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.
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) 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
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.


CONCLUSIONS
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.


BACKGROUND
ISRCTN26666654.
Kuyken
Willem
W
Mood Disorders Centre, University of Exeter, UK. w.kuyken@exeter.ac.uk
Byford
Sarah
S
Byng
Richard
R
Dalgleish
Tim
T
Lewis
Glyn
G
Taylor
Rod
R
Watkins
Edward R
ER
Hayes
Rachel
R
Lanham
Paul
P
Kessler
David
D
Morant
Nicola
N
Evans
Alison
A
D000928:Antidepressive Agents / Q000191:economics / Q000627:therapeutic use*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000191:economics; D003362:Cost-Benefit Analysis; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D016527:Drug Costs; D017048:Health Care Costs; D006801:Humans; D011788:Quality of Life; D012107:Research Design; D055502:Secondary Prevention; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
D000928:Antidepressive Agents