AI-Enhanced Virtual Reality Cognitive Behavioral Therapy to Reduce Anxiety and Improve Quality of Life in Patients with Inflammatory Bowel Disease: A Multicenter Pilot and Feasibility Study - PROJECT SUMMARY Anxiety is a common comorbidity in inflammatory bowel disease (IBD), affecting up to 35% of patients, yet current IBD treatments focus primarily on clinical markers of disease activity and do not adequately address the mental health burden. This gap leads to decreased health-related quality of life (HRQoL), poor patient outcomes, and increased healthcare utilization. Despite the prevalence of anxiety in IBD, access to evidence-based treatments such as Cognitive Behavioral Therapy (CBT) is limited, particularly for patients in rural or underserved areas. Virtual reality (VR) and artificial intelligence (AI)-enhanced CBT represents a novel, scalable solution to overcome these barriers, offering a self-administered, immersive therapy experience that is accessible from the patient’s home. This proposal aims to conduct a pilot randomized controlled trial (RCT) to assess the feasibility and clinical impact of an 8-week home-based VR/AI CBT program versus sham VR control in 76 patients with IBD and anxiety. The study will be conducted at two leading IBD centers: Cedars-Sinai and the University of Chicago. Using the NIH-endorsed ORBIT Model for Developing Behavioral Treatments, our VR/AI CBT program has been refined in Phase I, and we are now ready to proceed with Phase IIa/b pilot testing. The program is designed to improve anxiety, HRQoL, and potentially inflammatory biomarkers in IBD patients. The following specific aims will be addressed: ¨Aim 1: Establish the feasibility of using an 8-week VR/AI CBT program in IBD patients with anxiety. ¨Aim 2: Acquire preliminary data on the clinical impact of the VR/AI CBT program compared to sham VR, focusing on improvements in anxiety, HRQoL (measured by IBDQ), and IBD symptoms (measured by PRO2). ¨Aim 3: Acquire exploratory data on the impact of VR/AI CBT on inflammatory biomarkers, specifically serum C-reactive protein (CRP) and fecal calprotectin (fCal). If successful, this pilot study will provide the foundation for a fully powered Phase IIc efficacy trial, advancing the development of scalable, evidence-based mental health interventions in IBD. By addressing both psychological and physiological dimensions of IBD, VR/AI CBT has the potential to significantly improve patient outcomes and fill a critical unmet need in the management of IBD.
