Emotion Regulation Group Therapy for Bipolar Disorder

This study is currently recruiting participants.

Verified April 2012 by Massachusetts General Hospital

Sponsor:

Information provided by (Responsible Party):

Thilo Deckersbach, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01207505

First received: September 7, 2010

Last updated: April 25, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2010

Last Updated Date

April 25, 2012

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01207505 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Emotion Regulation Group Therapy for Bipolar Disorder

Official Title ^ICMJE

Emotion Regulation Group Therapy for Bipolar Disorder

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Bipolar I Disorder

Intervention ^ICMJE

Behavioral: Enhancing Emotion Regulation

12 week of group therapy 3 modules: 1) mindfulness, 2) emotion regulation, 3)distress tolerance

Study Arm (s)

Experimental: Enchancing Emotion Regulation

12 week group 3 week modules: 1) Mindfulness 2) Emotion Regulation 3) Distress Tolerance

Intervention: Behavioral: Enhancing Emotion Regulation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

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 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.
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.
Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Lori Eisner, Ph.D.	617-726-5258	leisner@partners.org
Contact: Thilo Deckersbach, Ph.D.	617-724-6300 ext 111-134-0183	tdeckersbach@partners.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01207505

Other Study ID Numbers ^ICMJE

2010-P-001083

Has Data Monitoring Committee

Responsible Party

Thilo Deckersbach, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thilo Deckersbach, Ph.D.

Bipolar Clinic and Research Program

Information Provided By

Massachusetts General Hospital

Verification Date

April 2012

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

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