Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder
This study is ongoing, but not recruiting participants.
Sponsor:
Douglas Mental Health University Institute
Information provided by (Responsible Party):
Serge Beaulieu, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier:
NCT00999765
First received: October 21, 2009
Last updated: January 30, 2012
Last verified: January 2012
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Purpose
The purpose of this study is to evaluate the feasibility and short-term efficacy of MBCT as an add-on (i.e. patients must be stable with their regular mood stabilizing medication) for the maintenance therapy of bipolar disorder.
| Condition | Intervention |
|---|---|
|
Bipolar Disorder |
Behavioral: Mindfulness-Based Cognitive Therapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder |
Resource links provided by NLM:
Further study details as provided by Douglas Mental Health University Institute:
Primary Outcome Measures:
- number of weeks in which criteria are meet for a mood episode evaluate with the Longitudinal Interval Follow-up Evaluation (LIFE) [ Time Frame: 12 weeks (4 weeks post treatment) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale [ Time Frame: 2, 4, 6, 8 and 12 weeks ] [ Designated as safety issue: No ]
- Change in intensity of subsyndromal symptoms of depression on the MADRS scale [ Time Frame: 2, 4, 6, 8 and 12 weeks ] [ Designated as safety issue: No ]
- Change in intensity of subsyndromal symptoms of hypomania on the YMRS scale [ Time Frame: 2, 4, 6, 8 and 12 weeks ] [ Designated as safety issue: No ]
- Change id intensity in subsyndromal symptoms of anxiety on the HAM-A scale [ Time Frame: 2,4,6,8 and 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Bipolar Disorder - stable |
Behavioral: Mindfulness-Based Cognitive Therapy
eight-week (two hours a week) group therapy (8-12 patients per group)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Bipolar Disorder of third-line bipolar disorders program
Criteria
Inclusion Criteria:
- Males or females (>18 years old)
- Bipolar disorder (as per the Structured Clinical Interview for DSM Disorders (SCID)(22)), euthymic state: Complete remission for at least four weeks ((Montgomery and Asberg Rating Scale (MADRS) ≤ 6 and item-1 (depressed mood) = 0 and no suicidal ideations (MADRS(item-10) < 4)
- Must have had at least 3 depressive phases in the last 5 years
- Cooperative and willing to complete all the aspects of the study and especially the 45 minutes of exercise per day
- Must have completed a Secondary V (11th grade) education
Exclusion Criteria:
- Other active psychiatric disorders (as per the SCID)
- Rapid cycling
- Bipolar disorder secondary to a medical condition or substance-induced mood disorder
- Suicidal ideations (MADRS(item 10)>3)
- Active i.e. unstable and/or untreated medical condition
- Substance abuse (defined as per DSM-IV) in the last four weeks
- CBT (No more than four sessions (ever))
- Previous participation in a psychoeducation group within the last 6 months
- Current other psychotherapy (more than once a month)
- Practice of meditation (more than once a month) during the last two years
- Practice of yoga (more than once a week) during the last year
- Previous participation in a MBSR group
- Electroconvulsive Therapy (ECT) within the last three months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999765
Locations
| Canada, Quebec | |
| Douglas Mental Health University Institute | |
| Montréal, Quebec, Canada, H4H 1R3 | |
Sponsors and Collaborators
Douglas Mental Health University Institute
Investigators
| Principal Investigator: | Serge Beaulieu, Ph.D. | Douglas Mental Health University Institute / McGill |
More Information
No publications provided
| Responsible Party: | Serge Beaulieu, Douglas Mental Health University Institute |
| ClinicalTrials.gov Identifier: | NCT00999765 History of Changes |
| Other Study ID Numbers: | BD-MBCT |
| Study First Received: | October 21, 2009 |
| Last Updated: | January 30, 2012 |
| Health Authority: | Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by Douglas Mental Health University Institute:
|
Bipolar Disorder Bipolar Depression Mindfulness-Based Cognitive Therapy MBCT |
Maintenance Euthymic Efficacy Feasibility |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013