Psychoeducation versus cognitive-behavioral therapy in bipolar disorder

ISRCTN	ISRCTN36852818
DOI	https://doi.org/10.1186/ISRCTN36852818
Secondary identifying numbers	MCT-55404

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

Dr Sagar V. Parikh
Scientific

Toronto Western Hospital
Toronto
M5T 2S8
Canada

Phone	+1 416-603-5734
Email	sagar_parikh@camh.net

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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	Mania and depression
Secondary outcome measures	1. Health care utilization 2. Social and occupational functioning scales 3. Quality of life
Overall study start date	01/04/2002
Completion date	31/03/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Toronto Western Hospital

Toronto
M5T 2S8
Canada

University of Toronto (Canada)
Not defined

27 King's College Circle
Toronto
M5S 1A1
Canada

"ROR"	https://ror.org/03dbr7087

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-55404)

No information available

Intention to publish date
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