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Behavioral Intervention

VR Therapy for Irritable Bowel Syndrome

N/A

Waitlist Available

Led By Christopher V Almario, MD, MSHPM

Research Sponsored by Christopher Almario

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Must not have

Has cognitive impairment that would affect protocol participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4 and week 8

Summary

This trial aims to test if using virtual reality therapy can help reduce abdominal pain and improve overall functioning in patients with irritable bowel syndrome.

Who is the study for?

This trial is for individuals with significant abdominal pain from IBS, who can read/write English, own a compatible smartphone or computer with internet access. Excluded are those with conditions affecting VR use (like seizures), other GI disorders that could be confused with IBS, opioid medication users, previous VR/CBT trial participants, and those with cognitive impairments.

What is being tested?

The study tests if VR-based cognitive behavioral therapy can reduce abdominal pain in IBS patients compared to sham VR. Participants will randomly receive either the actual VR CBT program or a placebo-like version without therapeutic content.

What are the potential side effects?

Since this trial involves non-invasive virtual reality therapy and not drugs, side effects may include discomfort from wearing the headset or motion sickness but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience significant abdominal pain.

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I have been diagnosed with IBS according to Rome IV criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cognitive issues that may affect my ability to follow study procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4 and week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4 and week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 and week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PROMIS Abdominal Pain Severity

Secondary study objectives

IBS Quality of Life (IBS-QOL)

IBS-Symptom Severity Scale (IBS-SSS)

Other study objectives

NIH PROMIS Anxiety

NIH PROMIS Depression

Visceral Sensitivity Index (VSI)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SynerGIExperimental Treatment1 Intervention

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.

Group II: Sham VRPlacebo Group1 Intervention

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.

0 / 3Eligibility criteria met