Clinical trial NCT06575660: Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease
Official title: Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Anxiety
Depression
Ulcerative Colitis
Crohn Disease
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
First posted: 2024-08-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 18+ 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Determine the feasibility of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
timeFrame: Day 1 post-session
measure: Determine the safety of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
timeFrame: Day 1 post-session
measure: Determine the patient acceptance of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
timeFrame: Day 1 post-session
Secondary outcomes:
measure: To assess change in pain scores pre- and post-session
timeFrame: Day 1 pre-session; Day 1 post-session
measure: To assess change in mood scores pre- and post-session
timeFrame: Day 1 pre-session; Day 1 post-session
measure: To characterize any limitations for creating a AI-VR mental health support tool optimally aligned with the needs of patients with IBD
timeFrame: Day 1 post-session
measure: To characterize any potential future improvements for creating a AI-VR mental health support tool optimally aligned with the needs of patients with IBD
timeFrame: Day 1 post-session
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: David T Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References: