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The effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse/recurrence: results of a randomised controlled trial (the PREVENT study).

Willem Kuyken, Rachel Hayes, Barbara Barrett, Richard Byng, Tim Dalgleish, David Kessler, Glyn Lewis, Edward R. Watkins, Nicola Morant, Rod S. Taylor, Sarah Byford

Health technology assessment September 2015 DOI: 10.3310/hta19730 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Qualitative Peer reviewed
Sample size 424
Population Adult primary care patients in the UK with a diagnosis of recurrent depression who were taking maintenance antidepressant medication
Intervention maintenance antidepressant medication (m-ADM)
Duration 24-month follow-up
Topics Meditation
Key findings MBCT with support to taper or discontinue antidepressants was not superior to maintenance antidepressants for preventing depressive relapse/recurrence over 24 months (HR 0.89, 95% CI 0.67 to 1.18), and cost-effectiveness analyses did not support it as more cost-effective. Both treatments appeared to confer protection against relapse. A planned subgroup analysis suggested MBCT-TS delayed relapse among participants reporting a more abusive childhood (HR 1.89, 95% CI 1.06 to 3.38).

Abstract

Individuals with a history of recurrent depression have a high risk of repeated depressive relapse/recurrence. Maintenance antidepressant medication (m-ADM) for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to m-ADM. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce the risk of relapse/recurrence compared with usual care but has not yet been compared with m-ADM in a definitive trial. To establish whether MBCT with support to taper and/or discontinue antidepressant medication (MBCT-TS) is superior to and more cost-effective than an approach of m-ADM in a primary care setting for patients with a history of recurrent depression followed up over a 2-year period in terms of preventing depressive relapse/recurrence. Secondary aims examined MBCT's acceptability and mechanism of action. Single-blind, parallel, individual randomised controlled trial. UK general practices. Adult patients with a diagnosis of recurrent depression and who were taking m-ADM. Participants were randomised to MBCT-TS or m-ADM with stratification by centre and symptomatic status. Outcome data were collected blind to treatment allocation and the primary analysis was based on the principle of intention to treat. Process studies using quantitative and qualitative methods examined MBCT's acceptability and mechanism of action. The primary outcome measure was time to relapse/recurrence of depression. At each follow-up the following secondary outcomes were recorded: number of depression-free days, residual depressive symptoms, quality of life, health-related quality of life and psychiatric and medical comorbidities. In total, 212 patients were randomised to MBCT-TS and 212 to m-ADM. The primary analysis did not find any evidence that MBCT-TS was superior to m-ADM in terms of the primary outcome of time to depressive relapse/recurrence over 24 months [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.67 to 1.18] or for any of the secondary outcomes. Cost-effectiveness analysis did not support the hypothesis that MBCT-TS is more cost-effective than m-ADM in terms of either relapse/recurrence or quality-adjusted life-years. In planned subgroup analyses, a significant interaction was found between treatment group and reported childhood abuse (HR 1.89, 95% CI 1.06 to 3.38), with delayed time to relapse/recurrence for MBCT-TS participants with a more abusive childhood compared with those with a less abusive history. Although changes in mindfulness were specific to MBCT (and not m-ADM), they did not predict outcome in terms of relapse/recurrence at 24 months. In terms of acceptability, the qualitative analyses suggest that many people have views about (dis)/continuing their ADM, which can serve as a facilitator or a barrier to taking part in a trial that requires either continuation for 2 years or discontinuation. There is no support for the hypothesis that MBCT-TS is superior to m-ADM in preventing depressive relapse/recurrence among individuals at risk for depressive relapse/recurrence. Both treatments appear to confer protection against relapse/recurrence. There is an indication that MBCT may be most indicated for individuals at greatest risk of relapse/recurrence. It is important to characterise those most at risk and carefully establish if and why MBCT may be most indicated for this group. Current Controlled Trials ISRCTN26666654. This project was funded by the NIHR Health Technology Assessment programme and the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care South West Peninsula and will be published in full in Health Technology Assessment; Vol. 19, No. 73. See the NIHR Journals Library website for further project information.

Comparable studies

Other randomized controlled trials on meditation, most cited first.

Study Year Design Participants
Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment 2003 Randomized controlled trial n = 41
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults 2008 Randomized controlled trial n = 139
Short-term meditation training improves attention and self-regulation Undergraduate Chinese students 2007 Randomized controlled trial n = 40
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

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