Adolescent Chatbot (EMBody)

Improving Access to Services, Preventing Eating Disorders, and Addressing Comorbid Depression and Anxiety in Diverse Adolescents

The purpose of this study is to test an eating disorders prevention digital chatbot program in a diverse group of adolescents.

Study Overview

• Status: Recruiting
• Conditions: Disordered Eating Behaviors; Body Image Disturbance; Eating Disorder Prevention
• Intervention / Treatment: Behavioral: Wysa Digital Chatbot Program

Detailed Description

Eating disorders (EDs) are impacting youth at extreme rates, with up to 22% of adolescents reporting ED symptoms, and are associated with very high psychiatric comorbidity. Since adolescence is a critical period for the onset of eating disorders, prevention during this stage is essential to reducing lifetime prevalence. Interventions have been developed to prevent the onset of these devastating disorders, but these programs are generally not publicly available and rarely offer support for addressing comorbidity or the unique needs of vulnerable subpopulations (e.g., low-income populations, sexual and gender minorities, racial/ethnic minorities, those from rural areas), who are even less likely to have access to high-quality care. One scalable, engaging, easy-to use, and convenient approach to increasing access to evidence-based EDs prevention for underserved groups involves using a chatbot. This project will adapt our team's existing EDs prevention chatbot for use with adolescents, including those from diverse backgrounds, and evaluate its effectiveness. Our deep industry and non-profit partnerships will ensure scalability and ultimate real-world impact.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mireya De Los Reyes, B.S/B.A.; Phone Number: 314-935-5843; Email: mireya@wustl.edu
• Study Contact Backup: Name: Marianna Mohr, B.S./B.A.; Phone Number: 314-935-5843; Email: mariannamohr@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Recruiting
      • Washington University in St. Louis
      • Contact: Marianna Horton, B.S./B.A.; Phone Number: 314-935-5843; Email: M.horton@wustl.edu
      • Contact: Nathalie A Gullo, B.S./B.A.; Phone Number: 314-935-5843; Email: Gullo@wustl.edu
      • Principal Investigator: Ellen E Fitzsimmons-Craft, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. 13 - 19 years old
2. Owns a smartphone
3. Speaks English
4. US resident
5. Screens as at-risk for an eating disorder
6. Not currently in treatment for an eating disorder

Exclusion Criteria:

1. Below 13 or older than 19 years of age
2. Does not own a smartphone
3. Does not speak English
4. Lives outside the US

5. Screens as:

   1. Having a subclinical or clinical ED
   2. Not at risk for an ED
   3. In treatment for an ED

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chatbot Intervention Condition; Participants receive access to the digital chatbot program featuring 5 CBT based modules for 3 months. Modules include psychoeducation and CBT-based exercises on regular eating and improving body image.	Behavioral: Wysa Digital Chatbot Program; Wysa is a digital rules-based chatbot program platform offering cognitive-behavioral therapy-based guided self-help modules, including five modules for eating and body image developed by our team. Participants in this arm will engage with the digital chatbot program daily for three months to complete all five modules.
No Intervention: Waitlist Control; Participants receive access to the digital chatbot program after 6 months and completion of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED risk factors; Weight Concerns Scale	Weight concerns scale as found in the Stanford Washington Eating Disorder (SWED) screen is a 5-item validated self-report questionnaire which measures concern with weight and dieting. Each item is scored on a 5-100 scale, then an average is computed across all 5 items for a 0-100 score.	6 - months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Ellen Fitzsimmons-Craft, PhD, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Prescreen to the Study

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: July 23, 2025
• First Submitted That Met QC Criteria: July 23, 2025
• First Posted (Actual): July 30, 2025

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Body Image; Chatbot; Digital Mental Health; Eating Disorder Symptoms; Body Image Disturbance; Disordered Eating Behaviors; Eating Pathology; Eating disorder Prevention
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Behavior; Disordered Eating Behavior
• Other Study ID Numbers: 202501059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study is not federally funded.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No