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

NCT ID: NCT06910787

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-29
• Study Completion Date: 2027-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR-directed BGBT

Group Type: EXPERIMENTAL

VR-directed BGBT

Intervention Type: 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.

Enhanced treatment as usual (E-TAU)

Group Type: ACTIVE_COMPARATOR

E-TAU

Intervention Type: 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.

Interventions

VR-directed BGBT

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.

Intervention Type: DEVICE

E-TAU

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Gastroenterological Association

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Shirley Cohen-Mekelburg

Assistant Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley Cohen-Mekelburg, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shirley Cohen-Mekelburg, MD, MS

Role: CONTACT

shcohen@med.umich.edu

734-845-5735

Facility Contacts

Shirley Cohen-Mekelburg

Role: primary

shcohen@med.umich.edu

734-845-5735

Other Identifiers

HUM00267700

Identifier Type: -

Identifier Source: org_study_id