NCT00188838

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. 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. 2.Cognitive behavioural therapy will reduce social and occupational disability to a greater extent than psychoeducation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

September 16, 2005

Status Verified

July 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Bipolar Disorder

Keywords

Bipolar DisorderPsychosocial FactorsManiaDepressionSocial AdjustmentCoping Skills

Outcome Measures

Primary Outcomes (3)

  • 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 (11)

  • Clinician Administered Rating Scale for Mania

  • Hamilton Depression Rating Scale

  • Quality of Life, Enjoyment, and Satisfaction Questionnaire

  • Dysfunctional Attitudes Scale

  • Patient Satisfaction Index

  • +6 more secondary outcomes

Interventions

PsychoeductionBEHAVIORAL
Cognitive-Behavioral TherapyBEHAVIORAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of British Columbia, Department of Psychiatry

Vancouver, British Columbia, V6T-2A1, Canada

Location

St. Joseph's Healthcare, CMHS

Hamilton, Ontario, L8N-3K7, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T-1R8, Canada

Location

University Health Network

Toronto, Ontario, M5T-2S8, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3G-1A4, Canada

Location

Douglas Hospital-McGill University

Verdun, Quebec, H4G-1E2, Canada

Location

Related Publications (3)

  • 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.

    PMID: 25046246DERIVED

  • 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.

    PMID: 23972110DERIVED

  • 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.

    PMID: 22795205DERIVED

MeSH Terms

Conditions

Bipolar DisorderManiaDepressionSocial Adjustment

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sagar V Parikh, M.D.

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

July 1, 2002

Study Completion

August 1, 2006

Last Updated

September 16, 2005

Record last verified: 2005-07

Locations

CA(6)