RCT of VR Therapy for IBS

Last updated: September 30, 2025
Sponsor: Christopher Almario
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Lactose Intolerance

Colic

Gastrointestinal Diseases And Disorders

Treatment

Sham VR

Sham VR

SynerGI

Clinical Study ID

NCT06687616
STUDY3343
R01DK140676
  • Ages > 10
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 painT-score ≥ 55 (0.5 standard deviation [SD] above the normalized population mean of

  • 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

Exclusion

Exclusion Criteria:

  • Presents with a condition that interferes with VR usage, including history ofseizure, facial injury precluding safe placement of headset, significant visual orhearing impairment that impacts ability to see the VR images or follow audioinstructions

  • Has cognitive impairment that would affect protocol participation

  • Has a comorbid disorder that may confound the diagnosis of IBS, including celiacdisease, inflammatory bowel disease, autoimmune disorders that affect the GI system,history of bowel resection, HIV/AIDS, diabetes with HgA1c >=7.0, neuroendocrinetumors, microscopic colitis, eosinophilic bowel disease, acute intermittentporphyria, or any other condition that a physician believes can mimic IBS symptomsand undermine diagnostic certitude

  • Takes standing doses of opioid medications given the often severe impact of opioidson GI motility and potential for pharmacological visceral hyperalgesia

  • Previously participated in a VR clinical trial

  • Previously participated in talk therapy

  • Previously used a VR program to treat their IBS

Study Design

Total Participants: 72
Treatment Group(s): 4
Primary Treatment: Sham VR
Phase:
Study Start date:
February 26, 2025
Estimated Completion Date:
December 01, 2025

Study Description

A pilot randomized, sham-controlled clinical trial will be conducted in participants with IBS to achieve the following aims: Aim 1-collect preliminary data assessing the clinical impact of VR cognitive behavioral therapy (CBT) (SynerGI); Aim 2-establish the feasibility of using an 8-week VR CBT program among patients with IBS. The study will follow the established NIH protocol for conducting VR clinical trials, which aligns with VR-CORE clinical trial guidance. Participants will be randomized in a 1:1 ratio between two arms : (i) immersive VR CBT Program (SynerGI); and (ii) sham VR. As a pilot randomized controlled trial, it will not be powered for hypothesis testing of clinical outcomes . Instead, the focus will be on determining the plausibility and feasibility of SynerGI, with the aim to recruit 30 fully analyzable patients per arm.

Patients will be randomized 1:1 to each study arm . Block randomization will be implemented, using random permuted block sizes of 6, 8, or 10, allowing for up to 15% additional participants beyond the original sample size to account for dropouts. Randomization will also be stratified by sex to ensure a balance of women and men in each arm. Assessments will take place at baseline, midway through therapy at 4 weeks, and after completing the program at 8 weeks (a standard treatment length for VR trials).

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

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