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

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ClinicalTrials.gov Identifier: NCT01949649
Recruitment Status : Active, not recruiting
First Posted : September 24, 2013
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Eating Disorder Prevention Behavioral: Peer-Led Group Intervention Behavioral: Internet-Based Intervention Behavioral: Clinician-Led Group Intervention Behavioral: Education Video Not Applicable

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  (Clinical Trial)
Actual Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dissonance Eating Disorder Prevention: Clinician Led, Peer Led vs Web Delivered (Formerly: Effectiveness Trial of Peer-Led Dissonance Eating Disorder Prevention Groups)
Actual Study Start Date : April 2013
Actual Primary Completion Date : June 2015
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   17 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949649


Locations
United States, Oregon
Oregon Research Institute
Corvallis, Oregon, United States, 97330
Oregon Research Institute
Eugene, Oregon, United States, 97403
United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Eric Stice, PhD Oregon Research Institute

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT01949649     History of Changes
Other Study ID Numbers: MH097720
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Keywords provided by Oregon Research Institute:
body image
body dissatisfaction

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders