NCT07218302

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_2

Timeline
39mo left

Started Mar 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Jul 2029

First Submitted

Initial submission to the registry

October 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

3.4 years

First QC Date

October 15, 2025

Last Update Submit

October 20, 2025

Conditions

Keywords

Eating Disorder InterventionEating PathologyEating Disorder SymptomsDigital Mental HealthChatbotOptimization Randomized Control TrialMultiphase Optimization Strategy

Outcome Measures

Primary Outcomes (1)

  • ED psychopathology; ED Examination-Questionnaire (EDE-Q)

    The EDE-Q is a 28-item inventory derived from an ED diagnostic interview, which asks self-reported concerns with weight and shape, and engagement in ED behaviors, over the last 28 days. Each item is scored from 0-6, with 0 being "No days" and 6 being "Every day". An average is taken of all items participants respond to for a total global score (with possible scores ranging from 0 to 6), where higher scores indicate greater symptomology.

    6 months

Secondary Outcomes (4)

  • ED behaviors from the EDE-Q; Muscle Building Subscale from the Eating Pathology Symptoms Inventory (EPSI)

    6 months

  • Depression; Patient Health Questionnaire (PHQ-9)

    6 months

  • Anxiety; Generalized Anxiety Disorder (GAD-7)

    6 months

  • Clinical Impairment; Clinical Impairment Assessment (CIA)

    6 months

Study Arms (16)

Chatbot targeting weight & shape over-evaluation (WSC)

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting dietary restraint (DR)

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting emotion dysregulation (ED)

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting resisting urges to binge (UB)

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting WSC and DR

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting WSC and ED

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting WSC and UB

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting DR and ED

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting DR and UB

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting ED and UB

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting ED; UB; and DR

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting ED; UB; and WSC

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting ED; DR; and WSC

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Chatbot targeting UB; DR; and WSC

EXPERIMENTAL

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

Behavioral: Digital Chatbot Program

Chatbot targeting UB; DR; ED; and WSC

EXPERIMENTAL

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.

Behavioral: Digital Chatbot Program

Referral to seek services

NO INTERVENTION

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

Interventions

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.

Chatbot targeting DR and EDChatbot targeting DR and UBChatbot targeting ED and UBChatbot targeting ED; DR; and WSCChatbot targeting ED; UB; and DRChatbot targeting ED; UB; and WSCChatbot targeting UB; DR; ED; and WSCChatbot targeting UB; DR; and WSCChatbot targeting WSC and DRChatbot targeting WSC and EDChatbot targeting WSC and UBChatbot targeting dietary restraint (DR)Chatbot targeting emotion dysregulation (ED)Chatbot targeting resisting urges to binge (UB)Chatbot targeting weight & shape over-evaluation (WSC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63105, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Ellen Fitzsimmons-Craft, Ph.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychological & Brain Sciences and Psychiatry

Study Record Dates

First Submitted

October 15, 2025

First Posted

October 20, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

July 31, 2029

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Study protocol and informed consent form

Shared Documents
STUDY PROTOCOL, ICF

Locations