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Update to the study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment 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, Perry Road, University of Exeter, Exeter EX4 4QG, UK

2 King’s College London, Centre for the Economics of Mental and Physical Health, Box PO24, Institute of Psychiatry, De Crespigny Park, London SE5 8AF, UK

3 Primary Care Group, Peninsula College of Medicine and Dentistry, University of Plymouth, N32, Tamar Science Park, Drake Circus, Plymouth PL4 8AA, Devon

4 Medical Research Council Cognition and Brain Sciences Unit, Chaucer Road, Cambridge CB2 7EF, UK

5 School of Social and Community Medicine, Oakfield House, Oakfield Grove, University of Bristol, Bristol BS8 2BN, UK

6 10 Alexander Close, Clifton SG17 5RB, Bedfordshire

7 Department of Psychology, University of Cambridge, Downing Street, Cambridge CB2 3 EB, UK

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Trials 2014, 15:217  doi:10.1186/1745-6215-15-217

Published: 10 June 2014

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. A recently developed treatment, mindfulness-based cognitive therapy (MBCT), shows potential as a brief group program for people with recurring depression.

This trial asks the policy research question; is MBCT with support to taper/discontinue antidepressant medication (MBCT-TS) 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 medication (ADM) usage, (d) psychiatric and medical co-morbidity, (e) quality of life, and (f) cost effectiveness? An explanatory research question also asks whether an increase in mindfulness skills is the key mechanism of change.

The design is a single-blind, parallel randomized controlled trial examining MBCT-TS versus m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT-TS 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.

Results

Depressive relapse/recurrence over two years is the primary outcome variable. Analyses will be conducted following CONSORT standards and overseen by the trial’s Data Monitoring and Safety Committee. Initial analyses will be conducted on an intention-to-treat basis, with subsequent analyses being per protocol. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre- and post-treatment and a qualitative study of service users’ views and experiences.

Conclusions

If the results of our exploratory trial are extended to this definitive trial, MBCT-TS will be established as an alternative approach to maintenance antidepressants 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

Trial registered 7 May 2009; ISRCTN26666654.

Keywords:
Mindfulness-based cognitive therapy; Randomised controlled trial; Depression; Antidepressant; Trial protocol