Welcome
Support Centre
23 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Preventing depressive relapse/recurrence in NHS settings through mindfulness-based cognitive therapy (MBCT)
ISRCTN ISRCTN26666654
DOI 10.1186/ISRCTN26666654
ClinicalTrials.gov identifier
EudraCT number 2009-012428-10
Public title Preventing depressive relapse/recurrence in NHS settings through mindfulness-based cognitive therapy (MBCT)
Scientific title Preventing depressive relapse/recurrence in NHS settings through mindfulness-based cognitive therapy (MBCT): a randomised controlled trial
Acronym MBCT
Serial number at source HTA 08/56/01; MBCT2009
Study hypothesis The pragmatic aim of the proposed trial is to establish whether Mindfulness-based Cognitive Therapy (MBCT) provides an effective alternative relapse prevention approach to maintenance anti-depressant medication (m-ADM) in primary care settings for patients with a history of recurrent depression.

We ask a primary 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) anti-depressant (ADM) usage, (d) psychiatric co-morbidity, (e) quality of life, and (f) cost effectiveness?"

We ask subsidiary interlinked explanatory questions: "Is an increase in mindfulness skills the key mechanism of change?"
Lay summary Not provided at time of registration
Ethics approval To be submitted as of 28/04/2009
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Recurrent depression
Participants - inclusion criteria 1. A diagnosis of recurrent major depressive disorder in full or partial remission according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), with 3 or more previous major depressive episodes
2. Both males and females, aged 18 or older
3. Patients on a therapeutic dose of ADM in line with the British National Formulary (BNF) and the National Institute for Health and Clinical Excellence (NICE) guidance
Participants - exclusion criteria 1. Co-morbid diagnoses of current substance dependence
2. Organic brain damage
3. Current/past psychosis, including bipolar disorder
4. Persistent anti-social behaviour
5. Persistent self-injury requiring clinical management/therapy
6. Formal concurrent psychotherapy
Anticipated start date 02/04/2010
Anticipated end date 01/08/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 420
Interventions Mindfulness-based Cognitive Therapy (MBCT, see http://www.mbct.co.uk). MBCT is an 8-week, group based programme (8-15 patients per group) designed to teach people skills that prevent depressive relapse/recurrence. It is a fully manualised psychosocial intervention with the treatment rationale for each session outlined in full. MBCT is based on theoretical and empirical work demonstrating that depressive relapse is associated with the reinstatement of automatic modes of thinking, feeling and behaving that are counter-productive in contributing to depressive relapse and recurrence. Participants learn to recognize these "automatic pilot" modes, decentre from them and use healthier coping methods. MBCT is an accessible and acceptable treatment as evidenced by low attrition in trials (<10%) and shows very promising evidence of efficacy.

The control group will continue to take maintenance anti-depressant medication for the duration of the trial.
Primary outcome measure(s) To determine whether MBCT is superior to maintenance antidepressant medication (m-ADM) in preventing depression relapse/recurrence over 24 months for patients with a history of recurrent depression.
Secondary outcome measure(s) A unique aspect of our trial is the inclusion of a range of secondary outcome measures including those highly valued by patients themselves. We will be comparing the following:
1. Number of depression free days
2. Residual depressive symptoms
3. Anti-depressant usage
4. Psychiatric co-morbidity
5. Quality of life, assessed by Euroqol EQ-5D
6. Cost effectiveness

A further secondary objective is to determine whether an increase in mindfulness skills is the key mechanism of change.

All outcome measures will be taken at 3, 6, 12, 18 and 24 months post baseline.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20961444
2014 protocol update in: http://www.ncbi.nlm.nih.gov/pubmed/24916319
Contact name Prof  Willem  Kuyken
  Address Professor of Clinical Psychology
Mood Disorders Centre
Washington Singer Laboratories
Perry Road
University of Exeter
  City/town Exeter
  Zip/Postcode EX4 4QG
  Country United Kingdom
  Tel +44 (0)1392 264626
  Fax +44 (0)1392 264623
  Email w.kuyken@exeter.ac.uk
Sponsor University of Exeter (UK)
  Address c/o Helen Loughlin
Head of Research Policy
Research and Knowledge Transfer
The Innovation Centre
Rennes Drive
  City/town Exeter
  Zip/Postcode EX4 4RN
  Country United Kingdom
  Tel +44 (0)1392 262393
  Fax +44 (0)1392 263686
  Email res@ex.ac.uk
  Sponsor website: http://www.exeter.ac.uk/
Date applied 28/04/2009
Last edited 12/06/2014
Date ISRCTN assigned 07/05/2009
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.