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

NCT06575660 | Completed

• 1 other identifier: IRB24-0605
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Inflammatory Bowel Diseases; Anxiety; Depression; Ulcerative Colitis; Crohn Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• To assess change in pain scores pre- and post-session

  Day 1 pre-session; Day 1 post-session

• To assess change in mood scores pre- and post-session

  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

  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

  Day 1 post-session

Study Arms (1)

Patients with IBD who self-report mild to moderate levels of anxiety or depression

EXPERIMENTAL

Behavioral: Mental health support session

Interventions

Mental health support session BEHAVIORAL

a single AI-VR mental health support session using the XAIA application

Patients with IBD who self-report mild to moderate levels of anxiety or depression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Anxiety Disorders; Depression; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Colitis; Colonic Diseases

Study Officials

• David T Rubin, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: September 23, 2024
• Primary Completion: October 9, 2025
• Study Completion: October 9, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)