Emotion Regulation Group Therapy for Bipolar Disorder

NCT ID: NCT01207505

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-12-31

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.

Conditions

Bipolar I Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enchancing Emotion Regulation

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

Group Type: EXPERIMENTAL

Enhancing Emotion Regulation

Intervention Type: BEHAVIORAL

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

Interventions

Enhancing Emotion Regulation

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Thilo Deckersbach

Director of Psychology, Bipolar Clinic and Research Program Associate Professor of Psychology, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thilo Deckersbach, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Bipolar Clinic and Research Program

Locations

Bipolar Clinic and Research Program

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2010-P-001083

Identifier Type: -

Identifier Source: org_study_id