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

ISRCTN ISRCTN82941238
DOI https://doi.org/10.1186/ISRCTN82941238
Secondary identifying numbers N0573157682
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
08/04/2014
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
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof AH Young
Scientific

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

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 objectivesDoes 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) studiedMental and Behavioural Disorders: Bipolar disorders
InterventionRandomised controlled trial, research with outpatients
Intervention typeOther
Primary outcome measure1. 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.
Secondary outcome measuresIn 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).
Overall study start date01/12/2003
Completion date30/11/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants70
Key inclusion criteria70 bipolar patients from Newcastle and North Tyneside.
Key exclusion criteria1. 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 enrolment01/12/2003
Date of final enrolment30/11/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Academic Psychiatry
Newcastle upon Tyne
NE1 4LP
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

Newcastle, North Tyneside and Northumberland Mental Health NHS Trust (UK), NHS R&D Support Funding

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