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Outpatient VR (Virtual Reality)-Brain-gut Behavioral Therapies (BGBT) in Inflammatory Bowel Disease (IBD)

NCT06910787 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-23

No results posted yet for this study

Summary

This research study is being done to learn if a virtual reality (VR)-directed BGBT program is feasible and acceptable for patients to enhance pain treatment for patients with IBD.

The study hypothesis include:

* the study will achieve greater than 75% program completion and 75% study assessment completion
* patients with IBD will find VR-directed BGBT acceptable as an outpatient pain treatment
* outpatient VR-directed BGBT in IBD arm participants will report a greater reduction in pain scores, symptom burden, stress, depression, anxiety, and pain-related interference and an improvement in health-related quality of life
* will have lower opioid requirements and healthcare utilization at 4-weeks follow-up compared to the E-TAU arm

Conditions

  • Inflammatory Bowel Diseases

Interventions

DEVICE

VR-directed BGBT

VR-directed BGBT using the Oculus Meta Quest 3 VR headset will be delivered using the Synergi application. The program includes 4-weeks of daily self-led activities using 5 virtual modules: (1) education (2) two interactive games (3) breathing exercises (4) gut-directed meditation and (5) gastroenterology-specific Cognitive behavioral therapy (CBT). Participants will also receive standard care. On day 1, intervention arm participants will undergo a brief in-person or virtual (i.e., zoom or Microsoft teams) training with study staff to learn how to use the VR headset and access intervention modules. On day 1 participants will be asked to explore each of the program modules to achieve initial familiarity. Participants will be encouraged to use the VR-BGBT program for at least 15 minutes daily, but at minimum 3-4 days each week. Additionally, study assessments will be completed at baseline, 2-weeks, 4-weeks, and 8-weeks, with an interview within 1-2 weeks of completing the program.

OTHER

E-TAU

Participants will receive standard of care, as directed by the participant's gastroenterologist. Participants will also receive an educational video and fact sheet on pain in IBD. This will be 4-weeks with study assessments at baseline, 2-weeks, and 4-weeks, 8-weeks.

Sponsors & Collaborators

Principal Investigators

  • Shirley Cohen-Mekelburg, MD, MS · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-29
Primary Completion
2026-05-31
Completion
2027-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06910787 on ClinicalTrials.gov