Randomized Controlled Trial of Virtual Reality Therapies for Irritable Bowel Syndrome

Status: Completed
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Through a pilot randomized controlled trial (RCT), the aim is to test the clinical impact and feasibility of a virtual reality (VR) cognitive behavioral therapy (CBT) program versus sham VR among patients with irritable bowel syndrome (IBS). It is hypothesized that using VR-administered CBT may reduce abdominal pain, leading to improved overall physical, psychological, and social functioning when compared to sham VR.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Healthy Volunteers: f
View:

• Has been diagnosed by a physician with Rome IV IBS; all subtypes will be included

• Has clinically significant abdominal pain as defined as an NIH PROMIS abdominal pain T-score ≥ 55 (0.5 standard deviation \[SD\] above the normalized population mean of 50)

• Able to read/write English (SynerGI is currently only available in English)

• Owns a compatible android or iOS smartphone, or personal laptop or desktop computer (excluding tablets) to complete surveys and has access to internet and email

Locations
United States
California
Cedars-Sinai Medical Center
Los Angeles
Ohio
Cleveland Clinic
Cleveland
Time Frame
Start Date: 2025-02-26
Completion Date: 2025-11-25
Participants
Target number of participants: 73
Treatments
Experimental: SynerGI
The standardized CBT program (SynerGI) 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 5-20 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: Sham VR
Patients in the sham 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 SynerGI arm, people in the sham VR group will be prompted to regularly use the headset each week for the 8-week treatment period.
Related Therapeutic Areas
Sponsors
Leads: Christopher Almario
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Cleveland Clinic

This content was sourced from clinicaltrials.gov