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

Brief Summary

Official Title: “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.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: March 2010

Interventions Used in this Clinical Trial

  • Behavioral: Mindfulness-Based Cognitive Therapy
    • eight-week (two hours a week) group therapy (8-12 patients per group)

Arms, Groups and Cohorts in this Clinical Trial

  • Bipolar Disorder – stable

Outcome Measures for this Clinical Trial

Primary 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)
      Safety Issue?: No

Secondary Measures

  • Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale
    • Time Frame: 2, 4, 6, 8 and 12 weeks
      Safety Issue?: No
  • Change in intensity of subsyndromal symptoms of depression on the MADRS scale
    • Time Frame: 2, 4, 6, 8 and 12 weeks
      Safety Issue?: No
  • Change in intensity of subsyndromal symptoms of hypomania on the YMRS scale
    • Time Frame: 2, 4, 6, 8 and 12 weeks
      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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Douglas Mental Health University Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Serge Beaulieu, Serge Beaulieu – Douglas Mental Health University Institute
  • Overall Official(s)
    • Serge Beaulieu, Ph.D., Principal Investigator, Douglas Mental Health University Institute / McGill

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00999765