Psychoeducation versus cognitive-behavioral therapy in bipolar disorder
| ISRCTN | ISRCTN36852818 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36852818 |
| Protocol serial number | MCT-55404 |
| Sponsor | University of Toronto (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-55404) |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 18/04/2008
- 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
Dr Sagar V. Parikh
Scientific
Scientific
Toronto Western Hospital
Toronto
M5T 2S8
Canada
| Phone | +1 416-603-5734 |
|---|---|
| sagar_parikh@camh.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare the impact of cognitive-behavioral therapy to that of properly structured psycho education on the illness burden and functional outcome of bipolar disorder, in combination with pharmacotherapy |
| Ethics approval(s) | Centre for Addiction and Mental Health Research Ethics Board, Toronto, ON, July 9, 2001 |
| Health condition(s) or problem(s) studied | Bipolar Disorder |
| Intervention | Control group: 6 sessions of group psycho-education (topics include illness recognition, treatment approaches, and monitoring and coping strategies; based on manual by Bauer & McBride, 2002: Life Goals Phase I) Experimental group: 20 sessions of individual Cognitive Behavioural Therapy for Bipolar Disorder (topics include limited psychoeducation, activity scheduling/behavioural interventions, cognitive techniques, including thought monitoring and challenges to dysfunctional assumptions and other coping techniques; based on manual by Lam et al., 1999: Cognitive Therapy for Bipolar Disorder Trial details received: 12 Sept 2005 |
| Intervention type | Other |
| Primary outcome measure(s) |
Mania and depression |
| Key secondary outcome measure(s) |
1. Health care utilization |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 210 |
| Key inclusion criteria | 1. Bipolar I and II 2. Currently either in remission or subsyndromally ill (Ham-D-29 <14; CARS-M <12) 3. Age ≥18, either sex 4. Significant symptoms and/or episodes on at least 2 occasions in the past 3 years 5. Grade 6 education able to understand English, and Folstein Minimental Score Exam >26 to ensure cognitive ability to participate 6. On mood-stabilizing medication. |
| Key exclusion criteria | 1. Substance dependence meeting DSM-IV criteria within the last 3 months 2. Acutely high suicidal or homicidal 3. Serious other medical conditions that would render pharmacotherapy or psychotherapy very difficult i.e. cancer, severe diabetes etc. 4. Severe antisocial or borderline personality disorder |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto Western Hospital
Toronto
M5T 2S8
Canada
M5T 2S8
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
