Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtain treatment

ISRCTN ISRCTN21277091
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

Department of Community Psychiatry
University of Manchester
Withington Hospital
Manchester
M20 8LR
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedSchizophrenia and other psychoses
Intervention7 - 12 intervention treatment sessions from a research psychologist plus routine care versus routine care only.
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/03/1994
Completion date01/04/1997

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants69
Key inclusion criteria1. 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 criteria1. 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 enrolment01/03/1994
Date of final enrolment01/04/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Community Psychiatry
Manchester
M20 8LR
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
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 16/01/1999 Yes No