VR Therapies for IBD

Part of paid clinical trials in Los Angeles, California.

Sponsor
Brennan Spiegel
Study ID
NCT07590518
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Crohn Disease (CD)
  • Inflammatory Bowel Disease (IBD)
  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VR/AI CBT
    The VR/AI CBT program will be delivered through the Meta Quest 2 device and is self-administered and includes a network of environments arranged in a virtual clinic that participants experience at home though a protocolized, 8-week program. Depending on the module, experiences within the program last between 10-20 minutes. Participants will be prompted to regularly use the headset each week over the 8-week study period. The VR modules are reinforced with regularly scheduled messages and CBT exercises delivered by a webapp that is available on any smartphone or computer. The program progressively builds new skills and culminates in transitioning from using VR to applying the skills learned in VR to everyday life.
  • Sham Comparator: Distraction VR
    Participants in the distraction VR group will receive the same Meta Quest 2 device but will only have access to a distraction-based VR therapy program that includes 2D nature videos (e.g., relaxing on a beach, swimming with dolphins). Similar to the VR/AI CBT arm, people in the distraction VR group will be prompted to regularly use the headset each week for the 8-week treatment period.

Primary Outcome Measure

Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Bi-weekly; Baseline through Week 8 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Karisma K Suchak, MD, MSHS
[email protected]
310-423-0714
Samuel Eberlein, MSHS
[email protected]
310-423-6721
Brennan Spiegel, MD, MSHS (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Alexandra McDermott
[email protected]
847-409-0284
David Rubin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of Chicago· Chicago, IL

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