Using Technology to Improve Eating Disorders Treatment

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

Detailed Description
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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.

Official Title
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Using Technology to Improve Eating Disorders Treatment

Conditions
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Eating Disorders

Intervention / Treatment
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* Behavioral: StudentBodies - Eating Disorders


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StudentBodies - Eating Disorders<br>Participants will participate in the StudentBodies - Eating Disorders program | Behavioral: StudentBodies - Eating Disorders<br>* 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.<br>|
| No Intervention: Usual Care<br>Participants will be referred to treatment per protocol at students' corresponding college's mental health services center | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in eating disorder symptoms | Eating disorder outcomes will be measured using the Eating Disorder Examination Questionnaire | Measured at baseline, 6-months, 1-year, and 2-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Realized treatment access | 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 years | 
| Eating disorder behavior abstinence rates | Rates of bingeing and purging will be measured using the Eating Disorder Examination Questionnaire | 2 years | 
| Comorbid symptom severity and impairment | 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). | 2 years | 
| Service and implementation costs | Service and implementation costs will be assessed based on published rates. | up to 5 years |