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RCT of VR Therapy for IBS

NCT06687616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-12-08

No results posted yet for this study

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.

Conditions

  • IBS - Irritable Bowel Syndrome

Interventions

DEVICE

SynerGI

Standardized 8-week CBT program, used for 20-30 minutes per week

DEVICE

Sham VR

Distraction-based VR program with 2D nature videos to be used for 8 weeks, 2-2 times a week for 10 minutes

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

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

    collaborator NIH

  • Christopher Almario

    lead OTHER

Principal Investigators

  • Christopher V Almario, MD, MSHPM · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-26
Primary Completion
2025-11-21
Completion
2025-11-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06687616 on ClinicalTrials.gov