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

This study is ongoing, but not recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 21, 2009

Last Updated Date

January 30, 2012

Start Date ^ICMJE

June 2008

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00999765 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Bipolar Disorder of third-line bipolar disorders program

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Behavioral: Mindfulness-Based Cognitive Therapy

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

Study Group/Cohort (s)

Bipolar Disorder - stable

Intervention: Behavioral: Mindfulness-Based Cognitive Therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00999765

Other Study ID Numbers ^ICMJE

BD-MBCT

Has Data Monitoring Committee

Responsible Party

Serge Beaulieu, Douglas Mental Health University Institute

Study Sponsor ^ICMJE

Douglas Mental Health University Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Serge Beaulieu, Ph.D.

Douglas Mental Health University Institute / McGill

Information Provided By

Douglas Mental Health University Institute

Verification Date

January 2012

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

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