Guided Self-Help Treatment for Binge Eating Disorder (BEST)

November 4, 2011 updated by: Kaiser Permanente

Binge Eating Self-Guided Treatment (BEST)

This study will determine the effectiveness of guided self-help treatment in treating individuals with binge eating disorder (BED).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Binge eating disorder (BED) is a serious condition characterized by compulsive overeating and feelings of powerlessness. The condition often has a negative impact on both physical and emotional health. This study will examine ways to help people determine whether they have BED and will test whether guided self-help (GSH) treatment is effective in treating BED.

Participants will be randomly assigned to receive either GSH treatment or usual clinical care (which may include general support and talk therapy) for 3 months. The GSH treatment is a cognitive behavioral therapy-based program that will be administered over 8 sessions. Participants receiving GSH will be given a book that focuses on dealing with BED; they will also meet with a therapist regularly to have their progress monitored. The Eating Disorders Examination (EDE), self-reports, questionnaires, and surveys will be used to assess participants. Assessments will be conducted at study entry, at Weeks 2 and 4 of the treatment, at the end of the treatment, and at 6 and 12 months post-treatment.

Study Type

Interventional

Enrollment (Actual)

284

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
    • Connecticut
      • Middletown, Connecticut, United States, 06459
        • Wesleyan University Department of Psychology
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of binge eating disorder (BED) bulimia nervosa (BN), or spectrum BN, defined as recurrent binge eating at least once a week for 3 months
  • Body mass index (BMI) between 18 and 45
  • Continuous membership in the Kaiser Permanente Northwest Division for at least 12 months prior to study entry

Exclusion Criteria:

  • Diagnosis of anorexia nervosa or psychotic disorder
  • Significant organic brain syndromes, retardation, pervasive developmental disorder, or autism
  • At risk for suicide
  • Pregnancy

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Participants will receive treatment as usual
Behavioral: Usual clinical care
Control group participants receive treatment as usual.
Experimental: 1
Participants will receive guided self-help cognitive behavioral therapy
Behavioral: Guided self-help cognitive behavioral therapy (CBT)
Participants receive eight sessions of guided self-help CBT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of binge eating
Time Frame: Measured at post-treatment, Week 12, Month 6, and Year 1
Measured at post-treatment, Week 12, Month 6, and Year 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of inappropriate compensatory behaviors, dietary restraint, over-valuation of weight/shape, functional impairment, self-esteem, and social impairment
Time Frame: Measured at post-treatment, Week 12, Month 6, and Year 1
Measured at post-treatment, Week 12, Month 6, and Year 1
Body weight
Time Frame: Measured at post-treatmentand Year 1
Measured at post-treatmentand Year 1

Collaborators and Investigators

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

Sponsor

Kaiser Permanente

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Ruth H. Striegel-Moore, PhD, Wesleyan 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

August 1, 2004

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

November 6, 2011

Last Update Submitted That Met QC Criteria

November 4, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH066966 (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.

Clinical Trials on Bulimia

Clinical Trials on Guided self-help cognitive behavioral therapy (CBT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe