Dissonance Eating Disorder Prevention: Clinician Led, Peer Led vs Web Delivered

April 17, 2019 updated by: Oregon Research Institute

Dissonance Eating Disorder Prevention: Clinician Led, Peer Led vs Web Delivered (Formerly: Effectiveness Trial of Peer-Led Dissonance Eating Disorder Prevention Groups)

Five percent of young women meet criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder, with another 5% meeting criteria for Eating Disorder Not Otherwise Specified (ED-NOS), which includes subthreshold variants of these disorders. Over half of those presenting for eating disorder treatment meet criteria for ED-NOS and both threshold cases and ED-NOS are marked by chronicity, relapse, distress, functional impairment, and increased risk for future obesity, depression, suicide attempts, anxiety disorders, substance abuse, morbidity, and mortality. Anorexia and bulimia nervosa show stronger relations to suicide attempts, outpatient/inpatient treatment, and functional impairment than most other psychiatric disorders. Treatment of eating disorders is very expensive, similar to the cost for schizophrenia treatment, and is effective for only 40-60% of patients. Thus, a public health priority is to develop and disseminate effective eating disorder prevention programs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although dozens of eating disorder prevention programs have been evaluated, only a dissonance-based program (the Body Project) has significantly reduced future onset of threshold and subthreshold eating disorders through long-term follow-up. An effectiveness trial found that the Body Project produced significant reductions in risk factors, eating disorder symptoms, and functional impairment relative to educational brochure controls, with some effects persisting through 3-yr follow-up when high school clinicians recruited students and delivered the program. These trials confirm the efficacy and effectiveness of the Body Project, but revealed a key dissemination barrier; it can be difficult to identify and recruit clinicians at high schools and colleges with the time and expertise to competently deliver the program.

One solution to this key dissemination barrier is to train students in established peer leader programs at colleges to recruit high-risk students and deliver the program. Another solution to this dissemination barrier would be to deliver the Body Project via the Internet.

Because peer-led groups and Internet delivery of the Body Project could markedly extend the reach and sustainability of this evidence-based program, we propose to conduct the first large multi-site effectiveness trial that directly compares the effects and cost effectiveness of peer-led Body Project groups, the eBody Project intervention, and clinician-led Body Project groups to an educational video control condition.

Study Type

Interventional

Enrollment (Actual)

680

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
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Oregon Research Institute
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute
    • Texas
      • Austin, Texas, United States, 78712
        • University of Texas at Austin

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

17 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Body image concerns
  • Attend University of Oregon, Oregon State University, University of Texas at Austin, or Southwestern University

Exclusion Criteria:

  • Meeting criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder
  • Suicidal ideation

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Peer-Led Group Intervention
In the Peer-Led Group Intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique the thin-ideal ideal during 4 1-hr sessions and in homework activities which are led by peer leaders.
Behavioral: Peer-Led Group Intervention
Active Comparator: Clinician-Led Group Intervention
In the Clinician-Led Group Intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique the thin-ideal ideal during 4 1-hr sessions and in homework activities which are led by University clinicians.
Behavioral: Clinician-Led Group Intervention
Active Comparator: Internet-Based Intervention
The Internet-Based Intervention consists of 6 40-min modules involving user-driven self-education activities and games (e.g., role-plays), writing/video contests, and off-line exercises designed to induce dissonance regarding pursuit of the thin-ideal, mirroring activities from the group Body Project.
Behavioral: Internet-Based Intervention
Active Comparator: Education Video
The Education Video describes eating disorders, their adverse effects, and the need for treatment, which is key information to provide to young women at elevated risk for eating disorders due to body dissatisfaction.
Behavioral: Education Video

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change over time: Eating disorder diagnostic interview
Time Frame: baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2-, and 3-year follow-ups
Participants will complete an interview assessing Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) eating disorder symptoms.
baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2-, and 3-year follow-ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change over time: Thin-ideal internalization
Time Frame: baseline obtained on intake, 1 month post intervention and 6mo-, 1-, 2-, & 3-year followups
Thin-ideal internalization will be assessed with the 8-item Ideal-Body Stereotype Scale-Revised. Participants respond using a 5-point response format.
baseline obtained on intake, 1 month post intervention and 6mo-, 1-, 2-, & 3-year followups

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change over time: Body Dissatisfaction
Time Frame: baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2- & 3-yr followups
Body dissatisfaction will be assessed with the Body Dissatisfaction Scale. Respondents rate their level of satisfaction with 9 body parts on 6-point scales.
baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2- & 3-yr followups

Collaborators and Investigators

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

Sponsor

Oregon Research Institute

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 (Actual)

April 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH097720

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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