Open Access Highly Accessed Study protocol

Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial

Willem Kuyken1*, Sarah Byford2, Richard Byng3, Tim Dalgleish4, Glyn Lewis5, Rod Taylor3, Edward R Watkins1, Rachel Hayes1, Paul Lanham6, David Kessler5, Nicola Morant7 and Alison Evans1

Author Affiliations

1 Mood Disorders Centre, School of Psychology, University of Exeter, EX4 4QG, UK

2 King's College London, Centre for the Economics of Mental Health, Box PO24, Institute of Psychiatry, De Crespigny Park, London, UK

3 Peninsula College of Medicine and Dentistry, University of Plymouth, Plymouth, UK

4 Medical Research Council Cognition and Brain Sciences Unit, Chaucer Road, Cambridge, UK

5 Academic Unit of Psychiatry, University of Bristol, Cotham Hill, UK

6 c/o Depression Alliance, 20 Great Dover Street, London, UK

7 Dept. of Social and Developmental Psychology, University of Cambridge, Cambridge, UK

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Trials 2010, 11:99  doi:10.1186/1745-6215-11-99

Published: 20 October 2010

Abstract

Background

Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM) can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depressive relapse/recurrence. A recently developed treatment, Mindfulness-based Cognitive Therapy (MBCT, see http://www.mbct.co.uk webcite) shows potential as a brief group programme for people with recurring depression. In two studies it has been shown to halve the rates of depression recurring compared to usual care.

This trial asks the policy research question, is MBCT superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and, secondary outcomes of (a) depression free days, (b) residual depressive symptoms, (c) antidepressant (ADM) usage, (d) psychiatric and medical co-morbidity, (e) quality of life, and (f) cost effectiveness? An explanatory research question asks is an increase in mindfulness skills the key mechanism of change?

Methods/Design

The design is a single blind, parallel RCT examining MBCT vs. m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT plus ADM-tapering with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care. Depressive relapse/recurrence over two years is the primary outcome variable. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre/post-treatment and a qualitative study of service users' views and experiences.

Discussion

If the results of our exploratory trial are extended to this definitive trial, MBCT will be established as an alternative approach to maintenance anti-depressants for people with a history of recurrent depression. The process studies will provide evidence about the effective components which can be used to improve MBCT and inform theory as well as other therapeutic approaches.

Trial registration number

ISRCTN26666654