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Emotion Regulation Group Therapy for Bipolar Disorder

Primary Purpose

Bipolar I Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhancing Emotion Regulation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar I Disorder focused on measuring bipolar disorder, depression, mania, emotion regulation, dialectical behavior therapy, group therapy, mindfulness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bipolar Clinic and Research Program

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enchancing Emotion Regulation

Arm Description

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

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale

Secondary Outcome Measures

Full Information

First Posted
September 7, 2010
Last Updated
April 9, 2015
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01207505
Brief Title
Emotion Regulation Group Therapy for Bipolar Disorder
Official Title
Emotion Regulation Group Therapy for Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Disorder
Keywords
bipolar disorder, depression, mania, emotion regulation, dialectical behavior therapy, group therapy, mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enchancing Emotion Regulation
Arm Type
Experimental
Arm Description
12 week group 3 week modules: 1) Mindfulness 2) Emotion Regulation 3) Distress Tolerance
Intervention Type
Behavioral
Intervention Name(s)
Enhancing Emotion Regulation
Intervention Description
12 week of group therapy 3 modules: 1) mindfulness, 2) emotion regulation, 3)distress tolerance
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thilo Deckersbach, Ph.D.
Organizational Affiliation
Bipolar Clinic and Research Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bipolar Clinic and Research Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Emotion Regulation Group Therapy for Bipolar Disorder

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