Clinical Impact and Feasibility of Virtual Reality (VR) for Irritable Bowel Syndrome: A Pilot Randomized Controlled Trial Comparing VR Cognitive Behavioral Therapy vs. Sham VR

PROJECT SUMMARY
This proposal aims to conduct a pilot randomized controlled trial (RCT) to test the clinical impact and feasibility
of a virtual reality (VR) cognitive behavioral therapy (CBT) program vs. sham VR among patients with irritable
bowel syndrome (IBS). IBS causes chronic, recurrent abdominal pain and changes in bowel habits and
affects >10% of the US population. It significantly impacts biopsychosocial functioning, and people with IBS
experience health-related quality of life decrements similar to those with diabetes, end-stage renal disease, and
congestive heart failure. While there are many available pharmacologic treatments, most often fall short in
delivering meaningful improvements in IBS symptoms and are commonly limited by side effects. Conversely, as
IBS is a disorder of gut-brain interaction, CBT has been shown to be very effective and safe in IBS and is
endorsed in national guidelines. There is, however, a paucity of CBT-trained clinicians in the US, which markedly
limits patients’ access to this efficacious, well-tolerated therapy. To begin to address this gap, our team
developed a self-administered, home-based VR program—called IBS/VR—that delivers CBT over an 8-week
period to help patients manage their IBS symptoms. In Phase I (Design) of the ORBIT Model for Developing
Behavioral Treatments for Chronic Diseases framework, we developed and refined the program with a
multidisciplinary team (CBT psychologist, gastroenterologist with IBS expertise, psychiatrist, biomedical
visualization specialist, VR programmer, human-centered design expert, and digital health researchers) in
partnership with patients. The 8-week CBT program guides patients through the following essential components:
(i) psychoeducation; (ii) relaxation strategies; (iii) cognitive restructuring; (iv) problem-solving skills; (v) exposure
techniques. In initial qualitative validation testing with 15 patients, they expressed positive perceptions about
using VR for CBT, and all participants said they would recommend IBS/VR to others with IBS. We are now in
Phase II (Preliminary Testing) of the ORBIT Model and propose to test the clinical impact and feasibility of our
VR CBT program vs. sham VR among patients with IBS. In this pilot RCT, we will achieve the following aims:
Aim 1—Acquire preliminary data assessing the clinical impact of an 8-week VR CBT program (IBS/VR) on IBS
symptoms vs. sham VR control; Aim 2—Establish the feasibility of using an 8-week VR CBT program (IBS/VR)
among patients with IBS. If this pilot study demonstrates that the VR CBT program is both feasible and shows
preliminary evidence that it meaningfully improves IBS symptoms at 8 weeks, it will provide a strong platform to
undertake an adequately powered, hypothesis-testing Phase II efficacy trial in a future R01. Moreover, this study
will provide critical information allowing us to further optimize both the VR CBT program and implementation
efforts in clinical workflows prior to the definitive efficacy trial. Given the high prevalence of IBS combined with
the paucity of effective medical therapies and marked shortage of trained CBT practitioners, the development
and validation of novel self-administered, behavioral approaches—such as VR CBT—are sorely needed.

Grant Number: 5R01DK140676-02
NIH Institute/Center: NIH
Principal Investigator: Christopher Almario