Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

University Health Network, Toronto210 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Bipolar Disorder

Interventions

PsychoeductionBEHAVIORAL

Cognitive-Behavioral TherapyBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (6)

University of British Columbia, Department of Psychiatry

Vancouver, British Columbia, Canada

St. Joseph's Healthcare, CMHS

Hamilton, Ontario, Canada

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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