Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder (MBCT)
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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
- state of the art group MBCT, or
- 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 |
- 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 |
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| United States, Massachusetts | |
| Bipolar Clinic and Research Program | |
| Boston, Massachusetts, United States, 02114 | |
| 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 May 16, 2013