Bipolar DisorderNCT00188838
Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
A study testing Psychoeduction and Cognitive-Behavioral Therapy in people with Bipolar Disorder, run by University Health Network, Toronto at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Psychoeduction and Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 210 participants
- Where
- 6 sitesCanada
- Study dates
- Jul 2002to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
St. Joseph's Healthcare, CMHS
Hamilton, Ontario, L8N-3K7
McGill University Health Centre
Montreal, Quebec, H3G-1A4
Centre for Addiction and Mental Health
Toronto, Ontario, M5T-1R8
University Health Network
Toronto, Ontario, M5T-2S8
University of British Columbia, Department of Psychiatry
Vancouver, British Columbia, V6T-2A1
Douglas Hospital-McGill University
Verdun, Quebec, H4G-1E2
About this study
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.
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)
- Conditions
- Bipolar Disorder
- Being tested
- Psychoeduction, Cognitive-Behavioral Therapy
- Keywords
- Bipolar Disorder, Psychosocial Factors, Mania, Depression, Social Adjustment, Coping Skills
- Medical subject headings
- Bipolar Disorder, Mania, Depression, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeductionBehavioural
Cognitive-Behavioral TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2002
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Investigators
- Sagar V Parikh, M.D., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188838
- Sponsor's protocol ID
- 02-0378-E
- Status last verified
- Jul 2005
- First submitted
- 12 Sep 2005
- Last updated
- 16 Sep 2005
- Results posted
- No
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 25046246Parikh 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 23972110Parikh 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00188838
- Acronym / sponsor ID
- 02-0378-E
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Psychosocial Factors, Mania, Depression, Social Adjustment, Coping Skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Jul 2002
- Study completion
- Aug 2006
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeduction | Behavioural | – |
| Cognitive-Behavioral Therapy | Behavioural | – |
Primary outcome
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
11 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2005.
- Derived from this study: PubMed 25046246Parikh 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.
- Derived from this study: PubMed 23972110Parikh 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.
- Derived from this study: PubMed 22795205Parikh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sagar V Parikh, M.D. principal investigator
University Health Network, Toronto
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeduction and Cognitive-Behavioral Therapy in people with Bipolar Disorder, run by University Health Network, Toronto at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00188838, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2005.