Emotion Regulation Group Therapy for Bipolar Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thilo Deckersbach, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01207505
First received: September 7, 2010
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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 Intervention
Bipolar I Disorder
Behavioral: Enhancing Emotion Regulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Emotion Regulation Group Therapy for Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207505

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

No publications provided

Responsible Party: Thilo Deckersbach, Director of Psychology, Bipolar Clinic and Research Program Associate Professor of Psychology, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01207505     History of Changes
Other Study ID Numbers: 2010-P-001083
Study First Received: September 7, 2010
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
bipolar disorder
depression
mania
emotion regulation
dialectical behavior therapy
group therapy
mindfulness

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014