Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Behavioral: Psychoeduction
* Behavioral: Cognitive-Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Psychoeduction|nan|
|Behavioral: Cognitive-Behavioral Therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorder, Psychosocial Factors, Mania, Depression, Social Adjustment, Coping Skills