A Pilot Study of the Real-World Impact of Digital Cognitive Behavioral Therapy for Inflammatory Bowel Disease (COMPASS-IBD) and on Inflammation, Disease Activity, and Healthcare Use

Background: Inflammatory Bowel Disease (IBD) is commonly accompanied by psychological distress, which may worsen disease activity via gut-brain axis mechanisms. Psychological interventions including cognitive behavioural therapy (CBT) seem to reduce distress and inflammation in IBD. However, accessibility to psychological care remains limited. COMPASS-IBD, a digital CBT intervention tailored to IBD, aims to address these gaps. Objectives: This nested exploratory, real-world study (NCT05330299) assessed the effectiveness of COMPASS-IBD in reducing inflammation, disease activity and healthcare use in IBD patients. Additionally, it examined relationships between changes in psychological distress and disease indicators. Methods: Adults with IBD experiencing psychological distress were recruited from a large gastroenterology service, and enrolled in COMPASS-IBD. Disease-related primary outcomes were faecal calprotectin (FCP) and C-reactive protein (CRP) and self-reported disease activity (SRDA). Secondary outcomes included other inflammatory biomarkers (neutrophils, monocytes, lymphocytes, white blood cells (WBC), ferritin), flare frequency, and healthcare usage. The Patient Health Questionnaire-Anxiety and Depression Scale (PHQ-ADS) measured distress. Mixed-effects models evaluated outcomes at baseline, 12-weeks, and 6-months. Results: Sixty-five participants were included. There were significant reductions in CRP ( d range: −0.47- −0.53, P <0.01), but not FCP ( d range: −0.38 to −0.44, P <0.10) or SRDA ( d =−0.28, P =0.08). Significant improvements were observed in WBC and neutrophil counts ( P <0.05), flare frequency ( P <0.01) and psychological distress ( P <0.001). Some types of healthcare usage were reduced ( P <0.05). Associations between distress and primary outcomes were nonsignificant. Conclusions: This pilot suggests COMPASS-IBD may reduce inflammation levels, healthcare use and psychological distress. However, analyses were underpowered. Larger randomized trials are needed to confirm findings, establish cost-effectiveness and explore underlying gut-brain mechanisms.