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

Primary Purpose

Eating Disorder Prevention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-Led Group Intervention
Internet-Based Intervention
Clinician-Led Group Intervention
Education Video
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Disorder Prevention focused on measuring body image, body dissatisfaction

Eligibility Criteria

17 Years - 22 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Oregon Research Institute
  • Oregon Research Institute
  • University of Texas at Austin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Peer-Led Group Intervention

Clinician-Led Group Intervention

Internet-Based Intervention

Education Video

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 17, 2013
Last Updated
April 17, 2019
Sponsor
Oregon Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01949649
Brief Title
Dissonance Eating Disorder Prevention: Clinician Led, Peer Led vs Web Delivered
Official Title
Dissonance Eating Disorder Prevention: Clinician Led, Peer Led vs Web Delivered (Formerly: Effectiveness Trial of Peer-Led Dissonance Eating Disorder Prevention Groups)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder Prevention
Keywords
body image, body dissatisfaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
680 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer-Led Group Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Clinician-Led Group Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Internet-Based Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Education Video
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer-Led Group Intervention
Intervention Type
Behavioral
Intervention Name(s)
Internet-Based Intervention
Intervention Type
Behavioral
Intervention Name(s)
Clinician-Led Group Intervention
Intervention Type
Behavioral
Intervention Name(s)
Education Video
Primary Outcome Measure Information:
Title
Change over time: Eating disorder diagnostic interview
Description
Participants will complete an interview assessing Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) eating disorder symptoms.
Time Frame
baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2-, and 3-year follow-ups
Secondary Outcome Measure Information:
Title
Change over time: Thin-ideal internalization
Description
Thin-ideal internalization will be assessed with the 8-item Ideal-Body Stereotype Scale-Revised. Participants respond using a 5-point response format.
Time Frame
baseline obtained on intake, 1 month post intervention and 6mo-, 1-, 2-, & 3-year followups
Other Pre-specified Outcome Measures:
Title
Change over time: Body Dissatisfaction
Description
Body dissatisfaction will be assessed with the Body Dissatisfaction Scale. Respondents rate their level of satisfaction with 9 body parts on 6-point scales.
Time Frame
baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2- & 3-yr followups

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Stice, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19803563
Citation
Stice E, Rohde P, Gau J, Shaw H. An effectiveness trial of a dissonance-based eating disorder prevention program for high-risk adolescent girls. J Consult Clin Psychol. 2009 Oct;77(5):825-34. doi: 10.1037/a0016132.
Results Reference
background
PubMed Identifier
21707136
Citation
Stice E, Rohde P, Shaw H, Gau J. An effectiveness trial of a selected dissonance-based eating disorder prevention program for female high school students: Long-term effects. J Consult Clin Psychol. 2011 Aug;79(4):500-8. doi: 10.1037/a0024351.
Results Reference
background
PubMed Identifier
22122289
Citation
Stice E, Rohde P, Shaw H, Marti CN. Efficacy trial of a selective prevention program targeting both eating disorder symptoms and unhealthy weight gain among female college students. J Consult Clin Psychol. 2012 Feb;80(1):164-170. doi: 10.1037/a0026484. Epub 2011 Nov 28.
Results Reference
background
PubMed Identifier
22506791
Citation
Stice E, Rohde P, Durant S, Shaw H. A preliminary trial of a prototype Internet dissonance-based eating disorder prevention program for young women with body image concerns. J Consult Clin Psychol. 2012 Oct;80(5):907-16. doi: 10.1037/a0028016. Epub 2012 Apr 16.
Results Reference
background
PubMed Identifier
16815322
Citation
Hudson JI, Hiripi E, Pope HG Jr, Kessler RC. The prevalence and correlates of eating disorders in the National Comorbidity Survey Replication. Biol Psychiatry. 2007 Feb 1;61(3):348-58. doi: 10.1016/j.biopsych.2006.03.040. Epub 2006 Jul 3. Erratum In: Biol Psychiatry. 2012 Jul 15;72(2):164.
Results Reference
background
PubMed Identifier
23148784
Citation
Stice E, Marti CN, Rohde P. Prevalence, incidence, impairment, and course of the proposed DSM-5 eating disorder diagnoses in an 8-year prospective community study of young women. J Abnorm Psychol. 2013 May;122(2):445-57. doi: 10.1037/a0030679. Epub 2012 Nov 12.
Results Reference
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PubMed Identifier
16476129
Citation
Wade TD, Bergin JL, Tiggemann M, Bulik CM, Fairburn CG. Prevalence and long-term course of lifetime eating disorders in an adult Australian twin cohort. Aust N Z J Psychiatry. 2006 Feb;40(2):121-8. doi: 10.1080/j.1440-1614.2006.01758.x.
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PubMed Identifier
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Citation
Fairburn CG, Harrison PJ. Eating disorders. Lancet. 2003 Feb 1;361(9355):407-16. doi: 10.1016/S0140-6736(03)12378-1.
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Citation
Crow SJ, Peterson CB, Swanson SA, Raymond NC, Specker S, Eckert ED, Mitchell JE. Increased mortality in bulimia nervosa and other eating disorders. Am J Psychiatry. 2009 Dec;166(12):1342-6. doi: 10.1176/appi.ajp.2009.09020247. Epub 2009 Oct 15.
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PubMed Identifier
16715488
Citation
le Grange D, Binford RB, Peterson CB, Crow SJ, Crosby RD, Klein MH, Bardone-Cone AM, Joiner TE, Mitchell JE, Wonderlich SA. DSM-IV threshold versus subthreshold bulimia nervosa. Int J Eat Disord. 2006 Sep;39(6):462-7. doi: 10.1002/eat.20304.
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PubMed Identifier
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Citation
Schmidt U, Lee S, Perkins S, Eisler I, Treasure J, Beecham J, Berelowitz M, Dodge L, Frost S, Jenkins M, Johnson-Sabine E, Keville S, Murphy R, Robinson P, Winn S, Yi I. Do adolescents with eating disorder not otherwise specified or full-syndrome bulimia nervosa differ in clinical severity, comorbidity, risk factors, treatment outcome or cost? Int J Eat Disord. 2008 Sep;41(6):498-504. doi: 10.1002/eat.20533.
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PubMed Identifier
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Citation
Striegel-Moore RH, Leslie D, Petrill SA, Garvin V, Rosenheck RA. One-year use and cost of inpatient and outpatient services among female and male patients with an eating disorder: evidence from a national database of health insurance claims. Int J Eat Disord. 2000 May;27(4):381-9. doi: 10.1002/(sici)1098-108x(200005)27:43.0.co;2-u.
Results Reference
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PubMed Identifier
16649871
Citation
Stice E, Shaw H, Burton E, Wade E. Dissonance and healthy weight eating disorder prevention programs: a randomized efficacy trial. J Consult Clin Psychol. 2006 Apr;74(2):263-75. doi: 10.1037/0022-006X.74.2.263.
Results Reference
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PubMed Identifier
35653756
Citation
Stice E, Desjardins CD, Rohde P. Young women who develop anorexia nervosa exhibit a persistently low premorbid body weight on average: A longitudinal investigation of an important etiologic clue. J Psychopathol Clin Sci. 2022 Jul;131(5):479-492. doi: 10.1037/abn0000762. Epub 2022 Jun 2.
Results Reference
derived
PubMed Identifier
34152570
Citation
Akers L, Rohde P, Shaw H, Stice E. Cost-Effectiveness Comparison of Delivery Modalities for a Dissonance-Based Eating Disorder Prevention Program over 4-Year Follow-Up. Prev Sci. 2021 Nov;22(8):1086-1095. doi: 10.1007/s11121-021-01264-1. Epub 2021 Jun 21.
Results Reference
derived
PubMed Identifier
32534455
Citation
Stice E, Rohde P, Shaw H, Desjardins C. Weight suppression increases odds for future onset of anorexia nervosa, bulimia nervosa, and purging disorder, but not binge eating disorder. Am J Clin Nutr. 2020 Oct 1;112(4):941-947. doi: 10.1093/ajcn/nqaa146.
Results Reference
derived
PubMed Identifier
32091226
Citation
Stice E, Rohde P, Shaw H, Gau JM. Clinician-led, peer-led, and internet-delivered dissonance-based eating disorder prevention programs: Effectiveness of these delivery modalities through 4-year follow-up. J Consult Clin Psychol. 2020 May;88(5):481-494. doi: 10.1037/ccp0000493. Epub 2020 Feb 24.
Results Reference
derived
PubMed Identifier
28425735
Citation
Stice E, Rohde P, Shaw H, Gau JM. Clinician-led, peer-led, and internet-delivered dissonance-based eating disorder prevention programs: Acute effectiveness of these delivery modalities. J Consult Clin Psychol. 2017 Sep;85(9):883-895. doi: 10.1037/ccp0000211. Epub 2017 Apr 20.
Results Reference
derived

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

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