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

Eating Disorder Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949649
• Other study ID #: MH097720
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: March 2019

Study information

• Verified date: April 2019
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: March 2019
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Eating Disorder Prevention
• Feeding and Eating Disorders

Intervention

Behavioral:
• Peer-Led Group Intervention

• Internet-Based Intervention

• Clinician-Led Group Intervention

• Education Video

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas
United States	Oregon Research Institute	Corvallis	Oregon
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

Fairburn CG, Harrison PJ. Eating disorders. Lancet. 2003 Feb 1;361(9355):407-16. Review. — View 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. Epub 2006 Jul 3. Erratum in: Biol Psychiatry. 2012 Jul 15;72(2):164. — View 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. — View Citation

Newman DL, Moffitt TE, Caspi A, Magdol L, Silva PA, Stanton WR. Psychiatric disorder in a birth cohort of young adults: prevalence, comorbidity, clinical significance, and new case incidence from ages 11 to 21. J Consult Clin Psychol. 1996 Jun;64(3):552-62. — View 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. — View 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. — View 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. Epub 2012 Apr 16. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change over time: Body Dissatisfaction	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
Primary	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	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