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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999765
• Other study ID #: BD-MBCT
• Status: Completed
• Start date: June 2008
• Est. completion date: December 2012

Study information

• Verified date: May 2023
• Source: Douglas Mental Health University Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2012
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

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

Locations

Country	Name	City	State
Canada	Douglas Mental Health University Institute	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of weeks in which criteria are meet for a mood episode evaluate with the Longitudinal Interval Follow-up Evaluation (LIFE)		12 weeks (4 weeks post treatment)
Secondary	Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale		2, 4, 6, 8 and 12 weeks
Secondary	Change in intensity of subsyndromal symptoms of depression on the MADRS scale		2, 4, 6, 8 and 12 weeks
Secondary	Change in intensity of subsyndromal symptoms of hypomania on the YMRS scale		2, 4, 6, 8 and 12 weeks
Secondary	Change id intensity in subsyndromal symptoms of anxiety on the HAM-A scale		2,4,6,8 and 12 weeks