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Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder (MBCT)

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Mood Disorders, Residual Symptoms, Depression, Mania, Hypomania, Bipolar, Bipolar I, Bipolar II

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • MINI diagnostic criteria for any bipolar disorder (type I, type II, and NOS)
  • Written informed consent
  • Men or women aged 18-65
  • No episodes of mania in the previous 4 weeks.
  • Able to read and understand English.

Exclusion Criteria:

  • Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
  • History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc).
  • History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months.
  • Patients who have untreated hypothyroidism.
  • Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment.

Sites / Locations

  • Bipolar Clinic and Research Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Supportive Psychotherapy

Mindfulness-Based Cognitive Behavioral Therapy

Arm Description

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression (HAM-D) & Young Mania Rating Scale (YMRS)
HAM-D (depression severity) and YMRS (mania/hypomania severity) total scores will be evaluated as the primary outcome measures of mood symptoms of bipolar disorder as part of this trial.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2010
Last Updated
July 6, 2011
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01126827
Brief Title
Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder
Acronym
MBCT
Official Title
Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder: A Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to investigate the efficacy of mindfulness-based cognitive-behavior therapy (MBCT) for improvement of symptoms associated with bipolar disorder, by comparing MBCT to supportive psychotherapy. Patients who participate in this study will be randomly assigned to receive either state of the art group MBCT, or supportive group psychotherapy (which is considered part of the standard care available to patients at MGH).
Detailed Description
We will conduct a randomized controlled trial of group MBCT (n=30) vs. SP (n=30) and compare the benefits and durability of MBCT vs. SP for decreasing symptoms in DSM-IV bipolar individuals over a 12-week period adjunctive to mood stabilizing medications coupled with individual-therapy sessions. We will also conduct follow-up assessments at 3, 6, 9, and 12 months after the active phase of the study. Subjects in the MBCT group will receive group therapy sessions of standardized yoga-meditation based exercises enhanced by psychoeducation and relapse prevention for bipolar disorder. Subjects in the SP group will receive support for coping with the symptoms of bipolar disorder, as well as psychoeducation about bipolar disorder. The focus of SP is on reflecting and expressing feelings about current life issues. Patients are supported and comforted when coping with difficult situations, depression, mood swings, or anger. We will assess mood, cognitive and psychosocial functioning before and after treatment for participants in both groups. Finally, we will investigate the functional neuroanatomy associated with memory impairment, attention, and mindful breathing in subjects with bipolar disorder as a predictor of treatment response using functional Magnetic Resonance Imaging (fMRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Disorder, Mood Disorders, Residual Symptoms, Depression, Mania, Hypomania, Bipolar, Bipolar I, Bipolar II

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Psychotherapy
Arm Type
Active Comparator
Arm Title
Mindfulness-Based Cognitive Behavioral Therapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy
Intervention Description
12 weekly group therapy sessions
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAM-D) & Young Mania Rating Scale (YMRS)
Description
HAM-D (depression severity) and YMRS (mania/hypomania severity) total scores will be evaluated as the primary outcome measures of mood symptoms of bipolar disorder as part of this trial.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: MINI diagnostic criteria for any bipolar disorder (type I, type II, and NOS) Written informed consent Men or women aged 18-65 No episodes of mania in the previous 4 weeks. Able to read and understand English. Exclusion Criteria: Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment. History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc). History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months. Patients who have untreated hypothyroidism. Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thilo Deckersbach, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bipolar Clinic and Research Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.massgeneral.org/bipolar
Description
MGH Bipolar Clinic and Research Program

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Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder

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