Clinical trial NCT06910787: Outpatient VR (Virtual Reality)-Brain-gut Behavioral Therapies (BGBT) in Inflammatory Bowel Disease (IBD)
Official title: Outpatient Virtual Reality-Directed Treatment for Pain in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Virtual Reality
Outpatient
Pain
Brain Gut Behavioral Treatment
Enhanced treatment as usual
Randomized
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Gastroenterological Association
First posted: 2025-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in a 1:1 ratio to Enhanced Treatment as Usual (E-TAU) or VR-directed BGBT
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility defined by the proportion of enrolled participants that complete the 4-week VR-directed BGBT program and study assessments.
timeFrame: 4 weeks
measure: Acceptability of VR-directed BGBT based on a semi-structured post intervention interview
timeFrame: 4 weeks
measure: VR-BGBT acceptability using the Treatment Acceptability and Adherence Scale
timeFrame: 4 weeks
measure: VR-BGBT usability using the System Usability Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Shirley Cohen-Mekelburg, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: