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Completed

NCT Number: NCT00999765

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Cognitive Therapy

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale

    Time frame: 2, 4, 6, 8 and 12 weeks

  2. Change in intensity of subsyndromal symptoms of depression on the MADRS scale

    Time frame: 2, 4, 6, 8 and 12 weeks

  3. Change in intensity of subsyndromal symptoms of hypomania on the YMRS scale

    Time frame: 2, 4, 6, 8 and 12 weeks

  4. Change id intensity in subsyndromal symptoms of anxiety on the HAM-A scale

    Time frame: 2,4,6,8 and 12 weeks

Sponsors and collaborators

Lead sponsor

Douglas Mental Health University Institute

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Oct 22, 2009
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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