title: 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.
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.
  
  
  BACKGROUND
  Trial registered 7 May 2009; ISRCTN26666654.
authors.affiliation: Mood Disorders Centre, School of Psychology, Perry Road, University of Exeter, Exeter EX4 4QG, UK. w.kuyken@exeter.ac.uk.
authors.forename: Willem
authors.initials: W
authors.lastname: Kuyken
authors.forename: Sarah
authors.initials: S
authors.lastname: Byford
authors.forename: Richard
authors.initials: R
authors.lastname: Byng
authors.forename: Tim
authors.initials: T
authors.lastname: Dalgleish
authors.forename: Glyn
authors.initials: G
authors.lastname: Lewis
authors.forename: Rod
authors.initials: R
authors.lastname: Taylor
authors.forename: Edward R
authors.initials: ER
authors.lastname: Watkins
authors.forename: Rachel
authors.initials: R
authors.lastname: Hayes
authors.forename: Paul
authors.initials: P
authors.lastname: Lanham
authors.forename: David
authors.initials: D
authors.lastname: Kessler
authors.forename: Nicola
authors.initials: N
authors.lastname: Morant
authors.forename: Alison
authors.initials: A
authors.lastname: Evans
mesh_terms: D000928:Antidepressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D054976:Clinical Governance; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003865:Major Depressive Disorder / Q000188:drug therapy / Q000517:prevention & control / Q000523:psychology; D006801:Humans; D064866:Mindfulness / Q000379:methods*; D012107:Research Design; D055502:Secondary Prevention; D013375:Substance Withdrawal Syndrome / Q000523:psychology
chemical_list: D000928:Antidepressive Agents