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
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 |
---|---|
w.kuyken@exeter.ac.uk |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Prevention |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Preventing depressive relapse/recurrence in NHS settings through mindfulness-based cognitive therapy (MBCT): a randomised controlled trial |
Study acronym | MBCT |
Study objectives | 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?" |
Ethics approval(s) | Not provided at time of registration – submission pending as of 28/04/2009 |
Health condition(s) or problem(s) studied | Recurrent depression |
Intervention | 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. |
Intervention type | Other |
Primary outcome measure | 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 measures | 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. |
Overall study start date | 02/04/2010 |
Completion date | 01/08/2013 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 420 |
Key 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 |
Key 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 |
Date of first enrolment | 02/04/2010 |
Date of final enrolment | 01/08/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Exeter
Exeter
EX4 4QG
United Kingdom
EX4 4QG
United Kingdom
Sponsor information
University of Exeter (UK)
University/education
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 |
---|---|
res@ex.ac.uk | |
Website | http://www.exeter.ac.uk/ |
https://ror.org/03yghzc09 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.