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 |
| Secondary identifying numbers | 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
Not provided at time of registration
Contact information
Dr Willem Kuyken
Scientific
Scientific
University of Exeter
Mood Disorders Centre
School of Psychology
Perry Road
Exeter
EX4 4QG
United Kingdom
| w.kuyken@exeter.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study 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(s) | North and East Devon research ethics committee project (reference number: 05/Q2102/77) approval given 8th August 2005. |
| Condition | Depression |
| Intervention | Continuation anti-depressants or Mindfulness-based Cognitive Therapy. |
| Intervention type | Other |
| Primary outcome measure | 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 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). |
| Overall study start date | 01/09/2005 |
| Overall study end date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 in MBCT and 40 in continuation anti-depressants |
| 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 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
- England
- United Kingdom
Study participating centre
University of Exeter
Exeter
EX4 4QG
United Kingdom
EX4 4QG
United Kingdom
Sponsor information
University of Exeter (UK)
University/education
University/education
School of Psychology
Perry Road
Exeter
EX4 4QG
England
United Kingdom
| w.kuyken@exeter.ac.uk | |
| Website | http://www.exeter.ac.uk/ |
"ROR" |
https://ror.org/03yghzc09 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) (ref: G0401161)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | 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 |
