Recruiting
Phase 2

Chatbot Intervention

Sponsor:

Washington University School of Medicine

Code:

NCT07218302

Conditions

Eating Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital Chatbot Program

Study Details

Brief summary:

The purpose of this study is to optimize an automated digital chatbot intervention for adults with clinical or subclinical eating disorders.

Conditions

Eating Disorders

Study ID

NCT07218302

Start date

Jul 17, 2026

Status verified date

Jul, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18+ years old
  • Owns a smartphone
  • Speaks English
  • US resident
  • Screens for a clinical or subclinical eating disorder
  • Low suicidality
  • Not currently in treatment for an eating disorder
  • Does not have a medical condition or take medications that impact appetite/weight
  • Not currently pregnant

Exclusion Criteria:

  • Below 18 years of age
  • Does not own a smartphone
  • Does not speak English
  • Lives outside the US
  • Screens as: at risk for an eating disorder, anorexia nervosa, atypical anorexia nervosa, avoidant/restrictive food intake disorder, or not at risk for an ED
  • High suicidality
  • In treatment for an eating disorder
  • Has a medical condition or takes medication(s) that impact appetite/weight
  • Currently pregnant

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chatbot targeting weight & shape over-evaluation (WSC)

Participant will have access to the chatbot component addressing weight \& shape over-evaluation. Participant will receive scheduled targeted practice for the weight \& shape over-evaluation component. At any time, participant will have access to initiate practice in assigned study component.

experimental: Chatbot targeting dietary restraint (DR)

Participant will have access to the chatbot component addressing dietary restraint. Participant will receive scheduled targeted practice for the dietary restraint component. At any time, participant will have access to initiate practice in assigned study component.

experimental: Chatbot targeting emotion dysregulation (ED)

Participant will have access to the chatbot component addressing emotion dysregulation. Participant will receive scheduled targeted practice for the emotion dysregulation component. At any time, participant will have access to initiate practice in assigned study component.

experimental: Chatbot targeting resisting urges to binge (UB)

Participant will have access to the chatbot component addressing resisting urges to binge. Participant will receive scheduled targeted practice for the resisting urges to binge component. At any time, participant will have access to initiate practice in assigned study component.

experimental: Chatbot targeting WSC and DR

Participant will have access to the chatbot components addressing weight \& shape over-evaluation and dietary restraint. Participant will receive scheduled targeted practice for the weight \& shape over-evaluation and dietary restraint components. At any time, participant will have access to initiate practice in assigned study components.

experimental: Chatbot targeting WSC and ED

Participant will have access to the chatbot components addressing weight \& shape over-evaluation and emotion deregulation. Participant will receive scheduled targeted practice for the weight \& shape over-evaluation and emotion dysregulation components. At any time, participant will have access to initiate practice in assigned study components.

experimental: Chatbot targeting WSC and UB

Participant will have access to the chatbot components addressing weight \& shape over-evaluation and resisting urges to binge. Participant will receive scheduled targeted practice for the weight \& shape over-evaluation and resisting urges to binge components. At any time, participant will have access to initiate practice in assigned study components.

experimental: Chatbot targeting DR and ED

Participant will have access to the chatbot components addressing dietary restraint and emotion deregulation. Participant will receive scheduled targeted practice for the dietary restraint and emotion dysregulation components. At any time, participant will have access to initiate practice in assigned study components.

experimental: Chatbot targeting DR and UB

Participant will have access to the chatbot components addressing dietary restraint and resisting urges to binge. Participant will receive scheduled targeted practice for the dietary restraint and resisting urges to binge components. At any time, participant will have access to initiate practice in assigned study components.

experimental: Chatbot targeting ED and UB

Participant will have access to the chatbot components addressing emotion dysregulation and resisting urges to binge. Participant will receive scheduled targeted practice for the emotion dysregulation and resisting urges to binge components. At any time, participant will have access to initiate practice in assigned study components.

experimental: Chatbot targeting ED; UB; and DR

Participant will have access to the chatbot components addressing emotion dysregulation, resisting urges to binge, and dietary restraint. Participant will receive scheduled targeted practice for the emotion dysregulation, resisting urges to binge, and dietary restraint components. At any time, participant will have access to initiate practice in assigned study components.

experimental: Chatbot targeting ED; UB; and WSC

Participant will have access to the chatbot components addressing emotion dysregulation, resisting urges to binge, and weight and shape over-evaluation. Participant will receive scheduled targeted practice for the emotion dysregulation, resisting urges to binge, and weight and shape over-evaluation components. At any time, participant will have access to initiate practice in assigned study components.

experimental: Chatbot targeting ED; DR; and WSC

Participant will have access to the chatbot components addressing emotion dysregulation, dietary restraint, and weight and shape over-evaluation. Participant will receive scheduled targeted practice for the emotion dysregulation, dietary restraint, and weight and shape over-evaluation components. At any time, participant will have access to initiate practice in assigned study components.

experimental: Chatbot targeting UB; DR; and WSC

Participant will have access to the chatbot components addressing resisting urges to binge, dietary restraint, and weight and shape over-evaluation. Participant will receive scheduled targeted practice for the resisting urges to binge, emotion dysregulation, dietary restraint and weight, and shape over-evaluation components. At any time, participant will have access to initiate practice in assigned study components

experimental: Chatbot targeting UB; DR; ED; and WSC

Participant will have access to the chatbot components addressing resisting urges to binge, dietary restraint, emotion dysregulation, and weight and shape over-evaluation. Participant will receive scheduled targeted practice for the resisting urges to binge, emotion dysregulation, dietary restraint, emotion dysregulation, and weight and shape over-evaluation components. At any time, participant will have access to initiate practice in assigned study components.

no intervention: Referral to seek services

Those randomized to receive all chatbot components "off" will receive a referral to seek services.

Interventions

Digital Chatbot Program

Wysa is a digital rules-based chatbot program platform offering cognitive-behavioral therapy-based guided self-help modules. Participants in an arm with access to Wysa will engage with the digital chatbot program daily for eight weeks.

Primary outcome measure

  • ED psychopathology; ED Examination-Questionnaire (EDE-Q) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

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

3149355843m.horton@wustl.edu

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

6469195177gullo@wustl.edu

Locations

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63105

Contacts

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

3149355843m.horton@wustl.edu

Principal Investigator:

Ellen Fitzsimmons-Craft, Ph.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Eating Disorder Intervention
  • Eating Pathology
  • Eating Disorder Symptoms
  • Digital Mental Health
  • Chatbot
  • Optimization Randomized Control Trial
  • Multiphase Optimization Strategy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-21.