Viewing Study NCT06575660



Ignite Creation Date: 2024-10-26 @ 3:39 PM
Last Modification Date: 2024-10-26 @ 3:39 PM
Study NCT ID: NCT06575660
Status: RECRUITING
Last Update Posted: None
First Post: 2024-08-26

Brief Title: Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease
Sponsor: None
Organization: None

Study Overview

Official Title: Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None