A randomised controlled trial of group psychoeducation with bipolar affective disorder patients.

ISRCTN	ISRCTN82941238
DOI	https://doi.org/10.1186/ISRCTN82941238
Protocol serial number	N0573157682
Sponsor	Department of Health
Funder	Newcastle, North Tyneside and Northumberland Mental Health NHS Trust (UK), NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof AH Young
Scientific

Academic Psychiatry
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does group psychoeducation reduce time to manic relapse, number of manic relapses, and improve social functioning in patients with bipolar affective disorder?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders: Bipolar disorders
Intervention	Randomised controlled trial, research with outpatients
Intervention type	Other
Primary outcome measure(s)	1. Time to manic relapse and number of manic relapses in each 6 month period. Relapse will be defined as SCID criteria for hypomania or mania. Raters (who will be blind to the randomisation) will keep in close contact with patients, keyworkers and RMOs to ensure that relapses are spotted. 2. Social functioning determined by standardised ratings at 0, 6, 12, and 18 months after randomisation. 3. MADRS and Young scores will be determined at 0, 6, 12 and 18 months after randomisation.
Key secondary outcome measure(s)	In order to provide clarification of how patients have progressed throughout the course of the study patients in both conditions will be keeping a mood diary on a daily basis. The mood diary lists a variety of symptoms associated with bipolar disorder. Each day patients will rate the severity of each of the symptoms on a 4 point scale (0=none, 4=severe).
Completion date	30/11/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	70
Key inclusion criteria	70 bipolar patients from Newcastle and North Tyneside.
Key exclusion criteria	1. Patient with learning disability, axis 1 co-morbidity, alcohol or drug dependency 2. Serious suicidal intent 3. Personality disorder 4. Organic brain disorder 5. Patients undergoing any concurrent psychological therapy 6. Bipolar disorder with a seasonal pattern
Date of first enrolment	01/12/2003
Date of final enrolment	30/11/2005

Academic Psychiatry

Newcastle upon Tyne
NE1 4LP
United Kingdom

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