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Behavioral Intervention
Digital Support for Inflammatory Bowel Disease
N/A
Recruiting
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)
Must not have
Self-reported history of severe motion sickness
Unable to understand the instructions or to consent to participation in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 pre-session; day 1 post-session
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using a digital wellness app with artificial intelligence and virtual reality can provide mental health support to patients with inflammatory bowel disease and mild to moderate anxiety or depression. The study will assess
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 belowSelect...
I am 18 years old or older.
Select...
I have Inflammatory Bowel Disease (either Crohn's or Ulcerative Colitis).
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a severe history of getting motion sickness.
Select...
I can understand the study instructions and agree to participate.
Select...
I am legally blind or deaf.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 pre-session; day 1 post-session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 pre-session; day 1 post-session
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,053 Previous Clinical Trials
759,031 Total Patients Enrolled
3 Trials studying Anxiety
5,886 Patients Enrolled for Anxiety
Cedars-Sinai Medical CenterOTHER
511 Previous Clinical Trials
163,276 Total Patients Enrolled
4 Trials studying Anxiety
282 Patients Enrolled for Anxiety
David T Rubin, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
64 Total Patients Enrolled
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