Emotion Regulation Group Therapy for Bipolar Disorder | NCT01207505

Studies
Emotion Regulation Group Therapy for Bipolar Disorder

NCT01207505

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Apr 10, 2015Estimated

Enrollment

38Actual

Phase

Not Applicable

Conditions

Bipolar I Disorder

Interventions

Enhancing Emotion Regulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Mar 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Sep 7, 2010

First Submission Date that Met QC Criteria

Sep 21, 2010

First Posted Date

Sep 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2015

Last Update Posted Date

Apr 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enchancing Emotion Regulation	Experimental	12 week group 3 week modules: 1) Mindfulness 2) Emotion Regulation 3) Distress Tolerance	Behavioral: Enhancing Emotion Regulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enhancing Emotion Regulation	Behavioral	12 week of group therapy 3 modules: 1) mindfulness, 2) emotion regulation, 3)distress tolerance	Enchancing Emotion Regulation

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Thilo Deckersbach, Ph.D.	Bipolar Clinic and Research Program	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Bipolar Clinic and Research Program		Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder
D003863	Depression
D000087122	Mania
D000080103	Emotional Regulation

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

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Browse Branches

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