Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtain treatment
ISRCTN | ISRCTN21277091 |
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DOI | https://doi.org/10.1186/ISRCTN21277091 |
Secondary identifying numbers | N/A |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 01/06/2009
- 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 Richard Morriss
Scientific
Scientific
Department of Community Psychiatry
University of Manchester
Withington Hospital
Manchester
M20 8LR
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | To determine the efficacy of teaching patients with bipolar disorder (manic-depressive psychosis) to identify early symptoms of relapse and seek prompt treatment from health services. |
Ethics approval(s) | The study was approved by a medical ethics committee in each NHS trust. Each patient gave written informed consent to the trial. |
Health condition(s) or problem(s) studied | Schizophrenia and other psychoses |
Intervention | 7 - 12 intervention treatment sessions from a research psychologist plus routine care versus routine care only. |
Intervention type | Other |
Primary outcome measure | 1. Time to first manic or depressive relapse 2. Number of manic or depressive relapses 3. Social functioning examined by standardised interviews every six months for 18 months |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/03/1994 |
Completion date | 01/04/1997 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 69 |
Key inclusion criteria | 1. A lifetime diagnosis of bipolar disorder elicited by a trained research assistant using a standardised psychiatric interview 2. Two or more relapses 3. One in the previous 12 months 4. Aged 18 to 75 years |
Key exclusion criteria | 1. An inability to read or write in English 2. Drug or alcohol misuse or dependence as a primary problem 3. An organic cerebral cause for bipolar disorder, e.g., multiple sclerosis or stroke |
Date of first enrolment | 01/03/1994 |
Date of final enrolment | 01/04/1997 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Community Psychiatry
Manchester
M20 8LR
United Kingdom
M20 8LR
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive North West (UK)
No information available
Results and Publications
Intention to publish date | |
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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 | 16/01/1999 | Yes | No |