Overview

This trial is active, not recruiting.

Condition bipolar disorder
Treatments psychoeduction, cognitive-behavioral therapy
Sponsor University Health Network, Toronto
Collaborator Stanley Medical Research Institute
Start date July 2002
End date August 2006
Trial size 210 participants
Trial identifier NCT00188838, 02-0378-E

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).
time frame:
Modified Social Adjustment Scale (SAS II-B; Bauer, 2001)
time frame:
***Note: all primary outcomes obtained prospectively every 3 months for 18 months
time frame:

Secondary Outcomes

Measure
Clinician Administered Rating Scale for Mania
time frame:
Hamilton Depression Rating Scale
time frame:
Quality of Life, Enjoyment, and Satisfaction Questionnaire
time frame:
Dysfunctional Attitudes Scale
time frame:
Patient Satisfaction Index
time frame:
Activity and Utilisation Questionnaire
time frame:
Medication Compliance scale
time frame:
Intensity of Somatotherapy Index
time frame:
Coping Inventory for Prodromes of Mania
time frame:
Khavari Alcohol Test.
time frame:
*****Note: all secondary outcomes measured prospectively over 18 months
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

Official title Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
Principal investigator Sagar V Parikh, M.D.
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)
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.