Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT06575660
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:
NCT06575660
Study Brief:
Protocol Section:
NCT06575660