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.
