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Eating DisordersPhase 2NCT07218302

Eating Disorder Chatbot Optimization

A Phase 2 study testing Digital Chatbot Program in people with Eating Disorders, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Eating Disorders
What is being tested?
Digital Chatbot Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
1 siteUnited States
Study dates
17 Jul 2026to 31 Jul 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18+ years old
  • Owns a smartphone
  • Speaks English
  • US resident
  • Screens for a clinical or subclinical eating disorder
  • Low suicidality
Show all 9Show fewer
  • Not currently in treatment for an eating disorder
  • Does not have a medical condition or take medications that impact appetite/weight
  • Not currently pregnant

Who cannot join

  • 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
Show all 9Show fewer
  • In treatment for an eating disorder
  • Has a medical condition or takes medication(s) that impact appetite/weight
  • Currently pregnant

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

3149355843

m.horton@wustl.edu

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

6469195177

gullo@wustl.edu

United States1 site, 1 recruiting
  • Washington University in St. Louis

    St Louis, Missouri, 63105

    Marianna B. Horton, B.S./B.A., 3149355843, m.horton@wustl.edu

    Ellen Fitzsimmons-Craft, Ph.D.

    Recruiting

Other trials in United States

About this study

Official title: Optimizing an Automated Chatbot to Achieve Efficient, Scalable Treatment for Eating Disorders

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

Read the detailed description

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.

Being tested
Digital Chatbot Program
Keywords
Eating Disorder Intervention, Eating Pathology, Eating Disorder Symptoms, Digital Mental Health, Chatbot, Optimization Randomized Control Trial, Multiphase Optimization Strategy
Medical subject headings
Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Chatbot ProgramBehavioural

    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.

Study groups in NCT07218302
Study groupRoleWhat they receive
Chatbot targeting weight & shape over-evaluation (WSC)ExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting dietary restraint (DR)ExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting emotion dysregulation (ED)ExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting resisting urges to binge (UB)ExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting WSC and DRExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting WSC and EDExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting WSC and UBExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting DR and EDExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting DR and UBExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting ED and UBExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting ED; UB; and DRExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting ED; UB; and WSCExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting ED; DR; and WSCExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting UB; DR; and WSCExperimentalParticipant 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
Receives: Behavioral: Digital Chatbot Program
Chatbot targeting UB; DR; ED; and WSCExperimentalParticipant 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.
Receives: Behavioral: Digital Chatbot Program
Referral to seek servicesNo interventionThose randomized to receive all chatbot components "off" will receive a referral to seek services.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (4)
  1. ED behaviors from the EDE-Q; Muscle Building Subscale from the Eating Pathology Symptoms Inventory (EPSI)

    The EDE-Q will also be used to gauge self-reported engagement in ED behaviors. Additionally, the EPSI Muscle Building subscale will be used which is a 5-item questionnaire that asks self-reported frequency of muscle building behaviors and attitudes over the last 28 days. Each item is scored from 0 ("Never") to 4 ("Very Often"). Subscale score is calculated by summing items participants respond to (scores may range from 0 to 20), and higher scores indicate greater symptomology.

    Measured: 6 months

  2. Depression; Patient Health Questionnaire (PHQ-9)

    The PHQ-9 is a 9-item scale asking about self-reported depressive symptoms and suicidality over the past two weeks. All items are scored from 0 ("Not at all") to 3 ("Nearly every day"). Items participants respond to are summed (possible scores ranging from 0 to 27), and higher scores indicate greater symptomology.

    Measured: 6 months

  3. Anxiety; Generalized Anxiety Disorder (GAD-7)

    The GAD-7 is a 7-item scale assessing self-reported symptoms of anxiety over the past two weeks. All items are scored from 0 ("Not at all") to 3 ("Nearly every day"). Items participants respond to are summed (possible scores ranging from 0 to 21), and higher scores indicate greater symptomology.

    Measured: 6 months

  4. Clinical Impairment; Clinical Impairment Assessment (CIA)

    The CIA is a 16-item measure that assesses self-reported impairment, or impact on one's life, resulting from eating, weight, or shape in the last 28 days. All items are scores from 0 ("Not at all") to 3 ("A lot"). Items participants respond to are summed (possible scores ranging from 0 to 48), and higher scores indicate greater impairment.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2025
  2. Study start17 Jul 2026
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07218302
Sponsor's protocol ID
202505037
Status last verified
Jul 2026
First submitted
15 Oct 2025
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol and informed consent form

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Digital Chatbot Program in people with Eating Disorders, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marianna B. Horton, B.S./B.A. (3149355843, m.horton@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ED psychopathology; ED Examination-Questionnaire (EDE-Q) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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