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

University of Michigan

Status

Enrolling

Conditions

Inflammatory Bowel Diseases

Treatments

Device: VR-directed BGBT

Other: E-TAU

Study type

Interventional

Funder types

Other

Identifiers

NCT06910787

HUM00267700

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.