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Much of the ongoing morbidity in patients suffering majordepressive disorders is related to current treatments failing to produce complete remission. Many patients can be considered to
have treatment-resistant depression (TRD), with failure to fully
remit with adequate doses and durations of 2 or more antidepressant trials [1, 2] . TRD is associated with greater disability, mortality, morbidity, somatic symptoms, risk of relapse and societal cost
[3, 4] . We report on a pilot study of mindfulness-based cognitive
therapy (MBCT) for TRD.
Much of the ongoing morbidity in patients suffering majordepressive disorders is related to current treatments failing to produce complete remission. Many patients can be considered to
have treatment-resistant depression (TRD), with failure to fully
remit with adequate doses and durations of 2 or more antidepressant trials [1, 2] . TRD is associated with greater disability, mortality, morbidity, somatic symptoms, risk of relapse and societal cost
[3, 4] . We report on a pilot study of mindfulness-based cognitive
therapy (MBCT) for TRD.
BackgroundMajor depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. Up to 40% of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have “treatment-resistant depression” (TRD). There is an urgent need for cost-effective, non-pharmacologic, evidence-based treatments for TRD. Mindfulness-Based Cognitive Therapy (MBCT) is an effective treatment for relapse prevention and residual depression in major depression, but has not been previously studied in patients with TRD in a large randomized trial.
Methods/Design
The purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy. MBCT was compared to an active control condition, the Health-Enhancement Program (HEP), which incorporates physical activity, functional movement, music therapy and nutritional advice. HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects. Originally investigated in a non-clinical sample to promote stress reduction, HEP was adapted for a depressed population for this study. Individuals age 18 and older with moderate to severe TRD, who failed to respond to at least two trials of antidepressants in the current episode, were recruited to participate. All participants were taking antidepressants (Treatment as usual; TAU) at the time of enrollment. After signing an informed consent, participants were randomly assigned to either MBCT or HEP condition. Participants were followed for 1 year and assessed at weeks 1–7, 8, 24, 36, and 52. Change in depression severity, rate of treatment response and remission after 8 weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating (HAM-D) 17-item scale. The participant-rated Quick Inventory of Depression Symptomology (QIDS-SR) 16-item scale was the secondary outcome measure of depression severity, response, and remission.
Discussion
Treatment-resistant depression entails significant morbidity and has few effective treatments. We studied the effect of augmenting antidepressant medication with MBCT, compared with a HEP control, for patients with TRD. Analyses will focus on clinician and patient assessment of depression, participants’ clinical global impression change, employment and social functioning scores and quality of life and satisfaction ratings.
BackgroundMajor depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. Up to 40% of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have “treatment-resistant depression” (TRD). There is an urgent need for cost-effective, non-pharmacologic, evidence-based treatments for TRD. Mindfulness-Based Cognitive Therapy (MBCT) is an effective treatment for relapse prevention and residual depression in major depression, but has not been previously studied in patients with TRD in a large randomized trial.
Methods/Design
The purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy. MBCT was compared to an active control condition, the Health-Enhancement Program (HEP), which incorporates physical activity, functional movement, music therapy and nutritional advice. HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects. Originally investigated in a non-clinical sample to promote stress reduction, HEP was adapted for a depressed population for this study. Individuals age 18 and older with moderate to severe TRD, who failed to respond to at least two trials of antidepressants in the current episode, were recruited to participate. All participants were taking antidepressants (Treatment as usual; TAU) at the time of enrollment. After signing an informed consent, participants were randomly assigned to either MBCT or HEP condition. Participants were followed for 1 year and assessed at weeks 1–7, 8, 24, 36, and 52. Change in depression severity, rate of treatment response and remission after 8 weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating (HAM-D) 17-item scale. The participant-rated Quick Inventory of Depression Symptomology (QIDS-SR) 16-item scale was the secondary outcome measure of depression severity, response, and remission.
Discussion
Treatment-resistant depression entails significant morbidity and has few effective treatments. We studied the effect of augmenting antidepressant medication with MBCT, compared with a HEP control, for patients with TRD. Analyses will focus on clinician and patient assessment of depression, participants’ clinical global impression change, employment and social functioning scores and quality of life and satisfaction ratings.
BackgroundMajor depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. Up to 40% of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have “treatment-resistant depression” (TRD). There is an urgent need for cost-effective, non-pharmacologic, evidence-based treatments for TRD. Mindfulness-Based Cognitive Therapy (MBCT) is an effective treatment for relapse prevention and residual depression in major depression, but has not been previously studied in patients with TRD in a large randomized trial.
Methods/Design
The purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy. MBCT was compared to an active control condition, the Health-Enhancement Program (HEP), which incorporates physical activity, functional movement, music therapy and nutritional advice. HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects. Originally investigated in a non-clinical sample to promote stress reduction, HEP was adapted for a depressed population for this study. Individuals age 18 and older with moderate to severe TRD, who failed to respond to at least two trials of antidepressants in the current episode, were recruited to participate. All participants were taking antidepressants (Treatment as usual; TAU) at the time of enrollment. After signing an informed consent, participants were randomly assigned to either MBCT or HEP condition. Participants were followed for 1 year and assessed at weeks 1–7, 8, 24, 36, and 52. Change in depression severity, rate of treatment response and remission after 8 weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating (HAM-D) 17-item scale. The participant-rated Quick Inventory of Depression Symptomology (QIDS-SR) 16-item scale was the secondary outcome measure of depression severity, response, and remission.
Discussion
Treatment-resistant depression entails significant morbidity and has few effective treatments. We studied the effect of augmenting antidepressant medication with MBCT, compared with a HEP control, for patients with TRD. Analyses will focus on clinician and patient assessment of depression, participants’ clinical global impression change, employment and social functioning scores and quality of life and satisfaction ratings.
Major depressive disorder is often chronic and characterized by relapse and recurrence despite successful treatments to induce remission. Mindfulness-based cognitive therapy (MBCT) was developed as a means of preventing relapse for individuals in remission using cognitive interventions. In addition, MBCT has preliminarily been found to be useful in treating active depression. This current investigation is unique in evaluating the long-term outcome of individuals with active depression who achieved remission with MBCT. Eighteen participants who achieved remission after an 8-week MBCT group were seen for evaluation at a mean follow-up interval of 48.7 months (SD = 10.2) after completing treatment. The current study shows that in these participants, the gains achieved after the initial treatment including remission of depression, decreased rumination, decreased anxiety, and increased mindfulness continued for up to 58.9 months of follow-up. The data suggest that all levels of depression from less recurrent and mild to more recurrent and severe were responsive to MBCT. The average number of minutes per week of continued practice in our cohort was 210, but the number of minutes of practice did not correlate with depression outcomes. MBCT's effects may be more related to regularity of practice than specific quantity. This study provides a preliminary exploration of MBCT's long-term effects, which can aid in future research with a typically chronic illness.
Major depressive disorder is often chronic and characterized by relapse and recurrence despite successful treatments to induce remission. Mindfulness-based cognitive therapy (MBCT) was developed as a means of preventing relapse for individuals in remission using cognitive interventions. In addition, MBCT has preliminarily been found to be useful in treating active depression. This current investigation is unique in evaluating the long-term outcome of individuals with active depression who achieved remission with MBCT. Eighteen participants who achieved remission after an 8-week MBCT group were seen for evaluation at a mean follow-up interval of 48.7 months (SD = 10.2) after completing treatment. The current study shows that in these participants, the gains achieved after the initial treatment including remission of depression, decreased rumination, decreased anxiety, and increased mindfulness continued for up to 58.9 months of follow-up. The data suggest that all levels of depression from less recurrent and mild to more recurrent and severe were responsive to MBCT. The average number of minutes per week of continued practice in our cohort was 210, but the number of minutes of practice did not correlate with depression outcomes. MBCT's effects may be more related to regularity of practice than specific quantity. This study provides a preliminary exploration of MBCT's long-term effects, which can aid in future research with a typically chronic illness.
Major depressive disorder is often chronic and characterized by relapse and recurrence despite successful treatments to induce remission. Mindfulness-based cognitive therapy (MBCT) was developed as a means of preventing relapse for individuals in remission using cognitive interventions. In addition, MBCT has preliminarily been found to be useful in treating active depression. This current investigation is unique in evaluating the long-term outcome of individuals with active depression who achieved remission with MBCT. Eighteen participants who achieved remission after an 8-week MBCT group were seen for evaluation at a mean follow-up interval of 48.7 months (SD = 10.2) after completing treatment. The current study shows that in these participants, the gains achieved after the initial treatment including remission of depression, decreased rumination, decreased anxiety, and increased mindfulness continued for up to 58.9 months of follow-up. The data suggest that all levels of depression from less recurrent and mild to more recurrent and severe were responsive to MBCT. The average number of minutes per week of continued practice in our cohort was 210, but the number of minutes of practice did not correlate with depression outcomes. MBCT's effects may be more related to regularity of practice than specific quantity. This study provides a preliminary exploration of MBCT's long-term effects, which can aid in future research with a typically chronic illness.
Major depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. The primary aim of this pilot study was to investigate the efficacy of mindfulness-based cognitive therapy (MBCT) monotherapy, compared to sertraline monotherapy, for patients with acute MDD. This open-label, nonrandomized controlled trial examined a MBCT cohort (N = 23) recruited to match the gender, age, and depression severity of a depressed control group (N = 20) that completed 8 weeks of monotherapy with the antidepressant sertraline. The 17-item clinician-rated Hamilton Depression Severity Rating Scale (HAMD-17) was the primary outcome measure of depression to assess overall change after 8 weeks and rates of response and remission. The 16-item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) was the secondary outcome measure to further assess depression severity. Both cohorts were demographically similar and showed significant improvement in depression ratings. No difference was found in the degree of change in HAMD-17 scores (t(34) = 1.42, p = 0.165) between groups. Secondary analysis showed statistically significant differences in mean scores of the QIDS-SR16 (t(32) = 4.39, p < 0.0001), with the MBCT group showing greater mean improvement. This study was limited by the small sample size and non-randomized, non-blinded design. Preliminary findings suggest that an 8-week course of MBCT monotherapy may be effective in treating MDD and is a viable alternative to antidepressant medication. Greater changes in the self-rated QIDS-SR16 for the MBCT cohort raise the possibility that patients derive additional subjective benefit from enhanced self-efficacy skills.
Major depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. The primary aim of this pilot study was to investigate the efficacy of mindfulness-based cognitive therapy (MBCT) monotherapy, compared to sertraline monotherapy, for patients with acute MDD. This open-label, nonrandomized controlled trial examined a MBCT cohort (N = 23) recruited to match the gender, age, and depression severity of a depressed control group (N = 20) that completed 8 weeks of monotherapy with the antidepressant sertraline. The 17-item clinician-rated Hamilton Depression Severity Rating Scale (HAMD-17) was the primary outcome measure of depression to assess overall change after 8 weeks and rates of response and remission. The 16-item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) was the secondary outcome measure to further assess depression severity. Both cohorts were demographically similar and showed significant improvement in depression ratings. No difference was found in the degree of change in HAMD-17 scores (t(34) = 1.42, p = 0.165) between groups. Secondary analysis showed statistically significant differences in mean scores of the QIDS-SR16 (t(32) = 4.39, p < 0.0001), with the MBCT group showing greater mean improvement. This study was limited by the small sample size and non-randomized, non-blinded design. Preliminary findings suggest that an 8-week course of MBCT monotherapy may be effective in treating MDD and is a viable alternative to antidepressant medication. Greater changes in the self-rated QIDS-SR16 for the MBCT cohort raise the possibility that patients derive additional subjective benefit from enhanced self-efficacy skills.
Major depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. The primary aim of this pilot study was to investigate the efficacy of mindfulness-based cognitive therapy (MBCT) monotherapy, compared to sertraline monotherapy, for patients with acute MDD. This open-label, nonrandomized controlled trial examined a MBCT cohort (N = 23) recruited to match the gender, age, and depression severity of a depressed control group (N = 20) that completed 8 weeks of monotherapy with the antidepressant sertraline. The 17-item clinician-rated Hamilton Depression Severity Rating Scale (HAMD-17) was the primary outcome measure of depression to assess overall change after 8 weeks and rates of response and remission. The 16-item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) was the secondary outcome measure to further assess depression severity. Both cohorts were demographically similar and showed significant improvement in depression ratings. No difference was found in the degree of change in HAMD-17 scores (t(34) = 1.42, p = 0.165) between groups. Secondary analysis showed statistically significant differences in mean scores of the QIDS-SR16 (t(32) = 4.39, p < 0.0001), with the MBCT group showing greater mean improvement. This study was limited by the small sample size and non-randomized, non-blinded design. Preliminary findings suggest that an 8-week course of MBCT monotherapy may be effective in treating MDD and is a viable alternative to antidepressant medication. Greater changes in the self-rated QIDS-SR16 for the MBCT cohort raise the possibility that patients derive additional subjective benefit from enhanced self-efficacy skills.
BACKGROUND:Due to the clinical challenges of treatment-resistant depression (TRD), we evaluated the efficacy of mindfulness-based cognitive therapy (MBCT) relative to a structurally equivalent active comparison condition as adjuncts to treatment-as-usual (TAU) pharmacotherapy in TRD.
METHODS:
This single-site, randomized controlled trial compared 8-week courses of MBCT and the Health Enhancement Program (HEP), comprising physical fitness, music therapy and nutritional education, as adjuncts to TAU pharmacotherapy for outpatient adults with TRD. The primary outcome was change in depression severity, measured by percent reduction in the total score on the 17-item Hamilton Depression Rating Scale (HAM-D17), with secondary depression indicators of treatment response and remission.
RESULTS:
We enrolled 173 adults; mean length of a current depressive episode was 6.8 years (SD = 8.9). At the end of 8 weeks of treatment, a multivariate analysis showed that relative to the HEP condition, the MBCT condition was associated with a significantly greater mean percent reduction in the HAM-D17 (36.6 vs. 25.3%; p = 0.01) and a significantly higher rate of treatment responders (30.3 vs. 15.3%; p = 0.03). Although numerically superior for MBCT than for HEP, the rates of remission did not significantly differ between treatments (22.4 vs. 13.9%; p = 0.15). In these models, state anxiety, perceived stress and the presence of personality disorder had adverse effects on outcomes.
CONCLUSIONS:
MBCT significantly decreased depression severity and improved treatment response rates at 8 weeks but not remission rates. MBCT appears to be a viable adjunct in the management of TRD.
BACKGROUND:Due to the clinical challenges of treatment-resistant depression (TRD), we evaluated the efficacy of mindfulness-based cognitive therapy (MBCT) relative to a structurally equivalent active comparison condition as adjuncts to treatment-as-usual (TAU) pharmacotherapy in TRD.
METHODS:
This single-site, randomized controlled trial compared 8-week courses of MBCT and the Health Enhancement Program (HEP), comprising physical fitness, music therapy and nutritional education, as adjuncts to TAU pharmacotherapy for outpatient adults with TRD. The primary outcome was change in depression severity, measured by percent reduction in the total score on the 17-item Hamilton Depression Rating Scale (HAM-D17), with secondary depression indicators of treatment response and remission.
RESULTS:
We enrolled 173 adults; mean length of a current depressive episode was 6.8 years (SD = 8.9). At the end of 8 weeks of treatment, a multivariate analysis showed that relative to the HEP condition, the MBCT condition was associated with a significantly greater mean percent reduction in the HAM-D17 (36.6 vs. 25.3%; p = 0.01) and a significantly higher rate of treatment responders (30.3 vs. 15.3%; p = 0.03). Although numerically superior for MBCT than for HEP, the rates of remission did not significantly differ between treatments (22.4 vs. 13.9%; p = 0.15). In these models, state anxiety, perceived stress and the presence of personality disorder had adverse effects on outcomes.
CONCLUSIONS:
MBCT significantly decreased depression severity and improved treatment response rates at 8 weeks but not remission rates. MBCT appears to be a viable adjunct in the management of TRD.