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

NCT00999765 | Completed

• 1 other identifier: BD-MBCT
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Bipolar Depression; Mindfulness-Based Cognitive Therapy; MBCT; Maintenance; Euthymic; Efficacy; Feasibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Bipolar Disorder - stable

Behavioral: Mindfulness-Based Cognitive Therapy

Interventions

Mindfulness-Based Cognitive Therapy BEHAVIORAL

eight-week (two hours a week) group therapy (8-12 patients per group)

Bipolar Disorder - stable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bipolar Disorder of third-line bipolar disorders program

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Serge Beaulieu, Ph.D.

  Douglas Mental Health University Institute / McGill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Serge Beaulieu

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 22, 2009
• Study Start: June 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2012
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

CA (1)