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Using Technology to Improve Eating Disorders Treatment

Using Technology to Improve Eating Disorders Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02076464
Enrollment
690
Registered
2014-03-03
Start date
2014-01-12
Completion date
2018-11-27
Last updated
2019-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorders

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.

Interventions

BEHAVIORALStudentBodies - 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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Stanford University
CollaboratorOTHER
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in eating disorder symptomsMeasured at baseline, 6-months, 1-year, and 2-yearsEating disorder outcomes will be measured using the Eating Disorder Examination Questionnaire

Secondary

MeasureTime frameDescription
Realized treatment access2 yearsRealized 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 rates2 yearsRates of bingeing and purging will be measured using the Eating Disorder Examination Questionnaire
Comorbid symptom severity and impairment2 yearsSymptom 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 costsup to 5 yearsService and implementation costs will be assessed based on published rates.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026