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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

Award Number: R01DK144719
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/09/2025
PERIOD OF PERFORMANCE END DATE: 06/30/2028

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $332,410 )
2026	2026	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	8/4/2026	NON-COMPETING CONTINUATION	$332,410
														Subtotal = $332,410

Issue Date FY: 2025 ( Subtotal = $349,160 )
2025	2025	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/10/2025	NEW	$349,160
														Subtotal = $349,160

Grand Total All Awards = $681,570

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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

Award Number: R01DK144719

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/09/2025

PERIOD OF PERFORMANCE END DATE: 06/30/2028

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