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

October 21, 2009
January 30, 2012
June 2008
March 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00999765 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder
Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Bipolar Disorder of third-line bipolar disorders program

Bipolar Disorder
Behavioral: Mindfulness-Based Cognitive Therapy
eight-week (two hours a week) group therapy (8-12 patients per group)
Bipolar Disorder - stable
Intervention: Behavioral: Mindfulness-Based Cognitive Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
December 2012
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00999765
BD-MBCT
No
Serge Beaulieu, Douglas Mental Health University Institute
Douglas Mental Health University Institute
Not Provided
Principal Investigator: Serge Beaulieu, Ph.D. Douglas Mental Health University Institute / McGill
Douglas Mental Health University Institute
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP