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BackgroundDepression is a common condition that typically has a relapsing course. Effective interventions targeting relapse have the potential to dramatically reduce the point prevalence of the condition. Mindfulness-based cognitive therapy (MBCT) is a group-based intervention that has shown efficacy in reducing depressive relapse. While trials of MBCT to date have met the core requirements of phase 1 translational research, there is a need now to move to phase 2 translational research - the application of MBCT within real-world settings with a view to informing policy and clinical practice. The aim of this trial is to examine the clinical impact and health economics of MBCT under real-world conditions and where efforts have been made to assess for and prevent resentful demoralization among the control group. Secondary aims of the project involve extending the phase 1 agenda to an examination of the effects of co-morbidity and mechanisms of action.
Methods/Design
This study is designed as a prospective, multi-site, single-blind, randomised controlled trial using a group comparison design between involving the intervention, MBCT, and a self-monitoring comparison condition, Depression Relapse Active Monitoring (DRAM). Follow-up is over 2 years. The design of the study indicates recruitment from primary and secondary care of 204 participants who have a history of 3 or more episodes of Major Depression but who are currently well. Measures assessing depressive relapse/recurrence, time to first clinical intervention, treatment expectancy and a range of secondary outcomes and process variables are included. A health economics evaluation will be undertaken to assess the incremental cost of MBCT.
Discussion
The results of this trial, including an examination of clinical, functional and health economic outcomes, will be used to assess the role that this treatment approach may have in recommendations for treatment of depression in Australia and elsewhere. If the findings are positive, we expect that this research will consolidate the evidence base to guide the decision to fund MBCT and to seek to promote its availability to those who have experienced at least 3 episodes of depression.
OBJECTIVES:Major depressive disorder is a significant mental illness that is highly likely to recur, particularly after three or more previous episodes. Increased mindfulness and decreased rumination have both been associated with decreased depressive relapse. The aim of this study was to investigate whether rumination mediates the relationship between mindfulness and depressive relapse.
DESIGN:
This prospective design involved a secondary data analysis for identifying causal mechanisms using mediation analysis.
METHODS:
This study was embedded in a pragmatic randomized controlled trial of mindfulness-based cognitive therapy (MBCT) in which 203 participants (165 females, 38 males; mean age: 48 years), with a history of at least three previous episodes of depression, completed measures of mindfulness, rumination, and depressive relapse over a 2-year follow-up period. Specific components of mindfulness and rumination, being nonjudging and brooding, respectively, were also explored.
RESULTS:
While higher mindfulness scores predicted reductions in rumination and depressive relapse, the relationship between mindfulness and relapse was not found to be mediated by rumination, although there appeared to be a trend.
CONCLUSIONS:
Our results strengthen the argument that mindfulness may be important in preventing relapse but that rumination is not a significant mediator of its effects. The study was adequately powered to detect medium mediation effects, but it is possible that smaller effects were present but not detected.
PRACTITIONER POINTS:
Mindfulness may be one of several components of MBCT contributing to prevention of depressive relapse. Although the original rationale for MBCT rested largely on a model of relapse causally linked to rumination, our findings suggest that the mechanism by which mindfulness impacts relapse is more complex than a simple effect on rumination.
Kuyken W, Warren FC, Taylor RS, et al. Efficacy of mindfulness-based cognitive therapy in prevention of depressive relapse: an individual patient data meta-analysis from randomized trials.Several meta-analyses of about 20 year’s work on randomised controlled trials (RCTs) with mindfulness-based cognitive therapy for depression (MBCT)1 have concluded that MBCT is efficacious in reducing relapse/recurrence where people have had at least three major depressive episodes (MDEs).
Objective:While mindfulness-based cognitive therapy (MBCT) has demonstrated efficacy in reducing depressive relapse/recurrence over 12–18 months, questions remain around effectiveness, longer-term outcomes, and suitability in combination with medication. The aim of this study was to investigate within a pragmatic study design the effectiveness of MBCT on depressive relapse/recurrence over 2 years of follow-up.
Method:
This was a prospective, multi-site, single-blind trial based in Melbourne and the regional city of Geelong, Australia. Non-depressed adults with a history of three or more episodes of depression were randomised to MBCT + depression relapse active monitoring (DRAM) (n=101) or control (DRAM alone) (n=102). Randomisation was stratified by medication (prescribed antidepressants and/or mood stabilisers: yes/no), site of usual care (primary or specialist), diagnosis (bipolar disorder: yes/no) and sex. Relapse/recurrence of major depression was assessed over 2 years using the Composite International Diagnostic Interview 2.1.
Results:
The average number of days with major depression was 65 for MBCT participants and 112 for controls, significant with repeated-measures ANOVA (F(1, 164)=4.56, p=0.03). Proportionally fewer MBCT participants relapsed in both year 1 and year 2 compared to controls (odds ratio 0.45, p<0.05). Kaplan-Meier survival analysis for time to first depressive episode was non-significant, although trends favouring the MBCT group were suggested. Subgroup analyses supported the effectiveness of MBCT for people receiving usual care in a specialist setting and for people taking antidepressant/mood stabiliser medication.
Conclusions:
This work in a pragmatic design with an active control condition supports the effectiveness of MBCT in something closer to implementation in routine practice than has been studied hitherto. As expected in this translational research design, observed effects were less strong than in some previous efficacy studies but appreciable and significant differences in outcome were detected. MBCT is most clearly demonstrated as effective for people receiving specialist care and seems to work well combined with antidepressants.
Objective:While mindfulness-based cognitive therapy (MBCT) has demonstrated efficacy in reducing depressive relapse/recurrence over 12–18 months, questions remain around effectiveness, longer-term outcomes, and suitability in combination with medication. The aim of this study was to investigate within a pragmatic study design the effectiveness of MBCT on depressive relapse/recurrence over 2 years of follow-up.
Method:
This was a prospective, multi-site, single-blind trial based in Melbourne and the regional city of Geelong, Australia. Non-depressed adults with a history of three or more episodes of depression were randomised to MBCT + depression relapse active monitoring (DRAM) (n=101) or control (DRAM alone) (n=102). Randomisation was stratified by medication (prescribed antidepressants and/or mood stabilisers: yes/no), site of usual care (primary or specialist), diagnosis (bipolar disorder: yes/no) and sex. Relapse/recurrence of major depression was assessed over 2 years using the Composite International Diagnostic Interview 2.1.
Results:
The average number of days with major depression was 65 for MBCT participants and 112 for controls, significant with repeated-measures ANOVA (F(1, 164)=4.56, p=0.03). Proportionally fewer MBCT participants relapsed in both year 1 and year 2 compared to controls (odds ratio 0.45, p<0.05). Kaplan-Meier survival analysis for time to first depressive episode was non-significant, although trends favouring the MBCT group were suggested. Subgroup analyses supported the effectiveness of MBCT for people receiving usual care in a specialist setting and for people taking antidepressant/mood stabiliser medication.
Conclusions:
This work in a pragmatic design with an active control condition supports the effectiveness of MBCT in something closer to implementation in routine practice than has been studied hitherto. As expected in this translational research design, observed effects were less strong than in some previous efficacy studies but appreciable and significant differences in outcome were detected. MBCT is most clearly demonstrated as effective for people receiving specialist care and seems to work well combined with antidepressants.
Objective:While mindfulness-based cognitive therapy is effective in reducing depressive relapse/recurrence, relatively little is known about its health economic properties. We describe the health economic properties of mindfulness-based cognitive therapy in relation to its impact on depressive relapse/recurrence over 2 years of follow-up.
Method:
Non-depressed adults with a history of three or more major depressive episodes were randomised to mindfulness-based cognitive therapy + depressive relapse active monitoring (n = 101) or control (depressive relapse active monitoring alone) (n = 102) and followed up for 2 years. Structured self-report instruments for service use and absenteeism provided cost data items for health economic analyses. Treatment utility, expressed as disability-adjusted life years, was calculated by adjusting the number of days an individual was depressed by the relevant International Classification of Diseases 12-month severity of depression disability weight from the Global Burden of Disease 2010. Intention-to-treat analysis assessed the incremental cost–utility ratios of the interventions across mental health care, all of health-care and whole-of-society perspectives. Per protocol and site of usual care subgroup analyses were also conducted. Probabilistic uncertainty analysis was completed using cost–utility acceptability curves.
Results:
Mindfulness-based cognitive therapy participants had significantly less major depressive episode days compared to controls, as supported by the differential distributions of major depressive episode days (modelled as Poisson, p < 0.001). Average major depressive episode days were consistently less in the mindfulness-based cognitive therapy group compared to controls, e.g., 31 and 55 days, respectively. From a whole-of-society perspective, analyses of patients receiving usual care from all sectors of the health-care system demonstrated dominance (reduced costs, demonstrable health gains). From a mental health-care perspective, the incremental gain per disability-adjusted life year for mindfulness-based cognitive therapy was AUD83,744 net benefit, with an overall annual cost saving of AUD143,511 for people in specialist care.
Conclusion:
Mindfulness-based cognitive therapy demonstrated very good health economic properties lending weight to the consideration of mindfulness-based cognitive therapy provision as a good buy within health-care delivery.