search
Back to results

Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Psychoeduction
Cognitive-Behavioral Therapy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Psychosocial Factors, Mania, Depression, Social Adjustment, Coping Skills

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of British Columbia, Department of Psychiatry
  • St. Joseph's Healthcare, CMHS
  • Centre for Addiction and Mental Health
  • University Health Network
  • McGill University Health Centre
  • Douglas Hospital-McGill University

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
University Health Network, Toronto
Collaborators
Stanley Medical Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00188838
Brief Title
Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
Official Title
Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Stanley Medical Research Institute

4. Oversight

5. 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.
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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Disorder, Psychosocial Factors, Mania, Depression, Social Adjustment, Coping Skills

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sagar V Parikh, M.D.
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia, Department of Psychiatry
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T-2A1
Country
Canada
Facility Name
St. Joseph's Healthcare, CMHS
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N-3K7
Country
Canada
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T-1R8
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T-2S8
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G-1A4
Country
Canada
Facility Name
Douglas Hospital-McGill University
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4G-1E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25046246
Citation
Parikh SV, Hawke LD, Velyvis V, Zaretsky A, Beaulieu S, Patelis-Siotis I, MacQueen G, Young LT, Yatham LN, Cervantes P. Combined treatment: impact of optimal psychotherapy and medication in bipolar disorder. Bipolar Disord. 2015 Feb;17(1):86-96. doi: 10.1111/bdi.12233. Epub 2014 Jul 21.
Results Reference
derived
PubMed Identifier
23972110
Citation
Parikh SV, Hawke LD, Zaretsky A, Beaulieu S, Patelis-Siotis I, Macqueen G, Young LT, Yatham L, Velyvis V, Belanger C, Poirier N, Enright J, Cervantes P. Psychosocial interventions for bipolar disorder and coping style modification: similar clinical outcomes, similar mechanisms? Can J Psychiatry. 2013 Aug;58(8):482-6. doi: 10.1177/070674371305800807.
Results Reference
derived
PubMed Identifier
22795205
Citation
Parikh SV, Zaretsky A, Beaulieu S, Yatham LN, Young LT, Patelis-Siotis I, Macqueen GM, Levitt A, Arenovich T, Cervantes P, Velyvis V, Kennedy SH, Streiner DL. A randomized controlled trial of psychoeducation or cognitive-behavioral therapy in bipolar disorder: a Canadian Network for Mood and Anxiety treatments (CANMAT) study [CME]. J Clin Psychiatry. 2012 Jun;73(6):803-10. doi: 10.4088/JCP.11m07343.
Results Reference
derived

Learn more about this trial

Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

We'll reach out to this number within 24 hrs