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SynerGI 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 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4 and week 8

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Irritable Bowel Syndrome

Eligibility Criteria

Inclusion Criteria

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

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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, daily treatments last between 5-20 minutes. The VR modules are reinforced with daily messages and CBT exercises delivered by a webapp that is available on any smartphone or computer along with text messages. 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 have daily sessions over the 8-week treatment period and be instructed to watch a video for 5-20 minutes each day.

0 / 4Eligibility criteria met