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Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by University Health Network, Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188838
First received: September 12, 2005
Last updated: NA
Last verified: July 2005
History: No changes posted
  Purpose

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.

Condition Intervention
Bipolar Disorder
 Behavioral: Psychoeduction
Behavioral: Cognitive-Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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:
  • Clinician Administered Rating Scale for Mania
  • Hamilton Depression Rating Scale
  • 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

Estimated Enrollment: 210
Study Start Date: July 2002
Estimated Study Completion Date: August 2006
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)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188838

Locations
Canada, British Columbia
University of British Columbia, Department of Psychiatry
Vancouver, British Columbia, Canada, V6T-2A1
Canada, Ontario
St. Joseph's Healthcare, CMHS
Hamilton, Ontario, Canada, L8N-3K7
University Health Network
Toronto, Ontario, Canada, M5T-2S8
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T-1R8
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3G-1A4
Douglas Hospital-McGill University
Verdun, Quebec, Canada, H4G-1E2
Sponsors and Collaborators
University Health Network, Toronto
Stanley Medical Research Institute
Investigators
Principal Investigator: Sagar V Parikh, M.D. University Health Network, Toronto
  More Information

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00188838     History of Changes
Other Study ID Numbers: 02-0378-E
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Bipolar Disorder
Psychosocial Factors
Mania
 Depression
Social Adjustment
Coping Skills

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013