Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00188838
• Other study ID #: 02-0378-E
• Status: Active, not recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: July 2002
• Est. completion date: August 2006

Study information

• Verified date: July 2005
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Psychoeduction

• Cognitive-Behavioral Therapy

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare, CMHS	Hamilton	Ontario
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	University of British Columbia, Department of Psychiatry	Vancouver	British Columbia
Canada	Douglas Hospital-McGill University	Verdun	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Stanley Medical Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).
Primary	Modified Social Adjustment Scale (SAS II-B; Bauer, 2001)
Primary	***Note: all primary outcomes obtained prospectively every 3 months for 18 months
Secondary	Clinician Administered Rating Scale for Mania
Secondary	Hamilton Depression Rating Scale
Secondary	Quality of Life, Enjoyment, and Satisfaction Questionnaire
Secondary	Dysfunctional Attitudes Scale
Secondary	Patient Satisfaction Index
Secondary	Activity and Utilisation Questionnaire
Secondary	Medication Compliance scale
Secondary	Intensity of Somatotherapy Index
Secondary	Coping Inventory for Prodromes of Mania
Secondary	Khavari Alcohol Test.
Secondary	*****Note: all secondary outcomes measured prospectively over 18 months