Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome

Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome: A Randomized Trial Comparing Brain-Gut Directed VR vs. Sham VR

In this study, the investigators conduct a remote, eight-week, two-arm, randomized controlled trial that assesses the benefits, primarily measured through the irritable bowel syndrome (IBS)-targeted HRQOL (health-related quality of life), of an immersive, disease-targeted virtual reality program compared to a non-immersive virtual reality program for patients with IBS.

Study Overview

• Status: Withdrawn
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Device: Virtual Reality Headset

Detailed Description

In this study, the investigators will conduct a decentralized, remote, eight-week, two-arm, randomized controlled trial of SynerGI, a disease-targeted, brain-gut directed, immersive VR program for people with IBS, versus sham VR delivered in a VR headset. Eligible participants will be assigned to a study arm using a 1:1 random number generator and will be blinded to allocation. Data analysts will also be blinded to allocation; only pre-specified staff who are uninvolved with data analyses will be unblinded for purposes of study administration (e.g., sending allocation-specific study materials). After completion of the treatment, participants will be invited to participate in an optional 30-minute semi-structured interview to better understand their experiences of VR treatment. Qualitative interviews will be audio-recorded and transcribed.

The primary aim of this study will be to assess the benefits of disease-targeted VR compared to sham VR on clinically relevant outcomes. The second aim will seek to determine patient-level predictors of treatment response to active VR therapy. The third aim will seek to understand patient experiences of VR to better inform the design of VR treatments for digestive diseases in the future.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English-speaking
• 18 years or older
• Meet Rome IV criteria, as diagnosed either by a licensed physician or via self-report using the Rome IBS questionnaire, for IBS for any type: IBS-C (IBS with constipation), IBS-D (IBS with diarrhea), and IBS-M (mixed-type IBS)

Exclusion Criteria:

• Individuals with 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 ( human immunodeficiency virus/acquired immunodeficiency syndrome)
• diabetes with HgA1c>7.0
• neuroendocrine tumors
• microscopic colitis
• lactase deficiency
• eosinophilic bowel disease
• acute intermittent porphyria
• any other condition that a licensed physician believes can mimic IBS symptoms and undermine diagnostic certitude
• Patients using regular doses of opioid medications will also be excluded given the often-severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia
• No WiFi at home
• Any history of seizure
• Ongoing treatment for a GI cancer
• Major audiovisual impairment (complete blindness, deafness)
• Inability to understand English at 6th grade level
• Any events planned over the 8 weeks of the study that could end your ability to participate in the study, such as a medical procedure, vacation, or change in residence (Note: the study team can always delay enrollment)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBS/VR Program (SynerGI)	Device: Virtual Reality Headset; Participants will be mailed a Meta Quest 2 Headset. Participants will be asked to wear and use the VR headset for around 20 minutes each day for 8 weeks.
Sham Comparator: Sham VR Program	Device: Virtual Reality Headset; Participants will be mailed a Meta Quest 2 Headset. Participants will be asked to wear and use the VR headset for around 20 minutes each day for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS-targeted HRQOL (health-related quality of life)	The primary outcome will be an increase in IBS-QOL (quality of life) scores between baseline and week 8 for those on the study arm. Each question is positively scored 1-5, and the sum is normalized into a 0-100 score, with 100 being the highest reported quality of life and 0 being the lowest.	Baseline, after 4 weeks using device, after 8 weeks using device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GI (Gastrointestinal) Pain Intensity	A secondary outcome will be a decrease in PROMIS (Patient Reported Outcomes Measurement Information System) GI Pain scores scored on a scale of 1-5 with 1 being low pain intensity and 5 being high. These scores are summed for a raw score, which may be converted into a T-score.	Baseline, after 4 weeks using device, after 8 weeks using device
IBS symptom severity	A secondary outcome will be a decrease in patient reported IBS Symptom Severity Score (IBS-SSS). Scored on a 0-500 scale.; < 75 points - IBS considered in remission; 75-174 - mild IBS; 175-299 - moderate IBS; 300-500 - severe IBS5 measures# of days with abdominal pain x 10 - maximum score of 1001-100 scale for abdominal pain severity0-100 scale for abdominal distension severity0-100 scale for satisfaction with bowel habits0-100 scale for interference with life'	Weekly for 8 weeks
Visceral anxiety	A secondary outcome will be a decrease in patient reported Visceral Sensitivity Index (VSI) scores. Each question is positively scored 1-6. 1 represents the most visceral anxiety and 6 represents no visceral anxiety. The VSI items then are reversed scored, meaning that the 1-6 becomes 5-0. These reverse scores are then summed. The max score, representing severe visceral anxiety is 75. The minimum score is 0 (no visceral anxiety).	Baseline, after 4 weeks using device, after 8 weeks using device
Generalized anxiety	A secondary outcome will be a decrease in PROMIS (Patient Reported Outcomes Measurement Information System) Anxiety scores. Each question is positively scored 1-5 (meaning that 1 is no anxiety and 5 the highest anxiety), then summed for raw score, which may be converted into a T-Score.	Baseline, after 4 weeks using device, after 8 weeks using device
Maladaptive GI (Gastrointestinal) cognitions	A secondary outcome will be a decrease in patient reported Gastrointestinal Cognitions Questionnaire (GI-COG) scores. Each question is scored positively from 0-4, then summed for raw score. Raw scores 0-19, 20-39, and 40-64 indicate mild catastrophizing, moderate catastrophizing, and severe catastrophizing respectively.	Baseline, after 4 weeks using device, after 8 weeks using device
Somatization	A secondary outcome will be a decrease in patient reported Patient Health Questionnaire (PHQ-15) scores. Each question is positively scored 0-2, then summed for raw score. The total PHQ-15 score ranges from 0 to 30 and scores of ≥5, ≥10, ≥15 represent mild, moderate and severe levels of somatization, respectively.	Baseline, after 4 weeks using device, after 8 weeks using device
Increase in Symptom Relief	A secondary outcome will be an increase in patient reported "Adequate Relief" global assessment. This is a binary outcome (yes or no)	End of Study, which will occur after 8 weeks using device
Optional Individual Cognitive Interviews	Obtaining qualitative feedback from participants in the treatment group about their experiences with the SynerGI software	End of Study, which will occur after 8 weeks using device
Optional Rome IV Criteria assessment	Using the fourth version of the Rome Criteria, potential participants may self-diagnose themselves with IBS.	At screening/baseline

Collaborators and Investigators

• Sponsor: Anthony Lembo
• Collaborators: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Anthony Lembo, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: IBS; Virtual Reality
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Disease; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Syndrome
• Other Study ID Numbers: VR Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No