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Clinical Trial 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

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).


Clinical Trial 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). ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01126827
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Completed
Phase N/A
Start date January 2010
Completion date April 2011

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