Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Behavioral: Mindfulness-Based Cognitive Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bipolar Disorder - stable<br> | Behavioral: Mindfulness-Based Cognitive Therapy<br>* eight-week (two hours a week) group therapy (8-12 patients per group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of weeks in which criteria are meet for a mood episode evaluate with the Longitudinal Interval Follow-up Evaluation (LIFE) |  | 12 weeks (4 weeks post treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale |  | 2, 4, 6, 8 and 12 weeks | 
| Change in intensity of subsyndromal symptoms of depression on the MADRS scale |  | 2, 4, 6, 8 and 12 weeks | 
| Change in intensity of subsyndromal symptoms of hypomania on the YMRS scale |  | 2, 4, 6, 8 and 12 weeks | 
| Change id intensity in subsyndromal symptoms of anxiety on the HAM-A scale |  | 2,4,6,8 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorder, Bipolar Depression, Mindfulness-Based Cognitive Therapy, MBCT, Maintenance, Euthymic, Efficacy, Feasibility