Clinical trial NCT02076464: Using Technology to Improve Eating Disorders Treatment
Official title: Using Technology to Improve Eating Disorders Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Stanford University
First posted: 2014-03-03
Enrollment: 690
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Eligibility 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

Primary outcomes:
measure: Change in eating disorder symptoms
timeFrame: Measured at baseline, 6-months, 1-year, and 2-years
Secondary outcomes:
measure: Realized treatment access
timeFrame: 2 years
measure: Eating disorder behavior abstinence rates
timeFrame: 2 years
measure: Comorbid symptom severity and impairment
timeFrame: 2 years
measure: Service and implementation costs
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Denise E. Wilfley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: C. Barr Taylor, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fitzsimmons-Craft EE, Taylor CB, Graham AK, Sadeh-Sharvit S, Balantekin KN, Eichen DM, Monterubio GE, Goel NJ, Flatt RE, Karam AM, Firebaugh ML, Jacobi C, Jo B, Trockel MT, Wilfley DE. Effectiveness of a Digital Cognitive Behavior Therapy-Guided Self-Help Intervention for Eating Disorders in College Women: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2015633. doi: 10.1001/jamanetworkopen.2020.15633.