Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease
NCT Number: NCT06575660
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inflammatory Bowel Diseases|Anxiety|Depression|Ulcerative Colitis|Crohn Disease
Interventions: BEHAVIORAL: Mental health support session
Sponsor: University of Chicago
Collaborators: Cedars-Sinai Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2025-09
Locations: University of Chicago, Chicago, Illinois, 60637, United States

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.

Primary Outcome Measures: 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: 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