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Status unknownNCT00188838Updated Sep 16, 2005

Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder

An interventional study of Psychoeduction and Cognitive-Behavioral Therapy in Bipolar Disorder, sponsored by University Health Network, Toronto. Status unknown at 6 sites in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2005-09-16.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2005), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.
Read the 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)

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Conditions studied

  • Bipolar Disorder

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Keywords

  • Bipolar Disorder
  • Psychosocial Factors
  • Mania
  • Depression
  • Social Adjustment
  • Coping Skills
03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 210 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
210 participants

Interventions

  • BehavioralPsychoeduction
  • BehavioralCognitive-Behavioral Therapy
06

What researchers measure

Primary outcomes

  1. Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).

  2. Modified Social Adjustment Scale (SAS II-B; Bauer, 2001)

  3. ***Note: all primary outcomes obtained prospectively every 3 months for 18 months

Secondary outcomes

  1. Clinician Administered Rating Scale for Mania

  2. Hamilton Depression Rating Scale

  3. Quality of Life, Enjoyment, and Satisfaction Questionnaire

  4. Dysfunctional Attitudes Scale

  5. Patient Satisfaction Index

  6. Activity and Utilisation Questionnaire

  7. Medication Compliance scale

  8. Intensity of Somatotherapy Index

  9. Coping Inventory for Prodromes of Mania

  10. Khavari Alcohol Test.

  11. *****Note: all secondary outcomes measured prospectively over 18 months

07

Study locations

6 sites
  • University of British Columbia, Department of Psychiatry
    Vancouver, British Columbia V6T-2A1, Canada
  • St. Joseph's Healthcare, CMHS
    Hamilton, Ontario L8N-3K7, Canada
  • Centre for Addiction and Mental Health
    Toronto, Ontario M5T-1R8, Canada
  • University Health Network
    Toronto, Ontario M5T-2S8, Canada
  • McGill University Health Centre
    Montreal, Quebec H3G-1A4, Canada
  • Douglas Hospital-McGill University
    Verdun, Quebec H4G-1E2, Canada
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References and documents

Publications

  • 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. PubMed 25046246 ↗
  • 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. PubMed 23972110 ↗
  • 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. PubMed 22795205 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00188838
Lead sponsor
University Health Network, Toronto
Collaborators
Stanley Medical Research Institute
First posted
Sep 16, 2005
Start date
Jul 2002
Completion
Aug 2006
Last update
Sep 16, 2005

Study contacts

Sagar V Parikh, M.D.
principal investigator · University Health Network, Toronto
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2005. You cannot join it, but the record below documents what was studied.

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