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NCT Number: NCT07218302

Eating Disorder Chatbot Optimization

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

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Key information

Conditions

Eating Disorders Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University in St. Louis

St Louis, Missouri, 63105, United States

Location status: Recruiting

Location contact

Ellen Fitzsimmons-Craft, Ph.D.

PRINCIPAL_INVESTIGATOR

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

CONTACT

[email protected]

3149355843

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Chatbot Program

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.

Primary outcomes

  1. ED psychopathology; ED Examination-Questionnaire (EDE-Q)

    Time frame: 6 months

    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.

Secondary outcomes

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

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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.

  4. Clinical Impairment; Clinical Impairment Assessment (CIA)

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

3149355843

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

CONTACT

[email protected]

6469195177

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • New York University
  • University of South Carolina

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Oct 20, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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