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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Douglas Mental Health University Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Serge Beaulieu, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier:
NCT00999765
First received: October 21, 2009
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Bipolar Disorder
Behavioral: Mindfulness-Based Cognitive Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Douglas Mental Health University Institute:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale [ Time Frame: 2, 4, 6, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change in intensity of subsyndromal symptoms of depression on the MADRS scale [ Time Frame: 2, 4, 6, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change in intensity of subsyndromal symptoms of hypomania on the YMRS scale [ Time Frame: 2, 4, 6, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change id intensity in subsyndromal symptoms of anxiety on the HAM-A scale [ Time Frame: 2,4,6,8 and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: June 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bipolar Disorder - stable Behavioral: Mindfulness-Based Cognitive Therapy
eight-week (two hours a week) group therapy (8-12 patients per group)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Bipolar Disorder of third-line bipolar disorders program

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999765

Locations
Canada, Quebec
Douglas Mental Health University Institute
Montréal, Quebec, Canada, H4H 1R3
Sponsors and Collaborators
Douglas Mental Health University Institute
Investigators
Principal Investigator: Serge Beaulieu, Ph.D. Douglas Mental Health University Institute / McGill
  More Information

No publications provided

Responsible Party: Serge Beaulieu, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier: NCT00999765     History of Changes
Other Study ID Numbers: BD-MBCT
Study First Received: October 21, 2009
Last Updated: January 30, 2012
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Douglas Mental Health University Institute:
Bipolar Disorder
Bipolar Depression
Mindfulness-Based Cognitive Therapy
MBCT
Maintenance
Euthymic
Efficacy
Feasibility

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014