title: Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse or recurrence (PREVENT): a randomised controlled trial.
abstract: BACKGROUND
  Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence. Maintenance antidepressants for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to medication. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce risk of relapse or recurrence compared with usual care, but has not yet been compared with maintenance antidepressant treatment in a definitive trial. We aimed to see whether MBCT with support to taper or discontinue antidepressant treatment (MBCT-TS) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months.
  
  
  METHODS
  In this single-blind, parallel, group randomised controlled trial (PREVENT), we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants, from primary care general practices in urban and rural settings in the UK. Participants were randomly assigned to either MBCT-TS or maintenance antidepressants (in a 1:1 ratio) with a computer-generated random number sequence with stratification by centre and symptomatic status. Participants were aware of treatment allocation and research assessors were masked to treatment allocation. The primary outcome was time to relapse or recurrence of depression, with patients followed up at five separate intervals during the 24-month study period. The primary analysis was based on the principle of intention to treat. The trial is registered with Current Controlled Trials, ISRCTN26666654.
  
  
  RESULTS
  Between March 23, 2010, and Oct 21, 2011, we assessed 2188 participants for eligibility and recruited 424 patients from 95 general practices. 212 patients were randomly assigned to MBCT-TS and 212 to maintenance antidepressants. The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months (hazard ratio 0·89, 95% CI 0·67-1·18; p=0·43), nor did the number of serious adverse events. Five adverse events were reported, including two deaths, in each of the MBCT-TS and maintenance antidepressants groups. No adverse events were attributable to the interventions or the trial.
  
  
  CONCLUSIONS
  We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence. Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence, residual depressive symptoms, and quality of life.
  
  
  BACKGROUND
  National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.
authors.affiliation: Department of Psychiatry, University of Oxford, Oxford, UK; Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK. Electronic address: willem.kuyken@psych.ox.ac.uk.
authors.forename: Willem
authors.initials: W
authors.lastname: Kuyken
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Rachel
authors.initials: R
authors.lastname: Hayes
authors.affiliation: Centre for the Economics of Mental and Physical Health, King's College London, London, UK.
authors.forename: Barbara
authors.initials: B
authors.lastname: Barrett
authors.affiliation: Primary Care Group, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Byng
authors.affiliation: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Dalgleish
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: David
authors.initials: D
authors.lastname: Kessler
authors.affiliation: Division of Psychiatry, University College London, London, UK.
authors.forename: Glyn
authors.initials: G
authors.lastname: Lewis
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Edward
authors.initials: E
authors.lastname: Watkins
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Brejcha
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Jessica
authors.initials: J
authors.lastname: Cardy
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Aaron
authors.initials: A
authors.lastname: Causley
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Cowderoy
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Evans
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Felix
authors.initials: F
authors.lastname: Gradinger
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Surinder
authors.initials: S
authors.lastname: Kaur
authors.affiliation: Clifton, Bedfordshire, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Lanham
authors.affiliation: Department of Psychology, University of Cambridge, Cambridge, UK.
authors.forename: Nicola
authors.initials: N
authors.lastname: Morant
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Richards
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Pooja
authors.initials: P
authors.lastname: Shah
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Harry
authors.initials: H
authors.lastname: Sutton
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Rachael
authors.initials: R
authors.lastname: Vicary
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Alice
authors.initials: A
authors.lastname: Weaver
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Jenny
authors.initials: J
authors.lastname: Wilks
authors.affiliation: Mood Disorders Centre, Psychology, University of Exeter, Exeter, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Williams
authors.affiliation: Exeter Medical School, University of Exeter, Exeter, UK.
authors.forename: Rod S
authors.initials: RS
authors.lastname: Taylor
authors.affiliation: Centre for the Economics of Mental and Physical Health, King's College London, London, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Byford
mesh_terms: D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D003865:Major Depressive Disorder / Q000188:drug therapy / Q000517:prevention & control*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D064866:Mindfulness / Q000379:methods*; D011788:Quality of Life; D012008:Recurrence; D016037:Single-Blind Method; D012959:Socioeconomic Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents