Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease

The University of Chicago

Status

Enrolling

Conditions

Ulcerative Colitis

Depression

Anxiety

Inflammatory Bowel Diseases

Crohn Disease

Treatments

Behavioral: Mental health support session

Study type

Interventional

Funder types

Other

Identifiers

NCT06575660

IRB24-0605

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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