Trial platform: preventing depression relapse in the National Health Service practice using Mindfulness-Based Cognitive Therapy

ISRCTN	ISRCTN12720810
DOI	https://doi.org/10.1186/ISRCTN12720810
Protocol serial number	G0401161
Sponsor	University of Exeter (UK)
Funder	Medical Research Council (MRC) (UK) (ref: G0401161)

Submission date: 27/06/2006
Registration date: 31/08/2006
Last edited: 31/07/2012

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

Dr Willem Kuyken
Scientific

University of Exeter
Mood Disorders Centre
School of Psychology
Perry Road
Exeter
EX4 4QG
United Kingdom

Email	w.kuyken@exeter.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MBCT
Study objectives	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(s)	North and East Devon research ethics committee project (reference number: 05/Q2102/77) approval given 8th August 2005.
Health condition(s) or problem(s) studied	Depression
Intervention	Continuation anti-depressants or Mindfulness-based Cognitive Therapy.
Intervention type	Other
Primary outcome measure(s)	In line with previous MBCT randomised controlled trials (RCTs), the primary outcome measure will be a recurrence of depression meeting DSM-IV criteria.
Key secondary outcome measure(s)	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 interventions 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).
Completion date	30/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	01/09/2005
Date of final enrolment	30/09/2007

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	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/12/2008	Yes	No
Results article	results	01/07/2009	Yes	No
Results article	results	01/06/2010	Yes	No
Results article	results of sub-study on effect on parenting	01/01/2012	Yes	No