NCT07237607

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

November 14, 2025

Last Update Submit

April 14, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Number of times participants use web-app.

    The investigators will measure the number of times participants use the web-app

    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

    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.

    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.

    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.

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

Secondary Outcomes (7)

  • Clinical Impairment Assessment (CIA)

    Baseline, End-of-Treatment (Week 6)

  • Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)

    Baseline, End-of-Treatment (Week 6)

  • Eating Disorder Fear Questionnaire (EDFQ)

    Baseline, End-of-Treatment (Week 6)

  • Fear of Food Measure (FOFM)

    Baseline, End-of-Treatment (Week 6)

  • Generalized Anxiety Disorder-7 (GAD-7)

    Baseline, End-of-Treatment (Week 6)

  • +2 more secondary outcomes

Other Outcomes (1)

  • Columbia Suicide Severity Rating Scale (CSSRS)

    Baseline

Study Arms (1)

"Exp-ED" Digital Exposure-Therapy Chatbot app

EXPERIMENTAL

Exp-ED will target anxiety about weight gain through an exposure based treatment.

Behavioral: "Exp-ED" Digital Exposure-Therapy Chatbot app

Interventions

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.

"Exp-ED" Digital Exposure-Therapy Chatbot app

Eligibility Criteria

Age12 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia NervosaBulimia NervosaBinge-Eating Disorder

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 20, 2025

Study Start

March 23, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations