Trial record 15 of 90 for:    Open Studies | "Eating Disorders"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Oregon Research Institute
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT01949649
First received: September 17, 2013
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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 Intervention
Eating Disorder Prevention
Behavioral: Peer-Led Group Intervention
Behavioral: Internet-Based Intervention
Behavioral: Clinician-Led Group Intervention
Behavioral: Education Video

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline obtained on intake, 1 month post intervention and 6mo-, 1-, 2-, & 3-year followups ] [ Designated as safety issue: No ]
    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:
  • Change over time: Body Dissatisfaction [ Time Frame: baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2- & 3-yr followups ] [ Designated as safety issue: No ]
    Body dissatisfaction will be assessed with the Body Dissatisfaction Scale. Respondents rate their level of satisfaction with 9 body parts on 6-point scales.


Estimated Enrollment: 600
Study Start Date: April 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   17 Years to 22 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949649

Contacts
Contact: Kim R Martin, MS 541-484-2123 ext 2123 bodyproject@ori.org

Locations
United States, Oregon
Oregon Research Institute Recruiting
Corvallis, Oregon, United States, 97330
Principal Investigator: Eric Stice, PhD         
Sub-Investigator: Paul Rohde, PhD         
Sub-Investigator: Heather Shaw, PhD         
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Principal Investigator: Eric Stice, PhD         
Sub-Investigator: Paul Rohde, PhD         
Sub-Investigator: Heather Shaw, PhD         
United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Monique Cano, LPC-I    512-471-0808    mtc979@utexas.edu   
Principal Investigator: Eric Stice, PhD         
Sub-Investigator: David Drum, PhD         
Sub-Investigator: C. Nate Marti, PhD         
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Eric Stice, PhD Oregon Research Institute
  More Information

Additional Information:
Publications:

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT01949649     History of Changes
Other Study ID Numbers: MH097720
Study First Received: September 17, 2013
Last Updated: March 17, 2014
Health Authority: United States: Federal Government

Keywords provided by Oregon Research Institute:
body image
body dissatisfaction

Additional relevant MeSH terms:
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014