Effectiveness of Binge Eating Disorder Treatments

May 14, 2014 updated by: Stanford University

Effectiveness of Psychological Treatments for BED

This study will evaluate the long-term effectiveness of interpersonal psychotherapy, behavioral weight loss interventions, and guided self help treatments in treating binge eating disorder (BED).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BED is a serious condition that is associated with psychiatric comorbidity, psychosocial impairment, and obesity. Interpersonal psychotherapy (IPT), behavioral weight loss (BWL) interventions, and guided self help (GSH) treatments for BED have been evaluated, but the safest and most effective treatment has not yet been identified. This study will determine which of these three treatments is most effective in treating BED.

Participants are stratified by negative affect subtype and are randomly assigned for 6 months to one of three treatment groups: IPT, BWL, or GSH. IPT focuses on current interpersonal problems which are hypothesized to increase negative affect and lead to binge eating. BWL interventions involve the adoption of weight loss inducing behaviors. GSH is a shortened version of cognitive behavioral therapy that focuses directly on eating behavior. IPT and BWL patients have 20 treatment sessions; those receiving GSH have 10 sessions. Assessments are made pre-treatment, post-treatment, and at 6, 12, 18, and 24 months after treatment is complete.

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 4

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
        • W. Stewart Agras
    • Missouri
      • St. Louis, Missouri, United States, 63100
        • Washington University School of Medicine
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Rutgers University Eating Disorder Clinic

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV criteria for Binge Eating Disorder
  • Body Mass Index (BMI) between 27 and 45

Exclusion criteria:

  • Body Mass index > 45
  • Current psychosis
  • Current bipolar disorder
  • Alcohol or drug dependence within last 6-months

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: Interpersonal Therapy
Interpersonal Therapy is a psychotherapy aimed at resolving interpersonal difficulties
Behavioral: Interpersonal Therapy
20 sessions of interpersonal therapy were provided over a 6-month period
Other Names:
  • IPT
Active Comparator: Behavioral Weight Loss Treatment
Behavioral Weight Loss Treatment is aimed solely at weight loss, however it has been shown to decrease binge eating
Behavioral: Behavioral Weight Loss Treatment
20 sessions of behavioral weight loss treatment were provided over a 6-month period
Other Names:
  • BWL; Weight loss treatment
Active Comparator: Guided Self Help
Guided Self-Help is a brief psychotherapy based on cognitive-behavioral treatment
Behavioral: Guided Self Help
10 sessions of guided self help were provided over a 6-month period
Other Names:
  • GSH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binge eating
Time Frame: Pre-treatment, 6, 12, and 24-months
Rate of binge eating
Pre-treatment, 6, 12, and 24-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating disorder psychopathology
Time Frame: pre-treatment, 6, 12, 24 months
Assessed by the Eating Disorder Examination
pre-treatment, 6, 12, 24 months

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

  • Study Director: William S Agras, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2002

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

May 12, 2003

First Submitted That Met QC Criteria

May 12, 2003

First Posted (Estimate)

May 13, 2003

Study Record Updates

Last Update Posted (Estimate)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH063863 (U.S. NIH Grant/Contract)
  • DSIR 83-ATAS (NIMH Program Class Code)

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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