Emotion Regulation Group Therapy for Bipolar Disorder

April 9, 2015 updated by: Thilo Deckersbach, Massachusetts General Hospital
Psychoeducation has been the only group treatment developed for bipolar disorder thus far. Deficits in emotion regulation, a core impairment among patients with bipolar disorder, are not directly addressed in this treatment. The objective of this study is to develop a group treatment for bipolar disorder that focuses on emotion regulation strategies (Enhancing Emotion Regulation; EER). This study will examine the efficacy of this treatment using an open trial design. It is hypothesized that patients who receive EER will show a reduction in mood symptoms and improvement in well-being. Reductions in emotion regulation difficulties will predict improvements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Bipolar Clinic and Research Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of bipolar I disorder.
  2. Able to provide written informed consent.
  3. Men or women aged 18-65.
  4. Able to read and understand English.
  5. Psychiatrist prescribing mood-stabilizing medication.
  6. Participates in bimonthly individual psychotherapy

Exclusion Criteria:

  1. Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
  2. 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).
  3. History or current diagnosis of the following Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (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.
  4. Patients who currently meet criteria for a major depressive episode, a manic episode, or a mixed episode. Excluded participants may remain on a waiting list to partake in a future group dependent on mood stabilization.
  5. Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enchancing Emotion Regulation
12 week group 3 week modules: 1) Mindfulness 2) Emotion Regulation 3) Distress Tolerance
Behavioral: Enhancing Emotion Regulation
12 week of group therapy 3 modules: 1) mindfulness, 2) emotion regulation, 3)distress tolerance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Rating Scale
Time Frame: Up to 24 weeks
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Thilo Deckersbach, Ph.D., Bipolar Clinic and Research Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 23, 2010

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-P-001083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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