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

NCT ID: NCT06575660

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2025-10-09

Brief Summary

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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

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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.

Conditions

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Inflammatory Bowel Diseases Anxiety Depression Ulcerative Colitis Crohn Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with IBD who self-report mild to moderate levels of anxiety or depression

Group Type EXPERIMENTAL

Mental health support session

Intervention Type BEHAVIORAL

a single AI-VR mental health support session using the XAIA application

Interventions

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Mental health support session

a single AI-VR mental health support session using the XAIA application

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David T Rubin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB24-0605

Identifier Type: -

Identifier Source: org_study_id