Preventing depressive relapse/recurrence in NHS settings through mindfulness-based cognitive therapy (MBCT)

ISRCTN ISRCTN26666654
DOI https://doi.org/10.1186/ISRCTN26666654
EudraCT/CTIS number 2009-012428-10
Secondary identifying numbers HTA 08/56/01; MBCT2009
Submission date
28/04/2009
Registration date
07/05/2009
Last edited
20/11/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Willem Kuyken
Scientific

Professor of Clinical Psychology
Mood Disorders Centre
Washington Singer Laboratories
Perry Road
University of Exeter
Exeter
EX4 4QG
United Kingdom

Phone +44 (0)1392 264626
Email w.kuyken@exeter.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePreventing depressive relapse/recurrence in NHS settings through mindfulness-based cognitive therapy (MBCT): a randomised controlled trial
Study acronymMBCT
Study objectivesThe 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?"
Ethics approval(s)Not provided at time of registration – submission pending as of 28/04/2009
Health condition(s) or problem(s) studiedRecurrent depression
InterventionMindfulness-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.
Intervention typeOther
Primary outcome measureTo 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 measuresA 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.
Overall study start date02/04/2010
Completion date01/08/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants420
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment02/04/2010
Date of final enrolment01/08/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Exeter
Exeter
EX4 4QG
United Kingdom

Sponsor information

University of Exeter (UK)
University/education

c/o Helen Loughlin
Head of Research Policy
Research and Knowledge Transfer
The Innovation Centre
Rennes Drive
Exeter
EX4 4RN
England
United Kingdom

Phone +44 (0)1392 262393
Email res@ex.ac.uk
Website http://www.exeter.ac.uk/
ROR logo "ROR" https://ror.org/03yghzc09

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 20/10/2010 Yes No
Protocol article protocol update 10/06/2014 Yes No
Results article results 04/07/2015 Yes No
Results article results 01/09/2015 Yes No
Results article qualitative study results 18/02/2020 17/02/2021 Yes No
Results article Secondary analysis 01/09/2024 21/10/2024 Yes No
Results article 08/11/2024 20/11/2024 Yes No

Editorial Notes

20/11/2024: Publication reference added.
21/10/2024: Publication reference added.
17/02/2021: Publication reference added.