Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

Sponsor

University Health Network, Toronto (Other)

Overall Status

Unknown status

CT.gov ID

NCT00188838

Collaborator

Stanley Medical Research Institute (Other)

210

Enrollment

Locations

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

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

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Behavioral: Psychoeduction Behavioral: Cognitive-Behavioral Therapy	N/A

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

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

Study Start Date :

Jul 1, 2002

Study Completion Date :

Aug 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Substance dependence meeting Diagnostic and Statistical Manual of Mental Disorders-IV criteria within the last three months.
Acutely highly suicidal or homicidal.
Serious other medical condition that would render pharmacotherapy or psychotherapy very difficult such as cancer, severe diabetes, etc.
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

Locations

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