A random controlled trial to compare the efficacy of a brief psycho-educational programme with standard care plus biblio-therapy for individuals with Bipolar Disorder at high risk for relapse.

ISRCTN	ISRCTN45002938
DOI	https://doi.org/10.1186/ISRCTN45002938
Protocol serial number	N0534139816
Sponsor	Department of Health
Funder	Lambeth, Southwark and Lewisham Primary Care Trusts (UK)

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 31/03/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Mental and Behavioural Disorders

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

Contact information

Ms Mariajose Gutierrez
Scientific

Co-ordinated Psychological Treatments Service (CPTS)
The Ladywell Unit
University Hospital Lewisham
Lewisham High street
London
SE13 6LH
United Kingdom

Phone	+44
Email	mjgros@yahoo.co.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To determine if a psycho-educational intervention is associated with significant clinical improvements
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders: Bipolar disorders
Intervention	Brief psycho-educational programme vs standard care plus biblio-therapy Added 21 July 2008: trial discontinued in 2005
Intervention type	Other
Primary outcome measure(s)	Time to first relapse as assessed by independent blind reviewer.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/10/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	60
Key inclusion criteria	Subjects with bipolar disorder in contact with 3CMHT in Lewisham catchment area, inpatient units at Ladywell or by direct recruitment by GPs.
Key exclusion criteria	1. Subjects with co-morbid schizophrenia, schizo-affective disorder and psychosis 2. Subjects with severe borderline or antisocial personality disorder 3. Subjects with primary substance abuse disorder 4. Subjects suffering from an organic brain syndrome 5. Participants who currently meet DSM-IV criteria for mania, hypomania or mixed state (plus B-R> 15, &/or HRSD> 17). These patients could be admitted to the study in a later stage once they are euthymic, or mildly depressed or hypomaniac. 6. Subjects unable to read or write English 7. Subjects unable to give informed consent
Date of first enrolment	01/02/2004
Date of final enrolment	31/10/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Co-ordinated Psychological Treatments Service (CPTS)

London
SE13 6LH
United Kingdom

Results and Publications

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