Clinical trial NCT00999765: Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder
Official title: Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Bipolar Depression
Mindfulness-Based Cognitive Therapy
MBCT
Maintenance
Euthymic
Efficacy
Feasibility
Lead sponsor: Douglas Mental Health University Institute
Sponsor class: OTHER
First posted: 2009-10-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bipolar Disorder of third-line bipolar disorders program

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.


Eligibility 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

Primary outcomes:
measure: number of weeks in which criteria are meet for a mood episode evaluate with the Longitudinal Interval Follow-up Evaluation (LIFE)
timeFrame: 12 weeks (4 weeks post treatment)
Secondary outcomes:
measure: Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale
timeFrame: 2, 4, 6, 8 and 12 weeks
measure: Change in intensity of subsyndromal symptoms of depression on the MADRS scale
timeFrame: 2, 4, 6, 8 and 12 weeks
measure: Change in intensity of subsyndromal symptoms of hypomania on the YMRS scale
timeFrame: 2, 4, 6, 8 and 12 weeks
measure: Change id intensity in subsyndromal symptoms of anxiety on the HAM-A scale
timeFrame: 2,4,6,8 and 12 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
affiliation: Douglas Mental Health University Institute / McGill
name: Serge Beaulieu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: