MRC Multicentre randomised controlled trial of cognitive behaviour therapy in bipolar affective disorder

ISRCTN ISRCTN99884475
DOI https://doi.org/10.1186/ISRCTN99884475
Secondary identifying numbers G9721149
Submission date
23/10/2000
Registration date
23/10/2000
Last edited
05/12/2017
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

Ms Michaela Rodger
Scientific

Study Co-ordinator Academic Centre
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 OXH
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleMRC Multicentre randomised controlled trial of cognitive behaviour therapy in bipolar affective disorder
Study objectivesTo show:
1. That Cognitive Behaviour Therapy (CBT) added to usual treatment is more efficacious than usual treatment alone in reducing relapse rates and symptom levels and improving quality of life and functioning
2. That the additional costs of CBT will be offset by reductions in direct health care costs, direct non-treatment costs and indirect costs, when compared with usual treatment alone
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBipolar affective disorder
Intervention1. One group receiving cognitive behaviour therapy as well as treatment as usual
2. One group receiving only treatment as usual
Intervention typeOther
Primary outcome measure1. Recurrence of an episode of illness of sufficient severity to reach the Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) criteria for major depressive episode, manic episode or mixed episode, based on the Structured Clinical Interview (SCID)instrument
2. A longitudinal severity rating of overall symptom levels for each week since last interview (two months) based on the Longitudinal Interval Follow-up Evaluation (LIFE-II)
3. Total costs - data on all services received will be obtained using the Client/Service Receipt Inventory (CSRI; Beecham and Knapp 1992) to cover first the year prior to study entry and then every six months until the end of the follow-up period
Secondary outcome measuresNot provided at time of registration
Overall study start date01/07/1999
Completion date30/04/2003

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants220
Key inclusion criteria1. Aged 18 years or more
2. Two or more episodes
3. Last episode in previous 12 months
4. Currently/last six months in contact with mental health
5. Currently asymptomatic, depression, hypomania
Key exclusion criteria1. Cannot engage/ rapid cycling bipolar disorder (more than or equal to four episodes per year)
2. Bipolar disorder secondary to organic cause
3. Mental disorder primarily alcohol or drug related
4. Severe borderline personality disorder
5. Receiving systematic psychological treatment for bipolar disorder
6. Unable to read/write English
7. Unable to give informed consent
8. If the patients referred to the study knew the therapist when the therapist worked in a previous capacity, (e.g. as a community psychiatric nurse in a community mental health team looking after the patient), the patient would not be entered into the study
Date of first enrolment01/07/1999
Date of final enrolment30/04/2003

Locations

Countries of recruitment

  • United Kingdom

Study participating centre

Study Co-ordinator Academic Centre
Glasgow
G12 OXH
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results of preliminary investigation 01/06/2003 Yes No
Protocol article protocol 01/06/2005 Yes No
Results article results 01/05/2006 Yes No
Results article results 01/02/2007 Yes No

Editorial Notes

05/12/2017: internal review.