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Behavioral Intervention

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

N/A
Waitlist Available
Led By David T Rubin, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 18+ years of age
* Patients with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 pre-session; day 1 post-session
Awards & highlights

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.

Who is the study for?
This trial is for outpatients or hospitalized patients with Inflammatory Bowel Disease (IBD), such as Ulcerative Colitis or Crohn's Disease, who also have mild to moderate anxiety or depression. Specific eligibility criteria are not provided.
What is being tested?
The study explores the use of an AI and VR digital wellness app for mental health support sessions in IBD patients. It aims to assess feasibility, safety, acceptability, and potential benefits on physical and psychological symptoms.
What are the potential side effects?
Since this is a non-invasive digital intervention focusing on mental health support through an app, significant side effects are not anticipated. However, specific side effects are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 pre-session; day 1 post-session
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 pre-session; day 1 post-session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the feasibility of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
Determine the patient acceptance of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
Determine the safety of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
Secondary outcome measures
To assess change in mood scores pre- and post-session
To assess change in pain scores pre- and post-session
To characterize any limitations for creating a AI-VR mental health support tool optimally aligned with the needs of patients with IBD
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with IBD who self-report mild to moderate levels of anxiety or depressionExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,019 Previous Clinical Trials
734,615 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
3,850 Patients Enrolled for Ulcerative Colitis
Cedars-Sinai Medical CenterOTHER
504 Previous Clinical Trials
165,873 Total Patients Enrolled
4 Trials studying Ulcerative Colitis
10,150 Patients Enrolled for Ulcerative Colitis
David T Rubin, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
64 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
64 Patients Enrolled for Ulcerative Colitis
~19 spots leftby Sep 2025