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

Completed

• Conditions: Bipolar Disorder
• Interventions: Behavioral: Mindfulness-Based Cognitive Therapy

• Registration Number: NCT00999765
• Lead Sponsor: Douglas Mental Health University Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-21
• Study First Posted: 2009-10-22
• Primary Completion: 2010-03
• Study Completion: 2012-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bipolar Disorder - stable	Mindfulness-Based Cognitive Therapy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 hypomania on the YMRS 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 id intensity in subsyndromal symptoms of anxiety on the HAM-A scale	2,4,6,8 and 12 weeks

Trial Locations

Locations (1)

Douglas Mental Health University Institute; 🇨🇦 Montréal, Quebec, Canada