Virtual Reality Therapy for Inflammatory Bowel Disease

Not yet recruiting at 1 trial location
KK
SE
Overseen BySamuel Eberlein, MSHS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brennan Spiegel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Through a pilot randomized controlled trial (RCT), the aim is to test the clinical impact and feasibility of a AI-enhanced Virtual Reality (VR) Cognitive Behavioral therapy (CBT) program versus distraction VR among patients with inflammatory bowel disease (IBD) and anxiety. It is hypothesized that using VR/AI CBT may reduce anxiety and IBD symptoms, leading to improved overall physical, psychological, and social functioning when compared to distraction VR.

Who Is on the Research Team?

BS

Brennan Spiegel, MD, MSHS

Principal Investigator

Cedars-Sinai Medical Center

DR

David Rubin, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for people diagnosed with inflammatory bowel disease (like Crohn's or ulcerative colitis) who also experience anxiety. Participants should be able to use virtual reality technology and meet any other basic health requirements set by the study.

Inclusion Criteria

I am willing and able to follow all study procedures and attend all study visits.
Ability to read and write in English (VR/AI CBT program is currently only available in English)
Access to an internet-enabled device (android or iOS smartphone, or personal laptop or desktop computer) to complete surveys and has access to internet and email complete baseline and assessment surveys.
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Exclusion Criteria

Have a condition that interferes with the safe use of VR usage, such as history of seizures, facial injuries precluding headset placement, significant visual or hearing impairment that impacts ability to see the VR images or follow audio instructions
I expect my IBD treatment to change during the study.
I have had or will have IBD surgery within 6 months.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week VR/AI CBT program or distraction VR therapy

8 weeks
Bi-weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • VR/AI CBT

Trial Overview

The study compares two types of virtual reality therapy: one uses AI-enhanced VR cognitive behavioral therapy (CBT), and the other uses distraction-based VR. Patients are randomly assigned to either group to see which helps more with anxiety and IBD symptoms.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: VR/AI CBTExperimental Treatment1 Intervention
Group II: Distraction VRPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brennan Spiegel

Lead Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

University of Chicago

Collaborator

Trials
1,086
Recruited
844,000+