Contact information
Type
Scientific
Primary contact
Dr Sagar V. Parikh
ORCID ID
Contact details
Toronto Western Hospital
Toronto
M5T 2S8
Canada
+1 416-603-5734
sagar_parikh@camh.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-55404
Study information
Scientific title
Acronym
Study hypothesis
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
Centre for Addiction and Mental Health Research Ethics Board, Toronto, ON, July 9, 2001
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Mania and depression
Secondary outcome measures
1. Health care utilization
2. Social and occupational functioning scales
3. Quality of life
Overall trial start date
01/04/2002
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
210
Participant 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
Recruitment start date
01/04/2002
Recruitment end date
31/03/2005
Locations
Countries of recruitment
Canada
Trial participating centre
Toronto Western Hospital
Toronto
M5T 2S8
Canada
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-55404)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary