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Trial record 2 of 1160 for:    eating disorders

Using Technology to Improve Eating Disorders Treatment

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ClinicalTrials.gov Identifier: NCT02076464
Recruitment Status : Active, not recruiting
First Posted : March 3, 2014
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Stanford University
Information provided by (Responsible Party):
Denise Wilfley, Washington University School of Medicine

Brief Summary:
The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce eating disorder outcomes in college-age women.

Condition or disease Intervention/treatment Phase
Eating Disorders Behavioral: StudentBodies - Eating Disorders Not Applicable

Detailed Description:

Colleges are faced with an elevated prevalence of eating disorders, yet less than 20% of students report receiving treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for improved modalities for screening and intervention. Over the past 20 years, we have developed a comprehensive, online platform through which we identify and offer tailored evidence-based interventions to individuals across the eating disorder risk and diagnostic spectrum, using minimal person-based resources. The newest intervention in our suite of programs, Student Bodies-Eating Disorders (SB-ED), has not yet been tested in a large-scale trial or via platform delivery. The aim of this study is to conduct the first national deployment of our comprehensive platform and demonstrate that our transdiagnostic guided self-help program, SB-ED, yields measurable and significant improvements in access, costs, and outcomes for eating disorder treatment over referral to usual care (i.e., treatment per protocol at students' corresponding college's mental health services center).

Twenty-eight colleges will be randomly assigned to receive either SB-ED or referral to usual care. We will enroll at least 650 students from these campuses who screen positive for a DSM-5 clinical or subclinical eating disorder (excluding anorexia nervosa, which warrants more intensive medical monitoring). Outcomes will be measured at 6-months, 1-year, and 2-years following the completion of the online screen.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Using Technology to Improve Eating Disorders Treatment
Study Start Date : May 2013
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: StudentBodies - Eating Disorders
Participants will participate in the StudentBodies - Eating Disorders program
Behavioral: StudentBodies - Eating Disorders
The intervention is a structured, cognitive-behavioral guided self-help program, derived from manual-based cognitive-behavioral therapy. The intervention targets the core eating disorder pathology (e.g., extreme dietary restraint, overvaluation of shape and weight, binge eating, compensatory behaviors), focusing on helping users develop regular eating patterns, self-control strategies, problem-solving skills, and relapse prevention tools for maintenance of behavior change. The program includes daily symptom checklists, journal exercises and activities, and an asynchronous moderated online discussion group.

No Intervention: Usual Care
Participants will be referred to treatment per protocol at students' corresponding college's mental health services center



Primary Outcome Measures :
  1. Change in eating disorder symptoms [ Time Frame: Measured at baseline, 6-months, 1-year, and 2-years ]
    Eating disorder outcomes will be measured using the Eating Disorder Examination Questionnaire


Secondary Outcome Measures :
  1. Realized treatment access [ Time Frame: 2 years ]
    Realized treatment access is defined as receipt of eating disorder treatment and will be measured using medical records (when available) and a Health Care Utilization Questionnaire

  2. Eating disorder behavior abstinence rates [ Time Frame: 2 years ]
    Rates of bingeing and purging will be measured using the Eating Disorder Examination Questionnaire

  3. Comorbid symptom severity and impairment [ Time Frame: 2 years ]
    Symptom Severity includes depression, anxiety, alcohol use, eating disorder associated clinical impairment, and academic impairment. These symptoms will be measured using the Patient Health Questionnaire, the PROMIS anxiety questionnaire, an assessment of binge drinking, the Counseling Center Assessment of Psychological Symptoms, the Clinical Impairment Assessment, and academic transcripts (when available).

  4. Service and implementation costs [ Time Frame: up to 5 years ]
    Service and implementation costs will be assessed based on published rates.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Student at a participating college or university ages 18-30
  • Screen positive for DSM-5 bulimia nervosa, binge eating disorder, or a subclinical eating disorder

Exclusion Criteria:

  • Screen positive for DSM-5 anorexia nervosa
  • No access to the internet
  • Acutely suicidal

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): NCT02076464


Sponsors and Collaborators
Washington University School of Medicine
National Institute of Mental Health (NIMH)
Stanford University
Investigators
Principal Investigator: Denise E. Wilfley, Ph.D. Washington University School of Medicine
Principal Investigator: C. Barr Taylor, M.D. Stanford University

Responsible Party: Denise Wilfley, Principal Investigator, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02076464     History of Changes
Other Study ID Numbers: R01MH100455 ( U.S. NIH Grant/Contract )
5R01MH100455 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

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