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
Protocol serial number	N/A
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive North West (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Richard Morriss
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/04/1997

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Department of Community Psychiatry

Manchester
M20 8LR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	16/01/1999		Yes	No