University of Chicago
Chicago, Illinois, 60637, United States
NCT Number: NCT06575660
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60637, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a single AI-VR mental health support session using the XAIA application
Time frame: Day 1 post-session
Measured via a post-session, semi-structured interview
Time frame: Day 1 post-session
Measured by proportion of subjects with at least one adverse event
Time frame: Day 1 post-session
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..."
Time frame: Day 1 pre-session; Day 1 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).
Time frame: Day 1 pre-session; Day 1 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).
Time frame: Day 1 post-session
Measured via a post-session, semi-structured interview
Time frame: Day 1 post-session
Measured via a post-session, semi-structured interview
University of Chicago
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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