This trial is active, not recruiting.

Condition bipolar disorder
Treatment mindfulness-based cognitive therapy
Sponsor Douglas Mental Health University Institute
Start date June 2008
End date March 2010
Trial size 36 participants
Trial identifier NCT00999765, BD-MBCT


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
mindfulness-based cognitive therapy
eight-week (two hours a week) group therapy (8-12 patients per group)

Primary Outcomes

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)

Secondary Outcomes

Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale
time frame: 2, 4, 6, 8 and 12 weeks
Change in intensity of subsyndromal symptoms of depression on the MADRS scale
time frame: 2, 4, 6, 8 and 12 weeks
Change in intensity of subsyndromal symptoms of hypomania on the YMRS scale
time frame: 2, 4, 6, 8 and 12 weeks
Change id intensity in subsyndromal symptoms of anxiety on the HAM-A scale
time frame: 2,4,6,8 and 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder
Principal investigator Serge Beaulieu, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Douglas Mental Health University Institute.