Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mindfulness Based Cognitive Therapy for Bipolar Disorder

NCT03507647

Bipolar Disorder

COMPLETED NA

"Mindfulness vs Psychoeducation in Bipolar Disorder"

NCT02133170

Bipolar Depressive Symptoms

UNKNOWN NA

Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder

NCT00999765

Bipolar Disorder

COMPLETED

Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder

NCT01176825

Bipolar Disorder

COMPLETED PHASE1

Mindfulness Psychoeducation for Bipolar Disorder

NCT07297056

Bipolar Disorder (BD) Mindfulness-Based Stress Reduction Mindfulness Meditation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supportive Psychotherapy

Group Type ACTIVE_COMPARATOR

Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy

Intervention Type BEHAVIORAL

12 weekly group therapy sessions

Mindfulness-Based Cognitive Behavioral Therapy

Group Type ACTIVE_COMPARATOR

Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy

Intervention Type BEHAVIORAL

12 weekly group therapy sessions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy

12 weekly group therapy sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No