Condition category
Mental and Behavioural Disorders
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
18/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University of Toronto (Canada)

Sponsor details

27 King's College Circle
Toronto
M5S 1A1
Canada

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes