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.

Study Overview

• Status: Completed
• Conditions: Eating Disorders
• Intervention / Treatment: Behavioral: StudentBodies - Eating Disorders

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.

• Study Type: Interventional
• Enrollment (Actual): 690
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: StudentBodies - Eating Disorders; Participants will participate in the StudentBodies - Eating Disorders program	Behavioral: StudentBodies - 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.
NO_INTERVENTION: Usual Care; Participants will be referred to treatment per protocol at students' corresponding college's mental health services center

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Mental Health (NIMH); Stanford University
• Investigators: Principal Investigator: Denise E. Wilfley, Ph.D., Washington University School of Medicine; Principal Investigator: C. Barr Taylor, M.D., Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2014
• Primary Completion (ACTUAL): November 27, 2018
• Study Completion (ACTUAL): November 27, 2018

Study Registration Dates

• First Submitted: February 26, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (ESTIMATE): March 3, 2014

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: R01MH100455 (NIH); 5R01MH100455 (NIH)