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OpenTrials
Completed

NCT Number: NCT02076464

Using Technology to Improve Eating Disorders Treatment

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

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Key information

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StudentBodies - Eating Disorders

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Stanford University

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2014
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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