Clinical trial NCT00188838: Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
Official title: Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Psychosocial Factors
Mania
Depression
Social Adjustment
Coping Skills
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2005-09-16
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).
measure: Modified Social Adjustment Scale (SAS II-B; Bauer, 2001)
measure: ***Note: all primary outcomes obtained prospectively every 3 months for 18 months
Secondary outcomes:
measure: Clinician Administered Rating Scale for Mania
measure: Hamilton Depression Rating Scale
measure: Quality of Life, Enjoyment, and Satisfaction Questionnaire
measure: Dysfunctional Attitudes Scale
measure: Patient Satisfaction Index
measure: Activity and Utilisation Questionnaire
measure: Medication Compliance scale
measure: Intensity of Somatotherapy Index
measure: Coping Inventory for Prodromes of Mania
measure: Khavari Alcohol Test.
measure: *****Note: all secondary outcomes measured prospectively over 18 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia, Department of Psychiatry
state: British Columbia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare, CMHS
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Verdun
country: Canada
facility: Douglas Hospital-McGill University
state: Quebec
Study officials:
affiliation: University Health Network, Toronto
name: Sagar V Parikh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.