Emotion Regulation Group Therapy for Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01207505
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : April 10, 2015
Information provided by (Responsible Party):
Thilo Deckersbach, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Behavioral: Enhancing Emotion Regulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Emotion Regulation Group Therapy for Bipolar Disorder
Study Start Date : July 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale [ Time Frame: Up to 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01207505

United States, Massachusetts
Bipolar Clinic and Research Program
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Thilo Deckersbach, Ph.D. Bipolar Clinic and Research Program

Responsible Party: Thilo Deckersbach, Director of Psychology, Bipolar Clinic and Research Program Associate Professor of Psychology, Harvard Medical School, Massachusetts General Hospital Identifier: NCT01207505     History of Changes
Other Study ID Numbers: 2010-P-001083
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Thilo Deckersbach, Massachusetts General Hospital:
bipolar disorder
emotion regulation
dialectical behavior therapy
group therapy

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders