Virtual Reality (VR) -Directed Brain Gut Behavioral Treatment (BGBT) for Inflammatory Bowel Disease (IBD) Inpatients

• ClinicalTrials.gov Identifier: NCT06188793
• Recruitment Status: Recruiting
• First Posted: January 3, 2024
• Last Update Posted: February 16, 2024
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Shirley Cohen-Mekelburg, University of Michigan

Tracking Information

• First Submitted Date: December 18, 2023
• First Posted Date: January 3, 2024
• Last Update Posted Date: February 16, 2024
• Actual Study Start Date: February 13, 2024
• Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 18, 2023): Feasibility of the intervention measured as the frequency (percentage) of enrolled participants that complete the VR-directed BGBT inpatient program [ Time Frame: 3 days of treatment ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 18, 2023)

• Intervention acceptability based on qualitative data and collected from audio-recordings of semi-structured interview [ Time Frame: 1 week (semi-structured interview within 1 week of completion of the intervention) ]
  Patient acceptability will be evaluated through semi-structured interviews within 1 week of completion of the intervention to understand satisfaction, expectations, and experiences with the protocol, including perceived benefits or harms, and barriers to use.
• Acceptability using the System Usability Scale - patients [ Time Frame: Day 3 (post intervention) ]
  This is a 10-item question scale that are answered from a range from strongly agree to strongly disagree. Scores range from 0 to 100 with a higher score indicating greater acceptability.
• Acceptability using the Treatment Acceptance and Adherence Scale- patients [ Time Frame: Day 3 (post intervention) ]
  This is a 10-item question scale that have a range from disagree strongly- agree strongly. Scores range from 10-70 with higher scores indication greater acceptability.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Virtual Reality (VR) -Directed Brain Gut Behavioral Treatment (BGBT) for Inflammatory Bowel Disease (IBD) Inpatients
• Official Title: Evaluation of a Virtual Reality-Directed Brain Gut Behavioral Treatment Inpatient Program for Patients With Inflammatory Bowel Disease

Brief Summary

The research is studying virtual reality (VR)-directed brain-gut behavioral therapy (BGBT) as a pain treatment option for hospitalized patients with inflammatory bowel disease (IBD). This study is being done to learn if VR-directed BGBT is feasible and acceptable for patients with IBD in addressing pain in the hospital setting.

The study hypothesizes that:

• At least 75% of enrolled participants will complete the VR-directed BGBT inpatient program
• Hospitalized patients with IBD will find VR-directed BGBT acceptable as a pain treatment option in the inpatient setting.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Inflammatory Bowel Diseases

Intervention

Device: Virtual reality-directed BGBT

Enrolled participants will receive up to 3-days of VR-directed BGBT through several modules including distraction games, mindfulness meditation, breathing exercises, and cognitive behavioral therapy based coaching. Participants will complete questionnaires at various time points and be asked to complete a semi-structured interview post-intervention.

Study Arms

Experimental: Virtual reality-directed BGBT

Intervention: Device: Virtual reality-directed BGBT

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 18, 2023): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2025
• Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients with Inflammatory Bowel Disease and self-reported pain
• Hospitalized for management of IBD (inpatient medicine services at Michigan Medicine)

Exclusion Criteria:

• Patients that do not report pain
• Anticipated length of hospital stay is less than 72 hours
• Patients that have previously had a seizure, loss of awareness, or other symptoms linked to an epileptic condition
• Patients with binocular vision loss
• Patients with an uncontrolled cardiac condition such as an arrhythmia, coronary artery disease, or neurological/cerebrovascular disease.
• Patients that are currently pregnant

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06188793
• Other Study ID Numbers: HUM00240999
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Shirley Cohen-Mekelburg, University of Michigan
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Michigan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Shirley Cohen-Mekelburg, MD, MS; University of Michigan

• PRS Account: University of Michigan
• Verification Date: February 2024