Condition category
Mental and Behavioural Disorders
Date applied
27/06/2006
Date assigned
31/08/2006
Last edited
31/07/2012
Prospective/Retrospective
Retrospectively 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

Dr Willem Kuyken

ORCID ID

Contact details

University of Exeter
Mood Disorders Centre
School of Psychology
Perry Road
Exeter
EX4 4QG
United Kingdom
w.kuyken@exeter.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0401161

Study information

Scientific title

Acronym

MBCT

Study hypothesis

Aims:
1. To carry out preparatory work necessary to design and conduct an adequately powered, well-controlled, multi-centre randomised controlled effectiveness study of the generalisability of MBCT to real-world National Health Service (NHS) practice settings comparing it to the current treatment of choice (anti-depressant medication)
2. To examine key mechanisms that enhance recovery and prevent relapse via a pilot process-outcome study.

Objectives:
1. To integrate MBCT into selected primary care service contexts
2. To fully cost MBCT
3. To establish patient throughput numbers
4. To develop training and supervision packages for MBCT therapists
5. To pilot measures of mechanisms of change, health status and cost-effectiveness
6. To estimate MBCT effect sizes in real-world conditions
7. To resolve methodology/design issues for the phase IV study, including necessary sample size (based on points one, two & five above), feasibility/method of randomising patients with remitted depression to pharmacological and MBCT treatment arms and optimal follow-up periods

Ethics approval

North and East Devon research ethics committee project (reference number: 05/Q2102/77)
approval given 8th August 2005.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Depression

Intervention

Continuation anti-depressants or Mindfulness-based Cognitive Therapy.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

In line with previous MBCT randomised controlled trials (RCTs), the primary outcome measure will be a recurrence of depression meeting DSM-IV criteria.

Secondary outcome measures

Secondary outcome measures will be residual depressive symptoms (measured by the interviewer-rated Hamilton Depression Scale and self-report Beck Depression Inventory). In line with effectiveness trials examining an intervention’s generalisability, a novel feature of this study will be extending outcome assessment to health status (using the Medical Outcomes Study [MOS SF-12] instrument), quality of life (using the World Health Organisation Quality of Life [WHOQOL-BREF] instrument), and health costs (using Client Service Receipt Inventory adapted for depression relapse studies).

Overall trial start date

01/09/2005

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Three or more previous episodes of depression meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (including the current episode)
2. Aged 18 or older
3. Currently in either partial or full remission from last episode of depression

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 in MBCT and 40 in continuation anti-depressants

Participant exclusion criteria

Co-morbid psychiatric diagnoses that would:
1. Interfere with engaging with MBCT (current substance dependence)
2. Be exacerbated by MBCT (psychosis, very disabling obsessive compulsive disorder) and formal concurrent psychotherapy

Recruitment start date

01/09/2005

Recruitment end date

30/09/2007

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

School of Psychology
Perry Road
Exeter
EX4 4QG
United Kingdom
w.kuyken@exeter.ac.uk

Sponsor type

University/education

Website

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

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0401161)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19045965
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19508744
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20109277
4. 2012 results of sub-study on effect on parenting in http://www.ncbi.nlm.nih.gov/pubmed/21429979

Publication citations

  1. Results

    Kuyken W, Byford S, Taylor RS, Watkins E, Holden E, White K, Barrett B, Byng R, Evans A, Mullan E, Teasdale JD, Mindfulness-based cognitive therapy to prevent relapse in recurrent depression., J Consult Clin Psychol, 2008, 76, 6, 966-978, doi: 10.1037/a0013786.

  2. Results

    Allen M, Bromley A, Kuyken W, Sonnenberg SJ, Participants' experiences of mindfulness-based cognitive therapy: "It changed me in just about every way possible"., Behav Cogn Psychother, 2009, 37, 4, 413-430, doi: 10.1017/S135246580999004X.

  3. Results

    Pearson KA, Watkins ER, Kuyken W, Mullan EG, The psychosocial context of depressive rumination: ruminative brooding predicts diminished relationship satisfaction in individuals with a history of past major depression., Br J Clin Psychol, 2010, 49, Pt 2, 275-280, doi: 10.1348/014466509X480553.

  4. Bailie C, Kuyken W, Sonnenberg S, The experiences of parents in mindfulness-based cognitive therapy., Clin Child Psychol Psychiatry, 2012, 17, 1, 103-119, doi: 10.1177/1359104510392296.

Additional files

Editorial Notes