Contact information
Type
Scientific
Primary contact
Prof Willem Kuyken
ORCID ID
Contact details
Professor of Clinical Psychology
Mood Disorders Centre
Washington Singer Laboratories
Perry Road
University of Exeter
Exeter
EX4 4QG
United Kingdom
+44 (0)1392 264626
w.kuyken@exeter.ac.uk
Additional identifiers
EudraCT number
2009-012428-10
ClinicalTrials.gov number
Protocol/serial number
HTA 08/56/01; MBCT2009
Study information
Scientific title
Preventing depressive relapse/recurrence in NHS settings through mindfulness-based cognitive therapy (MBCT): a randomised controlled trial
Acronym
MBCT
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?"
Ethics approval
Not provided at time of registration – submission pending as of 28/04/2009
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
02/04/2010
Overall trial end date
01/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
420
Participant 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
Recruitment start date
02/04/2010
Recruitment end date
01/08/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Exeter
Exeter
EX4 4QG
United Kingdom
Sponsor information
Organisation
University of Exeter (UK)
Sponsor details
c/o Helen Loughlin
Head of Research Policy
Research and Knowledge Transfer
The Innovation Centre
Rennes Drive
Exeter
EX4 4RN
United Kingdom
+44 (0)1392 262393
res@ex.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20961444
2014 protocol update in: http://www.ncbi.nlm.nih.gov/pubmed/24916319
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25907157
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26379122
Publication citations
-
Protocol
Kuyken W, Byford S, Byng R, Dalgleish T, Lewis G, Taylor R, Watkins ER, Hayes R, Lanham P, Kessler D, Morant N, Evans A, Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial., Trials, 2010, 11, 99, doi: 10.1186/1745-6215-11-99.
-
Protocol update
Kuyken W, Byford S, Byng R, Dalgleish T, Lewis G, Taylor R, Watkins ER, Hayes R, Lanham P, Kessler D, Morant N, Evans A, Update to the study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment depressive relapse/recurrence: the PREVENT trial., Trials, 2014, 15, 217, doi: 10.1186/1745-6215-15-217.
-
Results
W Kuyken, R Hayes, B Barrett , R Byng, T Dalgleish, D Kessler, G Lewis, E Watkins, C Brejcha, J Cardy, A Causley, S Cowderoy, A Evans, F Gradinger, S Kaur, P Lanham, N Morant, J Richards, P Shah, H Sutton, Vicary, A Weaver, J Wilks, M Williams, RS Taylor, S Byford, Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse or recurrence (PREVENT): a randomised controlled trial, Lancet, 2015, 386, 9988, 63-73, doi: 10.1016/S0140-6736(14)62222-4.
-
Results
Kuyken W, Hayes R, Barrett B, Byng R, Dalgleish T, Kessler D, Lewis G, Watkins E, Morant N, Taylor RS, Byford S, The effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse/recurrence: results of a randomised controlled trial (the PREVENT study), Health Technol Assess, 2015 , 19, 73, 1-124.