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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Eating Disorder Prevention

Intervention / Treatment
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* Behavioral: Peer-Led Group Intervention
* Behavioral: Internet-Based Intervention
* Behavioral: Clinician-Led Group Intervention
* Behavioral: Education Video


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peer-Led Group Intervention<br>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<br> <br> |
| Active Comparator: Clinician-Led Group Intervention<br>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<br> <br> |
| Active Comparator: Internet-Based Intervention<br>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<br> <br> |
| Active Comparator: Education Video<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time: Eating disorder diagnostic interview | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body image, body dissatisfaction