Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT00188838|
Recruitment Status : Unknown
Verified July 2005 by University Health Network, Toronto.
Recruitment status was: Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
To examine the impact of cognitive-behavioural therapy on both the episodic and functional outcome of bipolar disorder, in combination with pharmacotherapy.
Primary Hypothesis is twofold:
- Cognitive Behavioural Therapy will reduce the total symptom burden, as measured both by percentage of time spent ill (both syndromic and subsyndromal) and number of episodes, as compared to psychoeducation
- Cognitive behavioural therapy will reduce social and occupational disability to a greater extent than psychoeducation.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Behavioral: Psychoeduction Behavioral: Cognitive-Behavioral Therapy||Not Applicable|
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.
Subjects will be randomized to either a "control" treatment group cosisting of 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) or they will be randomized to the "experimental" treatment 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)
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder|
|Study Start Date :||July 2002|
|Study Completion Date :||August 2006|
- Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).
- Modified Social Adjustment Scale (SAS II-B; Bauer, 2001)
- ***Note: all primary outcomes obtained prospectively every 3 months for 18 months
- Clinician Administered Rating Scale for Mania
- Hamilton Depression Rating Scale
- Quality of Life, Enjoyment, and Satisfaction Questionnaire
- Dysfunctional Attitudes Scale
- Patient Satisfaction Index
- Activity and Utilisation Questionnaire
- Medication Compliance scale
- Intensity of Somatotherapy Index
- Coping Inventory for Prodromes of Mania
- Khavari Alcohol Test.
- *****Note: all secondary outcomes measured prospectively over 18 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188838
|Canada, British Columbia|
|University of British Columbia, Department of Psychiatry|
|Vancouver, British Columbia, Canada, V6T-2A1|
|St. Joseph's Healthcare, CMHS|
|Hamilton, Ontario, Canada, L8N-3K7|
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5T-1R8|
|University Health Network|
|Toronto, Ontario, Canada, M5T-2S8|
|McGill University Health Centre|
|Montreal, Quebec, Canada, H3G-1A4|
|Douglas Hospital-McGill University|
|Verdun, Quebec, Canada, H4G-1E2|
|Principal Investigator:||Sagar V Parikh, M.D.||University Health Network, Toronto|