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| [ Print-friendly version ] |
| Preventing depressive relapse/recurrence in NHS settings through mindfulness-based cognitive therapy (MBCT) |
| ISRCTN | ISRCTN26666654 |
| ClinicalTrials.gov identifier | |
| Public title | Preventing depressive relapse/recurrence in NHS settings through mindfulness-based cognitive therapy (MBCT) |
| Scientific title | Preventing depressive relapse/recurrence in NHS settings through mindfulness-based cognitive therapy (MBCT): a randomised controlled trial |
| Acronym | MBCT |
| Serial number at source | HTA 08/56/01; MBCT2009 |
| 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?" |
| Lay summary | |
| Ethics approval | To be submitted as of 28/04/2009 |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Recurrent depression |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 02/04/2010 |
| Anticipated end date | 01/08/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 420 |
| Interventions |
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. |
| Primary outcome measure(s) | 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 measure(s) |
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. |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20961444 |
| Contact name | Prof Willem Kuyken |
| Address |
Professor of Clinical Psychology
Mood Disorders Centre Washington Singer Laboratories Perry Road University of Exeter |
| City/town | Exeter |
| Zip/Postcode | EX4 4QG |
| Country | United Kingdom |
| Tel | +44 (0)1392 264626 |
| Fax | +44 (0)1392 264623 |
| w.kuyken@exeter.ac.uk | |
| Sponsor | University of Exeter (UK) |
| Address |
c/o Helen Loughlin
Head of Research Policy Research and Knowledge Transfer The Innovation Centre Rennes Drive |
| City/town | Exeter |
| Zip/Postcode | EX4 4RN |
| Country | United Kingdom |
| Tel | +44 (0)1392 262393 |
| Fax | +44 (0)1392 263686 |
| res@ex.ac.uk | |
| Sponsor website: | http://www.exeter.ac.uk/ |
| Date applied | 28/04/2009 |
| Last edited | 10/11/2010 |
| Date ISRCTN assigned | 07/05/2009 |
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