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NCT Number: NCT07237607

Developing an Artificial Intelligence (AI) 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.

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Key information

Conditions

Eating Disorders Anorexia Nervosa Binge-Eating Disorder Bulimia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

12 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location status: Recruiting

Location contact

Jamal H Essayli, PhD

CONTACT

[email protected]

717-531-0003 ext. 320191

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • Diagnosis of avoidant/restrictive food intake disorder (ARFID)
  • Have acute suicidality
  • Diagnosis of an intellectual disability

Treatment and study plan

"Exp-ED" Digital Exposure-Therapy Chatbot app

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Clinical Impairment Assessment (CIA)

    Time frame: Baseline, End-of-Treatment (Week 6)

    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.

  2. Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)

    Time frame: Baseline, End-of-Treatment (Week 6)

    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.

  3. Eating Disorder Fear Questionnaire (EDFQ)

    Time frame: Baseline, End-of-Treatment (Week 6)

    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.

  4. Fear of Food Measure (FOFM)

    Time frame: Baseline, End-of-Treatment (Week 6)

    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.

  5. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline, End-of-Treatment (Week 6)

    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.

  6. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, End-of-Treatment (Week 6)

    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.

  7. Eating Anxiety Questionnaire

    Time frame: Baseline, End of Week 2, End of Week 4, End-of-Treatment (Week 6)

    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.

Other outcomes

  1. Columbia Suicide Severity Rating Scale (CSSRS)

    Time frame: Baseline

    Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).

Study contacts

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

Jamal H Essayli, PhD

CONTACT

[email protected]

(717) 531-0003 ext. 320191

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Developing an Artificial Intelligence (AI)-Powered Exposure Therapy Chatbot for Adolescents and Young Adults With Eating Disorders

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2025
Registry last updated
Apr 15, 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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