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ISRCTN
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ISRCTN36852818
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ClinicalTrials.gov identifier
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Public title
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Psychoeducation versus cognitive-behavioral therapy in bipolar disorder
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Scientific title
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Acronym
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N/A
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Serial number at source
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MCT-55404
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Centre for Addiction and Mental Health Research Ethics Board, Toronto, ON, July 9, 2001
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Bipolar Disorder
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2002
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Anticipated end date
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31/03/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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210
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Interventions
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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
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Primary outcome measure(s)
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Mania and depression
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Secondary outcome measure(s)
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1. Health care utilization
2. Social and occupational functioning scales
3. Quality of life
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-55404)
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Trial website
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Publications
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Contact name
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Dr
Sagar V.
Parikh
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Address
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Toronto Western Hospital
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City/town
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Toronto
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Zip/Postcode
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M5T 2S8
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Country
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Canada
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Tel
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+1 416-603-5734
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Fax
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+1 416-603-5039
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Email
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sagar_parikh@camh.net
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Sponsor
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University of Toronto (Canada)
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Address
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27 King's College Circle
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City/town
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Toronto
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Zip/Postcode
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M5S 1A1
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Country
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Canada
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Date applied
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26/09/2005
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Last edited
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18/04/2008
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Date ISRCTN assigned
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26/09/2005
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