Body Image DisturbancePhase 2EMBodyNCT07094503
Adolescent Chatbot
A Phase 2 study testing Wysa Digital Chatbot Program in people with Body Image Disturbance and Disordered Eating Behaviors, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to test an eating disorders prevention digital chatbot program in a diverse group of adolescents. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Body Image Disturbance, Disordered Eating Behaviors, Eating Disorder Prevention
- What is being tested?
- Wysa Digital Chatbot Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2024to 30 Jul 2027
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 13 - 19 years old
- Owns a smartphone
- Speaks English
- US resident
- Screens as at-risk for an eating disorder
- Not currently in treatment for an eating disorder
Who cannot join
- Below 13 or older than 19 years of age
- Does not own a smartphone
- Does not speak English
- Lives outside the US
- Screens as:
- Having a subclinical or clinical ED
- Not at risk for an ED
- In treatment for an ED
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63130
Nathalie A Gullo, B.S./B.A., 314-935-5843, Gullo@wustl.edu
Marianna Horton, B.S./B.A., 314-935-5843, M.horton@wustl.edu
About this study
Official title: Improving Access to Services, Preventing Eating Disorders, and Addressing Comorbid Depression and Anxiety in Diverse Adolescents
The purpose of this study is to test an eating disorders prevention digital chatbot program in a diverse group of adolescents.
Read the detailed description
Eating disorders (EDs) are impacting youth at extreme rates, with up to 22% of adolescents reporting ED symptoms, and are associated with very high psychiatric comorbidity. Since adolescence is a critical period for the onset of eating disorders, prevention during this stage is essential to reducing lifetime prevalence. Interventions have been developed to prevent the onset of these devastating disorders, but these programs are generally not publicly available and rarely offer support for addressing comorbidity or the unique needs of vulnerable subpopulations (e.g., low-income populations, sexual and gender minorities, racial/ethnic minorities, those from rural areas), who are even less likely to have access to high-quality care. One scalable, engaging, easy-to use, and convenient approach to increasing access to evidence-based EDs prevention for underserved groups involves using a chatbot. This project will adapt our team's existing EDs prevention chatbot for use with adolescents, including those from diverse backgrounds, and evaluate its effectiveness. Our deep industry and non-profit partnerships will ensure scalability and ultimate real-world impact.
- Being tested
- Wysa Digital Chatbot Program
- Keywords
- Adolescents, Disordered Eating Behaviors, Eating Disorder Symptoms, Eating Pathology, Eating disorder Prevention, Body Image, Body Image Disturbance, Digital Mental Health, Chatbot
- Medical subject headings
- Disordered Eating Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wysa Digital Chatbot ProgramBehavioural
Wysa is a digital rules-based chatbot program platform offering cognitive-behavioral therapy-based guided self-help modules, including five modules for eating and body image developed by our team. Participants in this arm will engage with the digital chatbot program daily for three months to complete all five modules.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot Intervention Condition | Experimental | Participants receive access to the digital chatbot program featuring 5 CBT based modules for 3 months. Modules include psychoeducation and CBT-based exercises on regular eating and improving body image. Receives: Behavioral: Wysa Digital Chatbot Program |
| Waitlist Control | No intervention | Participants receive access to the digital chatbot program after 6 months and completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED risk factors; Weight Concerns Scale
Weight concerns scale as found in the Stanford Washington Eating Disorder (SWED) screen is a 5-item validated self-report questionnaire which measures concern with weight and dieting. Each item is scored on a 5-100 scale, then an average is computed across all 5 items for a 0-100 score.
Measured: 6 - months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start18 Jun 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Image DisturbanceStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen E. Fitzsimmons-Craft, Washington University School of Medicine
- Investigators
- Ellen Fitzsimmons-Craft, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094503
- Sponsor's protocol ID
- 202501059
- Acronym
- EMBody
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is not federally funded.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Services, Preventing Eating Disorders, and Addressing Comorbid Depression and Anxiety in Diverse Adolescents
- ClinicalTrials.gov ID
- NCT07094503
- Acronym / sponsor ID
- EMBody / 202501059
- Keywords
- Adolescents, Disordered Eating Behaviors, Eating Disorder Symptoms, Eating Pathology, Eating disorder Prevention, Body Image, Body Image Disturbance, Digital Mental Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test an eating disorders prevention digital chatbot program in a diverse group of adolescents.
Detailed description
Eating disorders (EDs) are impacting youth at extreme rates, with up to 22% of adolescents reporting ED symptoms, and are associated with very high psychiatric comorbidity. Since adolescence is a critical period for the onset of eating disorders, prevention during this stage is essential to reducing lifetime prevalence. Interventions have been developed to prevent the onset of these devastating disorders, but these programs are generally not publicly available and rarely offer support for addressing comorbidity or the unique needs of vulnerable subpopulations (e.g., low-income populations, sexual and gender minorities, racial/ethnic minorities, those from rural areas), who are even less likely to have access to high-quality care. One scalable, engaging, easy-to use, and convenient approach to increasing access to evidence-based EDs prevention for underserved groups involves using a chatbot. This project will adapt our team's existing EDs prevention chatbot for use with adolescents, including those from diverse backgrounds, and evaluate its effectiveness. Our deep industry and non-profit partnerships will ensure scalability and ultimate real-world impact.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot Intervention Condition | Experimental | Behavioral: Wysa Digital Chatbot ProgramParticipants receive access to the digital chatbot program featuring 5 CBT based modules for 3 months. Modules include psychoeducation and CBT-based exercises on regular eating and improving body image. |
| Waitlist Control | No intervention | –Participants receive access to the digital chatbot program after 6 months and completion of the study. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 13 - 19 years old
- Owns a smartphone
- Speaks English
- US resident
- Screens as at-risk for an eating disorder
Key exclusion criteria (8 listed)
- Below 13 or older than 19 years of age
- Does not own a smartphone
- Does not speak English
- Lives outside the US
- Screens as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wysa Digital Chatbot ProgramWysa is a digital rules-based chatbot program platform offering cognitive-behavioral therapy-based guided self-help modules, including five modules for eating and body image developed by our team. Participants in this arm will engage with the digital chatbot program daily for three months to complete all five modules. | Behavioural | Chatbot Intervention Condition |
Primary outcome
ED risk factors; Weight Concerns Scale
Time frame: 6 - months
Weight concerns scale as found in the Stanford Washington Eating Disorder (SWED) screen is a 5-item validated self-report questionnaire which measures concern with weight and dieting. Each item is scored on a 5-100 scale, then an average is computed across all 5 items for a 0-100 score.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Prescreen to the StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No. The study is not federally funded.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen Fitzsimmons-Craft, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Wysa Digital Chatbot Program in people with Body Image Disturbance and Disordered Eating Behaviors, 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 6 inclusion and 8 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 15 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 Mireya De Los Reyes, B.S/B.A. (314-935-5843, mireya@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED risk factors; Weight Concerns Scale (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 15 Jul 2026.