Emotion Regulation Group Therapy for Bipolar Disorder
This study is currently recruiting participants.
Verified April 2012 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
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
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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: | June 2013 |
| Estimated Primary Completion Date: | June 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:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207505
Contacts
| 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 |
Locations
| United States, Massachusetts | |
| Bipolar Clinic and Research Program | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Lori R Eisner, Ph.D. 617-726-5258 leisner@partners.org | |
| Contact: Thilo Deckersbach, Ph.D. 617-724-6300 ext 111-134-0183 tdeckersbach@partners.org | |
| Sub-Investigator: Lori Eisner, Ph.D. | |
| Principal Investigator: Thilo Deckersbach, Ph.D. | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Thilo Deckersbach, Ph.D. | Bipolar Clinic and Research Program |
More Information
Additional 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: | April 25, 2012 |
| 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 May 19, 2013