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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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 details
    Inflammatory Bowel Diseases

NCT06910787

University of Michigan

10 May 2025

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