Comparing Two Group Therapy Treatments for Binge Eating Disorder

NCT ID: NCT00071578

Last Updated: 2013-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-07-31

Brief Summary

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This study will compare two different approaches for the treatment for Binge Eating Disorder.

Detailed Description

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Binge Eating Disorder (BED) is associated with impairments in physical, psychological, and social functioning. Research has revealed relationships between disordered eating and both low self-esteem and negative emotional states.

Participants in this study will complete assessment interviews regarding their eating disorder and associated problems. Similar assessments will be conducted at the end of the study. Participants will then be randomly assigned to one of two therapy groups. Participants in one group will focus on the role of self-esteem, self-awareness, and personal effectiveness in binge eating. Participants in the other group will focus on the role of negative emotions and binge eating. Both treatments will involve a 30 to 40 minute pre-treatment individual orientation session, followed by 20 weeks of weekly group therapy. Sessions will take place over 22 weeks, or approximately 6 months (18 weekly sessions followed by 2 biweekly sessions). Follow-up assessments will take place at 3 months, 6 months, and 12 months after study completion to assess maintenance of treatment effects.

Conditions

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Eating Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group therapy Negative Emotion Focus

Group Type EXPERIMENTAL

Group Psychotherapy-Negative Emotion Focus

Intervention Type BEHAVIORAL

20 weekly sessions, 2 hours, group format

2

Group Psychotherapy- Self Esteem Focus

Group Type PLACEBO_COMPARATOR

Group Psychotherapy- Self-Esteem Focus

Intervention Type BEHAVIORAL

20 weekly sessions, 2 hours, group format

Interventions

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Group Psychotherapy-Negative Emotion Focus

20 weekly sessions, 2 hours, group format

Intervention Type BEHAVIORAL

Group Psychotherapy- Self-Esteem Focus

20 weekly sessions, 2 hours, group format

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Binge Eating Disorder
* Reside in the San Francisco Bay Area
* Willing to commit to the study requirements

Exclusion Criteria

* Unstable medical problems
* History of bipolar illness or schizophrenia
* Receiving treatment for an eating disorder (or unwillingness to discontinue treatment upon study entry)
* Membership in weight-loss groups such as Weight Watchers or Jenny Craig (or unwillingness to discontinue membership upon study entry)
* Use of medications affecting weight or appetite. Antidepressants are acceptable, but doses of any psychiatric medication must have been stable for at least 3 months prior to study start
* Breast-feeding
* Require gastric-bypass surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Debra L. Safer

Asst professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Debra L Safer, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University Dept of Psychiatry

Locations

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Stanford University Medical Center

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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K23MH066330

Identifier Type: NIH

Identifier Source: org_study_id

View Link

K23MH066330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 8K-RTAT

Identifier Type: -

Identifier Source: secondary_id

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