Eating Disorder Chatbot Optimization

NCT ID: NCT07218302

Last Updated: 2025-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2029-07-31

Brief Summary

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

Detailed Description

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Eating disorders (EDs) are common-affecting an estimated 10% of individuals in their lifetimes-and have disabling consequences being associated with high psychiatric comorbidity, impairment, and mortality. Despite this, less than 20% of individuals with an ED ever receive treatment. When individuals do seek treatment, many are not evidence-based and come with high costs and burden on the healthcare system. One solution to this is a chatbot intervention that is evidence-based, affordable, and accessible for people with EDs. This project will assess four candidate components of a cognitive behavioral therapy (CBT)-based chatbot to determine the optimal chatbot package. CBT is the recommended first-line treatment for EDs, yet there is no research to date on which components are most effective or needed for meaningful change in ED psychopathology. In this study the intervention will be divided into four components targeting: (1) over-evaluation of weight and shape; (2) dietary restraint; (3) emotion dysregulation; and (4) resisting urges to binge. The investigators will recruit 800 adults with a binge/purge-type ED who are not currently in treatment and randomly assign participants to one of 16 experimental conditions (each combination from 1 to all 4 components) or the waitlist-control group. Participants will be assessed on changes in ED psychopathology, ED behavior frequencies, comorbid symptoms (i.e., depression, anxiety), and clinical impairment at 1-, 2-, and 6-months following randomization. An optimized package of these candidate components that is most effective, while remaining efficient, will be identified using multiphase optimization strategy (MOST). The investigators' established relationships with industry and non-profit partners will ensure this optimized package has high potential for scalability and dissemination into the community.

Conditions

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Eating Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Digital Chatbot Program

Intervention Type BEHAVIORAL

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.

Referral to seek services

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York University

OTHER

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Ellen E. Fitzsimmons-Craft

Associate Professor of Psychological & Brain Sciences and Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellen Fitzsimmons-Craft, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

Central Contacts

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

Role: CONTACT

3149355843

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

Role: CONTACT

6469195177

Facility Contacts

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

Role: primary

3149355843

Other Identifiers

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202505037

Identifier Type: -

Identifier Source: org_study_id

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