Emotion Regulation Group Therapy for Bipolar Disorder

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.

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Key information

Conditions

Bipolar I Disorder Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Emotional Regulation Mania Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Self-Control Signs and Symptoms Social Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bipolar Clinic and Research Program

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhancing Emotion Regulation

Behavioral

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

Primary outcomes

Hamilton Depression Rating Scale

Time frame: Up to 24 weeks

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Sep 23, 2010
Registry last updated: Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed