NCT07590518Not yet recruiting
VR Therapies for IBD
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
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 6 May 2026
- Start date
- Jun 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Brennan Spiegel
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07590518
What you commit to
- Study type: Interventional
- Planned participants: 76
- From Jun 2026 to the primary completion date, Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Have cognitive impairments that would affect protocol participation.
- Anticipated to change their IBD inflammatory treatment during the study period.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.