Comparing Two Group Therapy Treatments for Binge Eating Disorder

June 26, 2013 updated by: Debra L. Safer, Stanford University

Comparison of Dialectical Behavior Therapy and Supportive Therapy for Binge Eating Disorder

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-5722
        • Stanford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Group therapy Negative Emotion Focus
Behavioral: Group Psychotherapy-Negative Emotion Focus
20 weekly sessions, 2 hours, group format
Placebo Comparator: 2
Group Psychotherapy- Self Esteem Focus
Behavioral: Group Psychotherapy- Self-Esteem Focus
20 weekly sessions, 2 hours, group format

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
frequency of binge eating
Time Frame: prior 4 weeks
prior 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Emotional Eating Scale
Time Frame: prior 7 days
prior 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Debra L Safer, MD, Stanford University Dept of Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

October 29, 2003

First Submitted That Met QC Criteria

October 29, 2003

First Posted (Estimate)

October 30, 2003

Study Record Updates

Last Update Posted (Estimate)

June 27, 2013

Last Update Submitted That Met QC Criteria

June 26, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23MH066330 (U.S. NIH Grant/Contract)
  • DSIR 8K-RTAT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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