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

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT06910787
• Lead Sponsor: University of Michigan

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Study First Posted: 2025-04-04
• Study Start: 2025-04-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-07
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility defined by the proportion of enrolled participants that complete the 4-week VR-directed BGBT program and study assessments.	4 weeks	The study team hypothesizes the study will achieve greater than 75% program completion and 75% study assessment completion.
VR-BGBT acceptability using the Treatment Acceptability and Adherence Scale	4 weeks	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.
VR-BGBT usability using the System Usability Scale	4 weeks	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.
Acceptability of VR-directed BGBT based on a semi-structured post intervention interview	4 weeks	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States