Adolescent Chatbot

NCT07094503 | Recruiting Phase 2

• 1 other identifier: 202501059
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Body Image Disturbance; Disordered Eating Behaviors; Eating Disorder Prevention

Keywords

Adolescents; Disordered Eating Behaviors; Eating Disorder Symptoms; Eating Pathology; Eating disorder Prevention; Body Image; Body Image Disturbance; Digital Mental Health; Chatbot

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Chatbot Intervention Condition

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

Participants receive access to the digital chatbot program after 6 months and completion of the study.

Interventions

Wysa Digital Chatbot Program BEHAVIORAL

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.

Chatbot Intervention Condition

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old
• Owns a smartphone
• Speaks English
• US resident
• Screens as at-risk for an eating disorder
• Not currently in treatment for an eating disorder

You may not qualify if:

• Below 13 or older than 17 years of age
• Does not own a smartphone
• Does not speak English
• Lives outside the US
• Screens as:
• Having a subclinical or clinical ED
• Not at risk for an ED
• In treatment for an ED

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

Related Links

• Prescreen to the Study

MeSH Terms

Conditions

Disordered Eating Behavior

Condition Hierarchy (Ancestors)

Behavior; Feeding and Eating Disorders; Mental Disorders

Study Officials

• Ellen Fitzsimmons-Craft, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie A Gullo, B.S/B.A.

CONTACT

314-935-5843; Gullo@wustl.edu

Marianna Horton, B.S./B.A.

CONTACT

314-935-5843; M.horton@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychological & Brain Sciences

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: June 18, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)