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

Outpatient Virtual Reality-Directed Treatment for Pain in Inflammatory Bowel Disease

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

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Device: VR-directed BGBT; Other: E-TAU

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adult outpatients (18 years and older) that carry a diagnosis of IBD and confirmed in the electronic health record (EHR) as receiving IBD-targeted treatment
• IBD-targeted treatment include 5-aminosalicylates, thiopurines, biologics, or small molecules such as Janus kinase inhibitor (JAK) inhibitors or sphingosine-1-receptor modulators.
• Self-report abdominal pain with an average severity ≥ 2 on a 0-10 pain scale over the last 24 hours,
• Participants are willing and able to pick-up and drop-off VR equipment at University of Michigan (UM)

Exclusion Criteria:

• Patients that do not report pain (i.e., score<2) as they are less likely to benefit from VR-directed BGBT
• Patients with a history of conditions that could potentially be harmed by VR including seizures/epilepsy, loss of awareness, binocular vision loss, current pregnancy, or uncontrolled cardiac (e.g., arrhythmia, coronary artery disease) or neurological/cerebrovascular disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR-directed BGBT	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.
Active Comparator: Enhanced treatment as usual (E-TAU)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility defined by the proportion of enrolled participants that complete the 4-week VR-directed BGBT program and study assessments.	The study team hypothesizes the study will achieve greater than 75% program completion and 75% study assessment completion.	4 weeks
Acceptability of VR-directed BGBT based on a semi-structured post intervention interview	The interview will be done to understand the participants' experience with the VR-directed BGBT intervention and conducted using interview guides with open-ended questions. interview guides will focus on four main domains related to participant's pain history, experience with VR-directed BGBT (including tolerability and acceptability of each BGBT module), perceived impact (including information on any components that were perceived to be most helpful or ineffective), and suggested improvements for program refinement.	4 weeks
VR-BGBT acceptability using the Treatment Acceptability and Adherence Scale	This is a 10-question scale that participants choose from 1 (disagree strongly) - 7 (agree strongly). Scores range from 10-70 with higher scores indication greater acceptability.	4 weeks
VR-BGBT usability using the System Usability Scale	This is a 10-question scale that participants choose from 1 (strongly agree) - 5 (strongly disagree). Scores range from 0 to 100 with a higher score indicating greater acceptability.	4 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: American Gastroenterological Association
• Investigators: Principal Investigator: Shirley Cohen-Mekelburg, MD, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Outpatient; Randomized; Virtual Reality; Brain Gut Behavioral Treatment; Enhanced treatment as usual
• Additional Relevant MeSH Terms: Neurologic Manifestations; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Inflammatory Bowel Diseases
• Other Study ID Numbers: HUM00267700

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: Yes
• product manufactured in and exported from the U.S.: No