Condition category
Mental and Behavioural Disorders
Date applied
28/04/2009
Date assigned
07/05/2009
Last edited
18/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.exeter.ac.uk/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  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.

Additional files

Editorial Notes