Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease

Last updated: November 7, 2025
Sponsor: University of Chicago
Overall Status: Completed

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Ulcers

Ulcerative Colitis

Treatment

Mental health support session

Clinical Study ID

NCT06575660
IRB24-0605
  • Ages > 18
  • All Genders

Study Summary

This is a small, exploratory study that will investigate using an artificial intelligence (AI) and virtual reality (VR), digital wellness application (app) to deliver a mental health support session in outpatient and hospitalized patients with inflammatory bowel disease (IBD) and co-existing symptoms of mild to moderate anxiety or depression.

The purpose of this study is to explore if a mental health support session using the app is feasible, safe, and acceptable to IBD patients and whether it could possibly help with physical and comorbid psychological symptoms of these patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18+ years of age

  • Patients with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)

  • English-speaking

  • Patients with score of 5-14 on General Anxiety Disorder-7 (GAD-7) questionnaire or 5-19 on Patient Health Questionnaire-9 (PHQ-9) within 3 months

  • Able to provide written consent

Exclusion

Exclusion Criteria:

  • Unwilling and/or unable to participate

  • Non-English speakers

  • Self-reported history of severe motion sickness

  • The presence of a facial/head deformity that will prohibit comfortably wearing of aVR headset

  • Legally blind or deaf

  • Having had a seizure in the past year

  • Unable to understand the instructions or to consent to participation in the study.

  • Those who are pregnant

Study Design

Total Participants: 22
Treatment Group(s): 1
Primary Treatment: Mental health support session
Phase:
Study Start date:
September 23, 2024
Estimated Completion Date:
October 09, 2025

Study Description

The mental health support session is delivered by a virtual reality digital wellness application (app). The app is a Chat GPT-4 powered AI and VR platform called XAIA (eXtended reality Artificially Intelligent Ally). [Chat GPT is an AI program that generates dialogue.] The app is publicly available on the Apple Vision Pro (a VR tool). It was developed by a group of providers, including a psychiatrist, at Cedars-Sinai Medical Center to devise a scalable solution for the increasing demand for mental wellness experiences. The application uses the combination of an AI-powered virtual avatar, named "XAIA," and a VR environment to deliver immersive and personalized mental health support in mixed-reality environments.

This is a mixed method study with primarily a qualitative focus. Patients with IBD who self-report mild to moderate levels of anxiety or depression will be invited to try a single AI-VR mental health support session using the XAIA app. Participant observations, experiences, and opinions of the application will be collected through surveys and semi-structured interviews. Pre- and post- session pain and state anxiety scores will be collected.

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

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