Status:

COMPLETED

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

Lead Sponsor:

University of Chicago

Collaborating Sponsors:

Cedars-Sinai Medical Center

Conditions:

Inflammatory Bowel Diseases

Anxiety

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 i...

Detailed 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 In...

Eligibility Criteria

Inclusion

  • 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

  • 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 a VR 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

Key Trial Info

Start Date :

September 23 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 9 2025

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT06575660

Start Date

September 23 2024

End Date

October 9 2025

Last Update

November 12 2025

Active Locations (1)

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1

University of Chicago

Chicago, Illinois, United States, 60637