RCT of VR Therapy for IBS

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Randomized Controlled Trial of Virtual Reality Therapies for Irritable Bowel Syndrome

RCT of VR Therapy for IBS

Condition
IBS - Irritable Bowel Syndrome
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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
  • * Presents with a condition that interferes with VR usage, including history of seizure, facial injury precluding safe placement of headset, significant visual or hearing impairment that impacts ability to see the VR images or follow audio instructions
  • * Has cognitive impairment that would affect protocol participation
  • * Has a comorbid disorder that may confound the diagnosis of IBS, including celiac disease, inflammatory bowel disease, autoimmune disorders that affect the GI system, history of bowel resection, HIV/AIDS, diabetes with HgA1c \>=7.0, neuroendocrine tumors, microscopic colitis, eosinophilic bowel disease, acute intermittent porphyria, or any other condition that a physician believes can mimic IBS symptoms and undermine diagnostic certitude
  • * Takes standing doses of opioid medications given the often severe impact of opioids on 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

Ages Eligible for Study

10 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Christopher Almario,

Christopher V Almario, MD, MSHPM, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

2026-06-30