VR Therapies for IBD
Not applicable · Testing Distraction VR and VR/AI CBT · 2 sites · Brennan Spiegel
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Distraction VR (a device) and VR/AI CBT (a device) as a possible treatment. Condition(s) listed: Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC) and Crohn Disease (CD).
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Stated willingness to comply with all study procedures, VR therapy regimen, and availability for the duration of the study
- Age of 18 years or older
- Confirmed diagnosis of IBD with concurrent anxiety, defined as a GAD-7 score of ≥10
Plus 2 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 76 participants are expected to take part.
- Start date: 2026-06 (planned).
- Main results expected around 2027-06 (estimate from the record).
- 2 study sites listed in United States.
Main thing being measured
- Generalized Anxiety Disorder-7 (GAD-7) (Bi-weekly; Baseline through Week 8)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Crohn Disease (CD); Anxiety |
| Lead sponsor | Brennan Spiegel |
| Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Chicago |
| Enrollment | 76 (estimated) |
| Start date | 2026-06 |
| Primary completion (est.) | 2027-06 |
| First posted | 2026-05-15 |
| Last updated | 2026-05-15 |
| Official title | AI-Enhanced Virtual Reality Cognitive Behavioral Therapy to Reduce Anxiety and Improve Quality of Life in Patients With Inflammatory Bowel Disease: A Multicenter Pilot and Feasibility Study |
| ClinicalTrials.gov ID | NCT07590518 |
Interventions
- Distraction VR (Device)
Distraction-based VR program with 2D nature videos to be used for 8-weeks for 10-20 minutes per week. - VR/AI CBT (Device)
8-week protocolized VR/AI CBT program
Full eligibility criteria (from the record)
Inclusion Criteria: * Stated willingness to comply with all study procedures, VR therapy regimen, and availability for the duration of the study * Age of 18 years or older * Confirmed diagnosis of IBD with concurrent anxiety, defined as a GAD-7 score of ≥10 * 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. 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 * Have cognitive impairments that would affect protocol participation. * Currently engaged in psychotherapy (Patients who are taking medications for anxiety or have previously engaged in psychotherapy but are not currently in therapy will remain eligible). * Have had an IBD related surgery (including perianal surgery) within the past 6 months or anticipated in the next 6 months * Anticipated to change their IBD inflammatory treatment during the study period.
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles, California | United States | |
| University of Chicago | Chicago, Illinois | United States |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.