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

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01126827
First received: April 30, 2010
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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

  1. state of the art group MBCT, or
  2. supportive group psychotherapy (which is considered part of the standard care available to patients at MGH).

Condition Intervention
Bipolar Disorder
Behavioral: Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder: A Randomized, Controlled Study

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression (HAM-D) & Young Mania Rating Scale (YMRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 46
Study Start Date: January 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Supportive Psychotherapy Behavioral: Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy
12 weekly group therapy sessions
Active Comparator: Mindfulness-Based Cognitive Behavioral Therapy Behavioral: Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy
12 weekly group therapy sessions

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126827

Locations
United States, Massachusetts
Bipolar Clinic and Research Program
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Thilo Deckersbach, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Thilo Deckersbach, PhD/Assistant Professor of Psychology, Harvard Medical School; Director, Cognitive Neuroscience Research, Bipolar Clinic and Research Program, Massachusetts General Hospital, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01126827     History of Changes
Other Study ID Numbers: MBCT Randomized Study
Study First Received: April 30, 2010
Last Updated: July 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Bipolar Disorder
Mood Disorders
Residual Symptoms
Depression
Mania
Hypomania
Bipolar
Bipolar I
Bipolar II

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014