Clinical trial NCT01126827: Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder
Official title: Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder: A Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Mood Disorders
Residual Symptoms
Depression
Mania
Hypomania
Bipolar
Bipolar I
Bipolar II
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-05-20
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

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 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.

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D) & Young Mania Rating Scale (YMRS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Bipolar Clinic and Research Program
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Thilo Deckersbach, PhD
role: PRINCIPAL_INVESTIGATOR
References: