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

NCT06910787 | Active Not Recruiting FDA Device

• 1 other identifier: HUM00267700
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammatory Bowel Diseases

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Feasibility defined by the proportion of enrolled participants that complete the 4-week VR-directed BGBT program and study assessments.

  The study team hypothesizes the study will achieve greater than 75% program completion and 75% study assessment completion.

  4 weeks

• Acceptability of VR-directed BGBT based on a semi-structured post intervention interview

  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.

  4 weeks

• VR-BGBT acceptability using the Treatment Acceptability and Adherence Scale

  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.

  4 weeks

• VR-BGBT usability using the System Usability Scale

  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.

  4 weeks

Study Arms (2)

VR-directed BGBT

EXPERIMENTAL

Device: VR-directed BGBT

Enhanced treatment as usual (E-TAU)

ACTIVE COMPARATOR

Other: E-TAU

Interventions

VR-directed BGBT DEVICE

VR-directed BGBT using the Oculus Meta Quest 3 VR headset will be delivered using the Synergi application. The program includes 4-weeks of daily self-led activities using 5 virtual modules: (1) education (2) two interactive games (3) breathing exercises (4) gut-directed meditation and (5) gastroenterology-specific Cognitive behavioral therapy (CBT). Participants will also receive standard care. On day 1, intervention arm participants will undergo a brief in-person or virtual (i.e., zoom or Microsoft teams) training with study staff to learn how to use the VR headset and access intervention modules. On day 1 participants will be asked to explore each of the program modules to achieve initial familiarity. Participants will be encouraged to use the VR-BGBT program for at least 15 minutes daily, but at minimum 3-4 days each week. Additionally, study assessments will be completed at baseline, 2-weeks, 4-weeks, and 8-weeks, with an interview within 1-2 weeks of completing the program.

VR-directed BGBT

E-TAU OTHER

Participants will receive standard of care, as directed by the participant's gastroenterologist. Participants will also receive an educational video and fact sheet on pain in IBD. This will be 4-weeks with study assessments at baseline, 2-weeks, and 4-weeks, 8-weeks.

Enhanced treatment as usual (E-TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• American Gastroenterological Association: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Pain

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shirley Cohen-Mekelburg, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Model Details: Participants will be randomized in a 1:1 ratio to Enhanced Treatment as Usual (E-TAU) or VR-directed BGBT

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: April 29, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)