RCT of VR Therapy for IBS

NCT06687616 | Completed FDA Device

• 2 other identifiers: STUDY3343R01DK140676
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

IBS - Irritable Bowel Syndrome

Keywords

Virtual Reality; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• PROMIS Abdominal Pain Severity

  Abdominal pain severity as measured by the 5-item PROMIS Abdominal Pain Severity scale. The scale is rendered using a T-statistic, where a score of 50 represents the population mean and 10 points is a SD.

  Weekly; Baseline through Week 8

Secondary Outcomes (2)

• IBS-Symptom Severity Scale (IBS-SSS)

  Baseline, Week 4 and Week 8

• IBS Quality of Life (IBS-QOL)

  Baseline, Week 4 and Week 8

Other Outcomes (3)

• Visceral Sensitivity Index (VSI)

  Baseline, Week 4 and Week 8

• NIH PROMIS Depression

  Baseline, Week 4 and Week 8

• NIH PROMIS Anxiety

  Baseline, Week 4 and Week 8

Study Arms (2)

SynerGI

EXPERIMENTAL

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.

Device: SynerGI

Sham VR

SHAM COMPARATOR

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.

Device: Sham VR

Interventions

SynerGI DEVICE

Standardized 8-week CBT program, used for 20-30 minutes per week

SynerGI

Sham VR DEVICE

Distraction-based VR program with 2D nature videos to be used for 8 weeks, 2-2 times a week for 10 minutes

Sham VR

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Christopher Almario: lead

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Christopher V Almario, MD, MSHPM

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: February 26, 2025
• Primary Completion: November 21, 2025
• Study Completion: November 25, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (2)