Questionnaire (PHQ-9).
Rates of probable posttraumatic stress disorder were 40.5% as assessed via the PTSD checklist (PCL-5).
Although it wasn’t possible to use diagnostic screens, the assessment scores suggest strikingly high rates of mental health disorders among the respondents, Ms. Patterson said.
“When we look at the mean scores on the validated scales, we see percentages of probable diagnoses that are staggeringly higher than you would find in the population,” she added.
Of note, about 44% of respondents reported having had mental health treatment in the past, and 33.7% were receiving current mental health treatment.
Although the study had no control group, the findings are consistent with larger studies that have had comparator groups, including research recently published in the BMJ.
Poor understanding of COVID’s fallout
In an editorial accompanying the BMJ study, Scott Weich, MD, Mental Health Research Unit, School of Health and Related Research, University of Sheffield, United Kingdom, emphasized the need to better understand the lingering mental health aspects of COVID-19 infection.
“Our attachment to syndromal phenotypes means that we have learned remarkably little about the causes of mental ill health – in this case psychopathology associated with a viral pandemic,” Dr. Weich writes.
Dr. Weich called for improved efforts to understanding long COVID, as well as the establishment of more effective responses to the mental health fallout from the pandemic.
Commenting on the current study, Dr. Weich elaborated on the challenges in disentangling the causes of mental health effects in illness.
“In terms of other viruses, etc., there is a long history of debate and pitched battles between those that attribute mental health effects to predominantly biological processes, [involving] immunological and other responses, and those who understand these responses are mediated by psychological and social processes,” he noted.
“The story of myalgic encephalomyelitis/chronic fatigue syndrome speaks volumes about these different positions, and how difficult it can be to find a middle ground,” he said.
“This has been going on for centuries and may never be fully resolved, at least until we have clearer and more definitive evidence of pathophysiology, though this seems incredibly elusive,” Dr. Weich said.
The authors and Dr. Weich have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ADAA 2022
Executive-function deficits a new treatment target for PTSD?
DENVER –
“To our knowledge, this study is the first to show that executive-function deficits maintain PTSD symptoms following trauma exposure,” investigators noted in research presented at the Anxiety and Depression Association of America (ADAA) Anxiety & Depression conference.
The results are important in “developing precision medicine–based approaches for alleviating [posttraumatic stress] symptoms, and improving well-established PTSD treatments for those with relative deficits in executive function,” study investigator Joseph R. Bardeen, PhD, associate professor at Auburn (Ala.) University, told meeting attendees.
The findings were published in the Journal of Anxiety Disorders.
Cognitive impairment
In earlier research, deficits in EF were associated with an increased vulnerability for PTSD symptoms. However, less is known about the role of these deficits, which can impair higher-level cognitive ability, in sustaining PTSD symptoms.
To investigate, the authors conducted a longitudinal study that included 98 participants aged 18-65 years who had been identified via phone screening as experiencing clinically significant PTSD symptoms.
Participants completed self-report measures for PTSD symptoms, as well as measures for EF deficits at baseline and 6-month (n = 92) and 12-month (n = 91) follow-up sessions.
A path analysis showed a significant relationship between baseline PTSD symptoms and EF deficits at 6 months (P < .001). Baseline PTSD symptoms were associated with 12-month PTSD symptoms (P < .04).
EF deficits at 6 months were also associated with 12-month PTSD symptoms (P = .02).
Importantly, no associations were observed between baseline or 6-month PTSD symptoms and EF deficits at 12 months. However, EF deficits at 6 months drove the relationship between PTSD symptoms at baseline and at 1 year (indirect effect = .061).
“What this suggests is that executive-function deficits are a mechanism that maintains patients’ symptoms over the course of 1 year,” Dr. Bardeen said.
“And you don’t see the reverse,” he added. “You don’t see that PTSD symptoms at [6 months] mediate the relationship between [baseline] and 6 month executive-function deficits.”
Surprising finding
The findings suggest deficits in executive functioning have a stronger role in maintaining PTSD symptoms than these symptoms have in maintaining EF deficits, Dr. Bardeen told this news organization.
“I had originally hypothesized a bidirectional relationship in which PTSD symptoms influenced future executive-function deficits and executive-function deficits influenced future PTSD symptoms,” he said.
“So, it was a surprise that, when accounting for both variables in the same model, executive-function deficits predicted future PTSD symptoms, but PTSD symptoms did not significantly predict future EF deficits,” he added.
Dr. Bardeen noted this suggests that EF deficits “may be a particularly important maintenance factor.”
In addition, he recommended the use of neuropsychological assessments prior to treatment to identify individuals with EF deficits and distinguish those deficits from PTSD symptoms.
“There is certainly overlap between executive-function deficits and PTSD symptoms,” Dr. Bardeen said. “For example, several of the symptoms of PTSD, such as concentration difficulties, may be indicators of executive-function deficits.”
He noted assessments such as the Delis Kaplan Executive Function System, and Clinician Administered PTSD Scale for DSM-5, when used as part of a larger assessment battery, can help differentiate between the EF deficits and PTSD.
“This would take several hours to administer, but in cases in which serious cognitive impairment is suspected, a comprehensive assessment is the way to go,” Dr. Bardeen said.
The standard approaches of prolonged exposure therapy and cognitive processing therapy can be effective in patients without EF deficits, while some modifications may benefit those with these deficits, he added.
“For example, it’s important to provide a more directive and structured environment in which the practitioner repeats key points frequently, uses concrete language, simplifies worksheets, and provides written summaries and reminder cards,” he said.
Further findings
In additional research presented at the meeting, Elsa Mattson, a PhD student from Case Western Reserve University, Cleveland, and colleagues reported findings further distinguishing the role of EF in PTSD.
In that study of 149 patients with chronic PTSD, those with low performing working memory, but not high working memory, had higher pre- as well as posttreatment PTSD symptom severity and depressive symptoms.
“Clinicians should consider that impairments in executive function may play a role in reduced treatment response, potentially impairing a client’s ability to learn new information in treatment,” the investigators wrote.
“Understanding how executive function processes change over the course of treatment, particularly in relation to processing the trauma memories, is an important next step,” they added.
The first study was supported by a grant from the National Institute of Mental Health. The investigators have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DENVER –
“To our knowledge, this study is the first to show that executive-function deficits maintain PTSD symptoms following trauma exposure,” investigators noted in research presented at the Anxiety and Depression Association of America (ADAA) Anxiety & Depression conference.
The results are important in “developing precision medicine–based approaches for alleviating [posttraumatic stress] symptoms, and improving well-established PTSD treatments for those with relative deficits in executive function,” study investigator Joseph R. Bardeen, PhD, associate professor at Auburn (Ala.) University, told meeting attendees.
The findings were published in the Journal of Anxiety Disorders.
Cognitive impairment
In earlier research, deficits in EF were associated with an increased vulnerability for PTSD symptoms. However, less is known about the role of these deficits, which can impair higher-level cognitive ability, in sustaining PTSD symptoms.
To investigate, the authors conducted a longitudinal study that included 98 participants aged 18-65 years who had been identified via phone screening as experiencing clinically significant PTSD symptoms.
Participants completed self-report measures for PTSD symptoms, as well as measures for EF deficits at baseline and 6-month (n = 92) and 12-month (n = 91) follow-up sessions.
A path analysis showed a significant relationship between baseline PTSD symptoms and EF deficits at 6 months (P < .001). Baseline PTSD symptoms were associated with 12-month PTSD symptoms (P < .04).
EF deficits at 6 months were also associated with 12-month PTSD symptoms (P = .02).
Importantly, no associations were observed between baseline or 6-month PTSD symptoms and EF deficits at 12 months. However, EF deficits at 6 months drove the relationship between PTSD symptoms at baseline and at 1 year (indirect effect = .061).
“What this suggests is that executive-function deficits are a mechanism that maintains patients’ symptoms over the course of 1 year,” Dr. Bardeen said.
“And you don’t see the reverse,” he added. “You don’t see that PTSD symptoms at [6 months] mediate the relationship between [baseline] and 6 month executive-function deficits.”
Surprising finding
The findings suggest deficits in executive functioning have a stronger role in maintaining PTSD symptoms than these symptoms have in maintaining EF deficits, Dr. Bardeen told this news organization.
“I had originally hypothesized a bidirectional relationship in which PTSD symptoms influenced future executive-function deficits and executive-function deficits influenced future PTSD symptoms,” he said.
“So, it was a surprise that, when accounting for both variables in the same model, executive-function deficits predicted future PTSD symptoms, but PTSD symptoms did not significantly predict future EF deficits,” he added.
Dr. Bardeen noted this suggests that EF deficits “may be a particularly important maintenance factor.”
In addition, he recommended the use of neuropsychological assessments prior to treatment to identify individuals with EF deficits and distinguish those deficits from PTSD symptoms.
“There is certainly overlap between executive-function deficits and PTSD symptoms,” Dr. Bardeen said. “For example, several of the symptoms of PTSD, such as concentration difficulties, may be indicators of executive-function deficits.”
He noted assessments such as the Delis Kaplan Executive Function System, and Clinician Administered PTSD Scale for DSM-5, when used as part of a larger assessment battery, can help differentiate between the EF deficits and PTSD.
“This would take several hours to administer, but in cases in which serious cognitive impairment is suspected, a comprehensive assessment is the way to go,” Dr. Bardeen said.
The standard approaches of prolonged exposure therapy and cognitive processing therapy can be effective in patients without EF deficits, while some modifications may benefit those with these deficits, he added.
“For example, it’s important to provide a more directive and structured environment in which the practitioner repeats key points frequently, uses concrete language, simplifies worksheets, and provides written summaries and reminder cards,” he said.
Further findings
In additional research presented at the meeting, Elsa Mattson, a PhD student from Case Western Reserve University, Cleveland, and colleagues reported findings further distinguishing the role of EF in PTSD.
In that study of 149 patients with chronic PTSD, those with low performing working memory, but not high working memory, had higher pre- as well as posttreatment PTSD symptom severity and depressive symptoms.
“Clinicians should consider that impairments in executive function may play a role in reduced treatment response, potentially impairing a client’s ability to learn new information in treatment,” the investigators wrote.
“Understanding how executive function processes change over the course of treatment, particularly in relation to processing the trauma memories, is an important next step,” they added.
The first study was supported by a grant from the National Institute of Mental Health. The investigators have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DENVER –
“To our knowledge, this study is the first to show that executive-function deficits maintain PTSD symptoms following trauma exposure,” investigators noted in research presented at the Anxiety and Depression Association of America (ADAA) Anxiety & Depression conference.
The results are important in “developing precision medicine–based approaches for alleviating [posttraumatic stress] symptoms, and improving well-established PTSD treatments for those with relative deficits in executive function,” study investigator Joseph R. Bardeen, PhD, associate professor at Auburn (Ala.) University, told meeting attendees.
The findings were published in the Journal of Anxiety Disorders.
Cognitive impairment
In earlier research, deficits in EF were associated with an increased vulnerability for PTSD symptoms. However, less is known about the role of these deficits, which can impair higher-level cognitive ability, in sustaining PTSD symptoms.
To investigate, the authors conducted a longitudinal study that included 98 participants aged 18-65 years who had been identified via phone screening as experiencing clinically significant PTSD symptoms.
Participants completed self-report measures for PTSD symptoms, as well as measures for EF deficits at baseline and 6-month (n = 92) and 12-month (n = 91) follow-up sessions.
A path analysis showed a significant relationship between baseline PTSD symptoms and EF deficits at 6 months (P < .001). Baseline PTSD symptoms were associated with 12-month PTSD symptoms (P < .04).
EF deficits at 6 months were also associated with 12-month PTSD symptoms (P = .02).
Importantly, no associations were observed between baseline or 6-month PTSD symptoms and EF deficits at 12 months. However, EF deficits at 6 months drove the relationship between PTSD symptoms at baseline and at 1 year (indirect effect = .061).
“What this suggests is that executive-function deficits are a mechanism that maintains patients’ symptoms over the course of 1 year,” Dr. Bardeen said.
“And you don’t see the reverse,” he added. “You don’t see that PTSD symptoms at [6 months] mediate the relationship between [baseline] and 6 month executive-function deficits.”
Surprising finding
The findings suggest deficits in executive functioning have a stronger role in maintaining PTSD symptoms than these symptoms have in maintaining EF deficits, Dr. Bardeen told this news organization.
“I had originally hypothesized a bidirectional relationship in which PTSD symptoms influenced future executive-function deficits and executive-function deficits influenced future PTSD symptoms,” he said.
“So, it was a surprise that, when accounting for both variables in the same model, executive-function deficits predicted future PTSD symptoms, but PTSD symptoms did not significantly predict future EF deficits,” he added.
Dr. Bardeen noted this suggests that EF deficits “may be a particularly important maintenance factor.”
In addition, he recommended the use of neuropsychological assessments prior to treatment to identify individuals with EF deficits and distinguish those deficits from PTSD symptoms.
“There is certainly overlap between executive-function deficits and PTSD symptoms,” Dr. Bardeen said. “For example, several of the symptoms of PTSD, such as concentration difficulties, may be indicators of executive-function deficits.”
He noted assessments such as the Delis Kaplan Executive Function System, and Clinician Administered PTSD Scale for DSM-5, when used as part of a larger assessment battery, can help differentiate between the EF deficits and PTSD.
“This would take several hours to administer, but in cases in which serious cognitive impairment is suspected, a comprehensive assessment is the way to go,” Dr. Bardeen said.
The standard approaches of prolonged exposure therapy and cognitive processing therapy can be effective in patients without EF deficits, while some modifications may benefit those with these deficits, he added.
“For example, it’s important to provide a more directive and structured environment in which the practitioner repeats key points frequently, uses concrete language, simplifies worksheets, and provides written summaries and reminder cards,” he said.
Further findings
In additional research presented at the meeting, Elsa Mattson, a PhD student from Case Western Reserve University, Cleveland, and colleagues reported findings further distinguishing the role of EF in PTSD.
In that study of 149 patients with chronic PTSD, those with low performing working memory, but not high working memory, had higher pre- as well as posttreatment PTSD symptom severity and depressive symptoms.
“Clinicians should consider that impairments in executive function may play a role in reduced treatment response, potentially impairing a client’s ability to learn new information in treatment,” the investigators wrote.
“Understanding how executive function processes change over the course of treatment, particularly in relation to processing the trauma memories, is an important next step,” they added.
The first study was supported by a grant from the National Institute of Mental Health. The investigators have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
REPORTING FROM ADAA 2022