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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Inflammatory Bowel Diseases; Anxiety; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Behavioral: Mental health support session

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 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with IBD who self-report mild to moderate levels of anxiety or depression	Behavioral: Mental health support session; a single AI-VR mental health support session using the XAIA application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the feasibility of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD	Measured via a post-session, semi-structured interview	Day 1 post-session
Determine the safety of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD	Measured by proportion of subjects with at least one adverse event	Day 1 post-session
Determine the patient acceptance of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD	Measured via Session Rating Scale (SRS V.3.0), which is a visual analogue scale that measures self-reported effective therapeutic relationships. Scores range from 0 to 40, with higher scores indicating more effective relationships. Scores are commonly classified as "any score lower than 36 overall, or 9 on any [of the 4] scale[s], could be a source of concern..."	Day 1 post-session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess change in pain scores pre- and post-session	Measured via Visual Analogue Pain Scale, which is a scale that measures self-reported pain intensity. Scores range from 0-10, with higher scores indicating greater pain intensity. Scores are commonly classified as "no pain" (0), "mild pain" (1-3), "moderate to severe pain" (4-6), "very severe pain" (7-9), "worst possible pain" (10).	Day 1 pre-session; Day 1 post-session
To assess change in mood scores pre- and post-session	Spielberger State-Trait Anxiety Inventory (STAI), which is a tool that measures self-reported anxiety. Scores range from 0-40, with higher scores indicating greater anxiety. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).	Day 1 pre-session; Day 1 post-session
To characterize any limitations for creating a AI-VR mental health support tool optimally aligned with the needs of patients with IBD	Measured via a post-session, semi-structured interview	Day 1 post-session
To characterize any potential future improvements for creating a AI-VR mental health support tool optimally aligned with the needs of patients with IBD	Measured via a post-session, semi-structured interview	Day 1 post-session

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: David T Rubin, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): October 9, 2025
• Study Completion (Actual): October 9, 2025

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Intestinal Diseases; Behavioral Symptoms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Behavior; Anxiety Disorders; Depression; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: IRB24-0605

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No