Eating DisordersNCT07237607
Developing an Artificial Intelligence (AI) Chatbot for Adolescents and Young Adults With Eating Disorders
A study testing "Exp-ED" Digital Exposure-Therapy Chatbot app in people with Eating Disorders and Anorexia Nervosa, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The goal of this study is to develop and refine an artificial intelligence (AI)-powered Exposure Therapy for Eating Disorders chatbot web-app that effectively engages adolescents and young adults and decreases anxiety about weight gain. Read more about this study
- Who is it for?
- Ages 12 to 26 years
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- "Exp-ED" Digital Exposure-Therapy Chatbot app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2026to 30 Jun 2027
- Phase
- Interventional
- 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 12 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age is between or equal to 12-26 years
- Admitted to the Penn State Health Eating Disorder Partial Hospital Program (PHP) or Intensive Outpatient Program (IOP)
- Have a personal smartphone
- Have a diagnosis of anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), or other specified feeding or eating disorder (OSFED)
- Be English speaking
Who cannot join
- Diagnosis of avoidant/restrictive food intake disorder (ARFID)
- Have acute suicidality
- Diagnosis of an intellectual disability
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
Penn State College of Medicine
Hershey, Pennsylvania, 17033
Jamal H Essayli, PhD, 717-531-0003 ext. 320191, jessayli@pennstatehealth.psu.edu
About this study
Official title: Developing an Artificial Intelligence (AI)-Powered Exposure Therapy Chatbot for Adolescents and Young Adults With Eating Disorders
The goal of this study is to develop and refine an artificial intelligence (AI)-powered Exposure Therapy for Eating Disorders chatbot web-app that effectively engages adolescents and young adults and decreases anxiety about weight gain. Participants will use the web-app as a supplemental therapeutic tool during their first six weeks of treatment in a Partial Hospitalization Program. Participants will complete assessments every two weeks, including: (1) semi-structured interviews about their experience with the chatbot web-app; (2) implementation outcome measures (e.g., feasibility, usability, acceptability); and (3) anxiety about weight gain.
Read the detailed description
The overarching goal of this study is to develop and refine an AI-powered Exposure Therapy for Eating Disorders (Exp-ED) chatbot app that effectively engages adolescents and young adults (AYAs) with eating disorders (EDs) and decreases anxiety about weight gain. The investigators will enroll 20 AYAs (ages 12-26 years) entering the Partial Hospitalization Program (PHP) for EDs at the Penn State Milton S. Hershey Medical Center. The initial version of the Exp-ED chatbot app will be developed by an interdisciplinary team with expertise in exposure therapy for EDs (Dr. Essayli), AI (Dr. Nawab), and implementation science (Dr. Lenker). Participants will use the Exp-ED chatbot app as a supplemental therapeutic tool during their first six weeks of PHP treatment. Participants will complete assessments every two weeks, including: (1) semi-structured interviews about their experience with the Exp-ED chatbot app, including design issues and engagement barriers; (2) implementation outcome measures (e.g., feasibility, usability, acceptability); and (3) anxiety about weight gain. Success will be evaluated using pre-determined benchmarks derived from previous mental health chatbot research. This project has two aims:
Aim 1: Iteratively adapt an exposure therapy chatbot app for AYAs with EDs. The investigators will conduct monthly reviews of mixed-methods data and use the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) to systematically document and evaluate modifications to the chatbot app. Each revised version will be tested with new participants, creating an iterative development process that continues throughout the project period. All adaptation decisions and their empirical foundations will be documented to create a comprehensive record of the app's development via implementation science frameworks.
Aim 2. Evaluate the feasibility, usability, acceptability, and preliminary efficacy of the Exp-ED chatbot app. H2.1: The investigators will recruit ≥50% of eligible AYAs with EDs. H2.2: Over the six-week project period, participants will use the app ≥18 times. H2.3: Participants will engage with the chatbot for ≥100 minutes total. H2.4: Participants will rate the Exp-ED chatbot app as acceptable (score ≥68 on the System Usability Scale). H2.5: Participants will report a ≥50% reduction in anxiety about weight gain.
- Being tested
- "Exp-ED" Digital Exposure-Therapy Chatbot app
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Exp-ED" Digital Exposure-Therapy Chatbot appBehavioural
Exp-ED is a text-based digital health application designed for smartphones and personal computers. It provides exposure-based content to adolescents and young adults with eating disorders. The chatbot guides users through exposure exercises (structured steps to reduce anxiety over time), records subjective distress ratings (self-reported anxiety scores), and offers evidence-based coping prompts. These sessions are intended to supplement clinical care during a six-week partial hospitalization program.
| Study group | Role | What they receive |
|---|---|---|
| "Exp-ED" Digital Exposure-Therapy Chatbot app | Experimental | Exp-ED will target anxiety about weight gain through an exposure based treatment. Receives: Behavioral: "Exp-ED" Digital Exposure-Therapy Chatbot app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of times participants use web-app.
The investigators will measure the number of times participants use the web-app
Measured: End of Week 2, End of Week 4, End-of-Treatment (Week 6)
Number of minutes participants engage with the web-app.
The investigators will measure the number of minutes participants engage with the web-app
Measured: End of Week 2, End of Week 4, End-of-Treatment (Week 6)
Percent of eligible Adolescents and Young Adults Consented
The investigators will measure the percent of eligible adolescents and young adults who consent to the study.
Measured: Through study completion, an average of 1 year
System Usability Scale Survey (SUS)
The System Usability Scale Survey (SUS) is a 10-item self-report questionnaire that examines the participant's attitude towards the web-app. Scores range from 10-50, with higher scores indicating a better overall experience with the app.
Measured: End of Week 2, End of Week 4, End-of-Treatment (Week 6)
Weight Gain Anxiety Questionnaire
The Weight Gain Anxiety Questionnaire is a 12-item self-report questionnaire that targets anxiety about weight gain. The scores are measured on a 0-100 scale, with the higher the score indicating more distress about weight gain, with the exception for question 12 which is reverse scored.
Measured: Baseline, End of Week 2, End of Week 4, End-of-Treatment (Week 6)
Secondary outcomes (7)
Clinical Impairment Assessment (CIA)
The Clinical Impairment Assessment Questionnaire (CIA) is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features and focuses on the past 28 days. The 16 items cover impairment in domains of life that are typically affected by eating disorder psychopathology: mood and self-perception, cognitive functioning, interpersonal functioning, and work performance. The responses are scored 0,1,2 and 3, with a higher rating indicating a higher level of impairment. The total range is between 0 and 48.
Measured: Baseline, End-of-Treatment (Week 6)
Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)
The Eating Disorder Examination Questionnaire (EDE-Q) is a 28-item self-report questionnaire. It was designed to assess the range, frequency, and severity of behaviors associated with a diagnosis of an eating disorder. A global score is obtained by summing the four subscales scores (ranging from 0-6) and dividing the total by the number of subscales (4). The score of items are calculated and range from 0 to 6. The higher score indicate greater ED symptoms.
Measured: Baseline, End-of-Treatment (Week 6)
Eating Disorder Fear Questionnaire (EDFQ)
The Eating Disorder Fear Questionnaire (EDFQ) is a 20-item self-report questionnaire. It examines the participant's severity of behaviors associated with a diagnosis of an eating disorder. The response range between 1 to 7 with a total range of 20 to 140. The higher rating indicates a higher severe impairment.
Measured: Baseline, End-of-Treatment (Week 6)
Fear of Food Measure (FOFM)
The Fear of Food Measure (FORM) is a 23-item self-report questionnaire. It examines the participant's severity of behaviors associated with a diagnosis of an eating disorder. Each item is scored on a 1-7 scale. The questionnaire range from 23 to 161 meaning 23: no fear of food and 161 meaning severe fear of food.
Measured: Baseline, End-of-Treatment (Week 6)
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 is a 7-item self-report questionnaire that targets anxiety symptoms. The scores range from 0 to 21, with higher scores indicating higher levels of anxiety.
Measured: Baseline, End-of-Treatment (Week 6)
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 is a 9-item self-report questionnaire that targets depressive symptoms. The scores range from 0-27, with higher scores indicating a higher level of depression.
Measured: Baseline, End-of-Treatment (Week 6)
Eating Anxiety Questionnaire
The Eating Gain Anxiety Questionnaire is a 14-item self-report questionnaire that targets anxiety about eating fear foods. The scores are measured on a 0-100 scale, with the higher the score indicating more distress about eating fear foods, with the exception for question 12 which is reverse scored.
Measured: Baseline, End of Week 2, End of Week 4, End-of-Treatment (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start23 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamal Essayli, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237607
- Sponsor's protocol ID
- 26987
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Artificial Intelligence (AI)-Powered Exposure Therapy Chatbot for Adolescents and Young Adults With Eating Disorders
- ClinicalTrials.gov ID
- NCT07237607
- Acronym / sponsor ID
- 26987
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Nov 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 goal of this study is to develop and refine an artificial intelligence (AI)-powered Exposure Therapy for Eating Disorders chatbot web-app that effectively engages adolescents and young adults and decreases anxiety about weight gain. Participants will use the web-app as a supplemental therapeutic tool during their first six weeks of treatment in a Partial Hospitalization Program. Participants will complete assessments every two weeks, including: (1) semi-structured interviews about their experience with the chatbot web-app; (2) implementation outcome measures (e.g., feasibility, usability, acceptability); and (3) anxiety about weight gain.
Detailed description
The overarching goal of this study is to develop and refine an AI-powered Exposure Therapy for Eating Disorders (Exp-ED) chatbot app that effectively engages adolescents and young adults (AYAs) with eating disorders (EDs) and decreases anxiety about weight gain. The investigators will enroll 20 AYAs (ages 12-26 years) entering the Partial Hospitalization Program (PHP) for EDs at the Penn State Milton S. Hershey Medical Center. The initial version of the Exp-ED chatbot app will be developed by an interdisciplinary team with expertise in exposure therapy for EDs (Dr. Essayli), AI (Dr. Nawab), and implementation science (Dr. Lenker). Participants will use the Exp-ED chatbot app as a supplemental therapeutic tool during their first six weeks of PHP treatment. Participants will complete assessments every two weeks, including: (1) semi-structured interviews about their experience with the Exp-ED chatbot app, including design issues and engagement barriers; (2) implementation outcome measures (e.g., feasibility, usability, acceptability); and (3) anxiety about weight gain. Success will be evaluated using pre-determined benchmarks derived from previous mental health chatbot research. This project has two aims:
Aim 1: Iteratively adapt an exposure therapy chatbot app for AYAs with EDs. The investigators will conduct monthly reviews of mixed-methods data and use the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) to systematically document and evaluate modifications to the chatbot app. Each revised version will be tested with new participants, creating an iterative development process that continues throughout the project period. All adaptation decisions and their empirical foundations will be documented to create a comprehensive record of the app's development via implementation science frameworks.
Aim 2. Evaluate the feasibility, usability, acceptability, and preliminary efficacy of the Exp-ED chatbot app. H2.1: The investigators will recruit ≥50% of eligible AYAs with EDs. H2.2: Over the six-week project period, participants will use the app ≥18 times. H2.3: Participants will engage with the chatbot for ≥100 minutes total. H2.4: Participants will rate the Exp-ED chatbot app as acceptable (score ≥68 on the System Usability Scale). H2.5: Participants will report a ≥50% reduction in anxiety about weight gain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "Exp-ED" Digital Exposure-Therapy Chatbot app | Experimental | Behavioral: "Exp-ED" Digital Exposure-Therapy Chatbot appExp-ED will target anxiety about weight gain through an exposure based treatment. |
Who may qualify
- Ages
- 12 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age is between or equal to 12-26 years
- Admitted to the Penn State Health Eating Disorder Partial Hospital Program (PHP) or Intensive Outpatient Program (IOP)
- Have a personal smartphone
- Have a diagnosis of anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), or other specified feeding or eating disorder (OSFED)
- Be English speaking
Key exclusion criteria (3 listed)
- Diagnosis of avoidant/restrictive food intake disorder (ARFID)
- Have acute suicidality
- Diagnosis of an intellectual disability
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 |
|---|---|---|
| "Exp-ED" Digital Exposure-Therapy Chatbot appExp-ED is a text-based digital health application designed for smartphones and personal computers. It provides exposure-based content to adolescents and young adults with eating disorders. The chatbot guides users through exposure exercises (structured steps to reduce anxiety over time), records subjective distress ratings (self-reported anxiety scores), and offers evidence-based coping prompts. These sessions are intended to supplement clinical care during a six-week partial hospitalization program. | Behavioural | "Exp-ED" Digital Exposure-Therapy Chatbot app |
Primary outcome
Number of times participants use web-app.
Time frame: End of Week 2, End of Week 4, End-of-Treatment (Week 6)
The investigators will measure the number of times participants use the web-app
Number of minutes participants engage with the web-app.
Time frame: End of Week 2, End of Week 4, End-of-Treatment (Week 6)
The investigators will measure the number of minutes participants engage with the web-app
Percent of eligible Adolescents and Young Adults Consented
Time frame: Through study completion, an average of 1 year
The investigators will measure the percent of eligible adolescents and young adults who consent to the study.
System Usability Scale Survey (SUS)
Time frame: End of Week 2, End of Week 4, End-of-Treatment (Week 6)
The System Usability Scale Survey (SUS) is a 10-item self-report questionnaire that examines the participant's attitude towards the web-app. Scores range from 10-50, with higher scores indicating a better overall experience with the app.
Weight Gain Anxiety Questionnaire
Time frame: Baseline, End of Week 2, End of Week 4, End-of-Treatment (Week 6)
The Weight Gain Anxiety Questionnaire is a 12-item self-report questionnaire that targets anxiety about weight gain. The scores are measured on a 0-100 scale, with the higher the score indicating more distress about weight gain, with the exception for question 12 which is reverse scored.
7 secondary outcomes
Clinical Impairment Assessment (CIA)
Time frame: Baseline, End-of-Treatment (Week 6)
Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)
Time frame: Baseline, End-of-Treatment (Week 6)
Eating Disorder Fear Questionnaire (EDFQ)
Time frame: Baseline, End-of-Treatment (Week 6)
Fear of Food Measure (FOFM)
Time frame: Baseline, End-of-Treatment (Week 6)
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, End-of-Treatment (Week 6)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, End-of-Treatment (Week 6)
Eating Anxiety Questionnaire
Time frame: Baseline, End of Week 2, End of Week 4, End-of-Treatment (Week 6)
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 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Exp-ED" Digital Exposure-Therapy Chatbot app in people with Eating Disorders and Anorexia Nervosa, run by Milton S. Hershey Medical Center 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 5 inclusion and 3 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 Apr 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.
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 Jamal H Essayli, PhD ((717) 531-0003 ext. 320191, jessayli@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of times participants use web-app. (time frame: End of Week 2, End of Week 4, End-of-Treatment (Week 6)). The study lists 5 primary outcomes in all. 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 Apr 2026.