Clinical Trial: Using Technology to Improve Eating Disorders Treatment

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Using Technology to Improve Eating Disorders Treatment

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

Detailed Summary:

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.

Current Primary Outcome: Change in eating disorder symptoms [ Time Frame: Measured at baseline, 6-months, 1-year, and 2-years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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
• Eating disorder behavior abstinence rates [ Time Frame: 2 years ]
  Rates of bingeing and purging will be measured using the Eating Disorder Examination Questionnaire
• 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).
• Service and implementation costs [ Time Frame: up to 5 years ]
  Service and implementation costs will be assessed based on published rates.

Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: February 26, 2014
Date Started: May 2013
Date Completion: August 2018
Last Updated: April 26, 2016
Last Verified: April 2016