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 |
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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
Scientific
Co-ordinated Psychological Treatments Service (CPTS)
The Ladywell Unit
University Hospital Lewisham
Lewisham High street
London
SE13 6LH
United Kingdom
Phone | +44 |
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mjgros@yahoo.co.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 | Time to first relapse as assessed by independent blind reviewer. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/02/2004 |
Completion date | 31/10/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
Co-ordinated Psychological Treatments Service (CPTS)
London
SE13 6LH
United Kingdom
SE13 6LH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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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 |