Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

September 12, 2005 updated by: University Health Network, Toronto

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:

  1. 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
  2. Cognitive behavioural therapy will reduce social and occupational disability to a greater extent than psychoeducation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective:

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.

Interventions:

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

Enrollment

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T-2A1
        • University of British Columbia, Department of Psychiatry
    • Ontario
      • Hamilton, Ontario, Canada, L8N-3K7
        • St. Joseph's Healthcare, CMHS
      • Toronto, Ontario, Canada, M5T-1R8
        • Centre for Addiction and Mental Health
      • Toronto, Ontario, Canada, M5T-2S8
        • University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H3G-1A4
        • Mcgill University Health Centre
      • Verdun, Quebec, Canada, H4G-1E2
        • Douglas Hospital-McGill University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Bipolar I or II
  2. Currently either in remission or subsyndromally ill (Hamilton Depression Scale-17<14; Clinician Administered Rating Scale for Mania<12).
  3. Age eighteen to sixty.
  4. Significant symptoms and/or episodes on at least two occasions in the past three years.
  5. Grade six education, able to understand English, and Folstein Minimental Score Exam > 26 to ensure cognitive ability to participate.
  6. On mood-stabilizing medication.

Exclusion Criteria:

  1. Substance dependence meeting Diagnostic and Statistical Manual of Mental Disorders-IV criteria within the last three months.
  2. Acutely highly suicidal or homicidal.
  3. Serious other medical condition that would render pharmacotherapy or psychotherapy very difficult such as cancer, severe diabetes, etc.
  4. Severe antisocial or borderline personality disorder (personality disorder per se is not exclusionary). Subjects may have other axis I disorders, but bipolar disorder must be the principal disorder requiring treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

Outcome Measure
Hamilton Depression Rating Scale
Clinician Administered Rating Scale for Mania
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Stanley Medical Research Institute

Investigators

  • Principal Investigator: Sagar V Parikh, M.D., University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion

August 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 16, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-0378-E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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