Emotion Regulation Group Therapy for Bipolar Disorder

Not Applicable

Completed

• Conditions: Bipolar I Disorder
• Interventions: Behavioral: Enhancing Emotion Regulation

• Registration Number: NCT01207505
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-23
• Primary Completion: 2013-03
• Study Completion: 2013-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enchancing Emotion Regulation	Enhancing Emotion Regulation	12 week group 3 week modules: 1) Mindfulness 2) Emotion Regulation 3) Distress Tolerance

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	Up to 24 weeks

Trial Locations

Locations (1)

Bipolar Clinic and Research Program; 🇺🇸 Boston, Massachusetts, United States