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

May 12, 2023 updated by: Serge Beaulieu, Douglas Mental Health University Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4H 1R3
        • Douglas Mental Health University Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Bipolar Disorder of third-line bipolar disorders program

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bipolar Disorder - stable
Behavioral: Mindfulness-Based Cognitive Therapy
eight-week (two hours a week) group therapy (8-12 patients per group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
12 weeks (4 weeks post treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale
Time Frame: 2, 4, 6, 8 and 12 weeks
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
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
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
2,4,6,8 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Douglas Mental Health University Institute

Investigators

  • Principal Investigator: Serge Beaulieu, Ph.D., Douglas Mental Health University Institute / McGill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (Estimate)

October 22, 2009

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD-MBCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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