Developing an Artificial Intelligence (AI) Chatbot for Adolescents and Young Adults With Eating Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-26
SponsorMilton S. Hershey Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Diagnosis of avoidant/restrictive food intake disorder (ARFID)
Have acute suicidality
Diagnosis of an intellectual disability
Trial design
Design model
Single group
Treatments tested in this trial
"Exp-ED" Digital Exposure-Therapy Chatbot app
BehavioralExp-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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: "Exp-ED" Digital Exposure-Therapy Chatbot appExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of times participants use web-app.
The investigators will measure the number of times participants use the web-app
Time frame
End of Week 2, End of Week 4, End-of-Treatment (Week 6)2
Number of minutes participants engage with the web-app.
The investigators will measure the number of minutes participants engage with the web-app
Time frame
End of Week 2, End of Week 4, End-of-Treatment (Week 6)3
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.
Time frame
Through study completion, an average of 1 year4
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.
Time frame
End of Week 2, End of Week 4, End-of-Treatment (Week 6)Secondary outcomes
1
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.
Time frame
Baseline, End-of-Treatment (Week 6)2
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.
Time frame
Baseline, End-of-Treatment (Week 6)3
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.
Time frame
Baseline, End-of-Treatment (Week 6)4
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.
Time frame
Baseline, End-of-Treatment (Week 6)Other outcomes
1
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov