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

September 7, 2010
September 23, 2010
April 10, 2015
July 2010
March 2013   (Final data collection date for primary outcome measure)
Hamilton Depression Rating Scale [ Time Frame: Up to 24 weeks ]
Same as current
Complete list of historical versions of study NCT01207505 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Emotion Regulation Group Therapy for Bipolar Disorder
Emotion Regulation Group Therapy for Bipolar Disorder
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.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bipolar I Disorder
Behavioral: Enhancing Emotion Regulation
12 week of group therapy 3 modules: 1) mindfulness, 2) emotion regulation, 3)distress tolerance
Experimental: Enchancing Emotion Regulation
12 week group 3 week modules: 1) Mindfulness 2) Emotion Regulation 3) Distress Tolerance
Intervention: Behavioral: Enhancing Emotion Regulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2013
March 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Thilo Deckersbach, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Thilo Deckersbach, Ph.D. Bipolar Clinic and Research Program
Massachusetts General Hospital
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP