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

ISRCTN	ISRCTN26666654
DOI	https://doi.org/10.1186/ISRCTN26666654
Clinical Trials Information System (CTIS)	2009-012428-10
Protocol serial number	HTA 08/56/01; MBCT2009
Sponsor	University of Exeter (UK)
Funder	Health Technology Assessment Programme

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(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.
Key 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.
Completion date	01/08/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

University of Exeter

Exeter
EX4 4QG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Protocol article	protocol	20/10/2010		Yes	No
Protocol article	protocol update	10/06/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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