RECRUITING

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

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Conditions

Inflammatory Bowel DiseasesVirtual RealityOutpatientPainBrain Gut Behavioral TreatmentEnhanced treatment as usualRandomized

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Outpatient Virtual Reality-Directed Treatment for Pain in Inflammatory Bowel Disease

Quick Facts

Study Start:2025-04-29
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06910787

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * IBD-targeted treatment include 5-aminosalicylates, thiopurines, biologics, or small molecules such as Janus kinase inhibitor (JAK) inhibitors or sphingosine-1-receptor modulators.
  3. * Self-report abdominal pain with an average severity ≥ 2 on a 0-10 pain scale over the last 24 hours,
  4. * Participants are willing and able to pick-up and drop-off VR equipment at University of Michigan (UM)
  1. * Patients that do not report pain (i.e., score\<2) as they are less likely to benefit from VR-directed BGBT
  2. * 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.

Contacts and Locations

Study Contact

Shirley Cohen-Mekelburg, MD, MS
CONTACT
734-845-5735
shcohen@med.umich.edu

Principal Investigator

Shirley Cohen-Mekelburg, MD, MS
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Shirley Cohen-Mekelburg, MD, MS, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-29
Study Completion Date2027-10

Study Record Updates

Study Start Date2025-04-29
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • Virtual Reality
  • Outpatient
  • Pain
  • Brain Gut Behavioral Treatment
  • Enhanced treatment as usual
  • Randomized

Additional Relevant MeSH Terms

  • Inflammatory Bowel Diseases