Emotion Regulation Group Therapy for Bipolar Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Emotion Regulation Group Therapy for Bipolar Disorder

Conditions
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Bipolar I Disorder

Intervention / Treatment
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* Behavioral: Enhancing Emotion Regulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enchancing Emotion Regulation<br>12 week group 3 week modules: 1) Mindfulness 2) Emotion Regulation 3) Distress Tolerance | Behavioral: Enhancing Emotion Regulation<br>* 12 week of group therapy 3 modules: 1) mindfulness, 2) emotion regulation, 3)distress tolerance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale |  | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar disorder, depression, mania, emotion regulation, dialectical behavior therapy, group therapy, mindfulness