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
Scientific
Study Co-ordinator Academic Centre
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 OXH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | MRC Multicentre randomised controlled trial of cognitive behaviour therapy in bipolar affective disorder |
| Study objectives | To 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) studied | Bipolar affective disorder |
| Intervention | 1. One group receiving cognitive behaviour therapy as well as treatment as usual 2. One group receiving only treatment as usual |
| Intervention type | Other |
| Primary outcome measure | 1. 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 measures | Not provided at time of registration |
| Overall study start date | 01/07/1999 |
| Completion date | 30/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 220 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/07/1999 |
| Date of final enrolment | 30/04/2003 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Study Co-ordinator Academic Centre
Glasgow
G12 OXH
United Kingdom
G12 OXH
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| 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
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 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.
