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Trial platform: preventing depression relapse in the National Health Service practice using Mindfulness-Based Cognitive Therapy
ISRCTN ISRCTN12720810
DOI 10.1186/ISRCTN12720810
ClinicalTrials.gov identifier
EudraCT number
Public title Trial platform: preventing depression relapse in the National Health Service practice using Mindfulness-Based Cognitive Therapy
Scientific title
Acronym MBCT
Serial number at source G0401161
Study hypothesis Aims:
1. To carry out preparatory work necessary to design and conduct an adequately powered, well-controlled, multi-centre randomised controlled effectiveness study of the generalisability of MBCT to real-world National Health Service (NHS) practice settings comparing it to the current treatment of choice (anti-depressant medication)
2. To examine key mechanisms that enhance recovery and prevent relapse via a pilot process-outcome study.

Objectives:
1. To integrate MBCT into selected primary care service contexts
2. To fully cost MBCT
3. To establish patient throughput numbers
4. To develop training and supervision packages for MBCT therapists
5. To pilot measures of mechanisms of change, health status and cost-effectiveness
6. To estimate MBCT effect sizes in real-world conditions
7. To resolve methodology/design issues for the phase IV study, including necessary sample size (based on points one, two & five above), feasibility/method of randomising patients with remitted depression to pharmacological and MBCT treatment arms and optimal follow-up periods
Lay summary Not provided at time of registration
Ethics approval North and East Devon research ethics committee project (reference number: 05/Q2102/77)
approval given 8th August 2005.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Depression
Participants - inclusion criteria 1. Three or more previous episodes of depression meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (including the current episode)
2. Aged 18 or older
3. Currently in either partial or full remission from last episode of depression
Participants - exclusion criteria Co-morbid psychiatric diagnoses that would:
1. Interfere with engaging with MBCT (current substance dependence)
2. Be exacerbated by MBCT (psychosis, very disabling obsessive compulsive disorder) and formal concurrent psychotherapy
Anticipated start date 01/09/2005
Anticipated end date 30/09/2007
Status of trial Completed
Patient information material
Target number of participants 40 in MBCT and 40 in continuation anti-depressants
Interventions Continuation anti-depressants or Mindfulness-based Cognitive Therapy.
Primary outcome measure(s) In line with previous MBCT randomised controlled trials (RCTs), the primary outcome measure will be a recurrence of depression meeting DSM-IV criteria.
Secondary outcome measure(s) Secondary outcome measures will be residual depressive symptoms (measured by the interviewer-rated Hamilton Depression Scale and self-report Beck Depression Inventory). In line with effectiveness trials examining an interventionís generalisability, a novel feature of this study will be extending outcome assessment to health status (using the Medical Outcomes Study [MOS SF-12] instrument), quality of life (using the World Health Organisation Quality of Life [WHOQOL-BREF] instrument), and health costs (using Client Service Receipt Inventory adapted for depression relapse studies).
Sources of funding Medical Research Council (MRC) (UK) (ref: G0401161)
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19045965
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19508744
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20109277
4. 2012 results of sub-study on effect on parenting in http://www.ncbi.nlm.nih.gov/pubmed/21429979
Contact name Dr  Willem  Kuyken
  Address University of Exeter
Mood Disorders Centre
School of Psychology
Perry Road
  City/town Exeter
  Zip/Postcode EX4 4QG
  Country United Kingdom
  Email w.kuyken@exeter.ac.uk
Sponsor University of Exeter (UK)
  Address School of Psychology
Perry Road
  City/town Exeter
  Zip/Postcode EX4 4QG
  Country United Kingdom
  Email w.kuyken@exeter.ac.uk
  Sponsor website: http://www.exeter.ac.uk/
Date applied 27/06/2006
Last edited 31/07/2012
Date ISRCTN assigned 31/08/2006
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