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
Secondary identifying numbers N0534139816
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo 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) studiedMental and Behavioural Disorders: Bipolar disorders
InterventionBrief psycho-educational programme vs standard care plus biblio-therapy

Added 21 July 2008: trial discontinued in 2005
Intervention typeOther
Primary outcome measureTime to first relapse as assessed by independent blind reviewer.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/02/2004
Completion date31/10/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants60
Key inclusion criteriaSubjects with bipolar disorder in contact with 3CMHT in Lewisham catchment area, inpatient units at Ladywell or by direct recruitment by GPs.
Key exclusion criteria1. 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 enrolment01/02/2004
Date of final enrolment31/10/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Co-ordinated Psychological Treatments Service (CPTS)
London
SE13 6LH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Lambeth, Southwark and Lewisham Primary Care Trusts (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