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CompletedNCT00999765Updated May 15, 2023

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

An observational study in Bipolar Disorder, sponsored by Douglas Mental Health University Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-15.

Sponsored by Douglas Mental Health University Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
36
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Bipolar Disorder

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Keywords

  • Bipolar Disorder
  • Bipolar Depression
  • Mindfulness-Based Cognitive Therapy
  • MBCT
  • Maintenance
  • Euthymic
  • Efficacy
  • Feasibility
03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 36 is below the median of 160 across 329 observational studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

Douglas Mental Health University Institute is the lead sponsor of 38 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Bipolar Disorder of third-line bipolar disorders program

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
36 participants (actual)

Groups and cohorts

  • Bipolar Disorder - stable

    Behavioral: Mindfulness-Based Cognitive Therapy

Interventions

  • BehavioralMindfulness-Based Cognitive Therapy

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

06

What researchers measure

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

07

Study locations

1 site
  • Douglas Mental Health University Institute
    Montréal, Quebec H4H 1R3, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00999765
Lead sponsor
Douglas Mental Health University Institute
Responsible party
Serge Beaulieu (Serge Beaulieu, Douglas Mental Health University Institute) — Principal investigator
First posted
Oct 22, 2009
Start date
Jun 2008
Primary completion
Mar 2010
Completion
Dec 2012
Last update
May 15, 2023

Study contacts

Serge Beaulieu, Ph.D.
principal investigator · Douglas Mental Health University Institute / McGill

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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