RecruitingNot ApplicableNCT06910787

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

Sponsor

University of Michigan

Enrollment

40 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel Diseases

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

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria2

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.

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Interventions

DEVICEVR-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.

OTHERE-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.