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Completed

NCT Number: NCT01949649

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

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.

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Key information

Age range

17 year–22 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Institute, Corvallis, Oregon, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer-Led Group Intervention

Behavioral

Internet-Based Intervention

Behavioral

Clinician-Led Group Intervention

Behavioral

Education Video

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2019
First posted
Sep 24, 2013
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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