Pilot Study: Mindfulness-Based Cognitive Therapy as a Too... | NCT00999765

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

NCT00999765

Sponsor

Douglas Mental Health University Institute

Status

Completed

Last Update Posted

May 15, 2023Actual

Enrollment

36Actual

Phase

Not provided

Conditions

Bipolar Disorder

Interventions

Mindfulness-Based Cognitive Therapy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Dec 2012Actual

First Submitted Date

Oct 21, 2009

First Submission Date that Met QC Criteria

Oct 21, 2009

First Posted Date

Oct 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2023

Last Update Posted Date

May 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bipolar Disorder - stable			Behavioral: Mindfulness-Based Cognitive Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness-Based Cognitive Therapy	Behavioral	eight-week (two hours a week) group therapy (8-12 patients per group)	Bipolar Disorder - stable

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale		2, 4, 6, 8 and 12 weeks
Change in intensity of subsyndromal symptoms of depression on the MADRS scale		2, 4, 6, 8 and 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Bipolar Disorder of third-line bipolar disorders program

Sampling Method

Non-Probability Sample

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D064866	Mindfulness
D015928	Cognitive Behavioral Therapy
D001521	Behavior Therapy
D011613	Psychotherapy