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
Scientific
Academic Psychiatry
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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. |
| Secondary outcome measures | 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). |
| Overall study start date | 01/12/2003 |
| Completion date | 30/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Psychiatry
Newcastle upon Tyne
NE1 4LP
United Kingdom
NE1 4LP
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
