S1141 A Randomized Controlled Trial of a Digital Cognitive Behavioral Therapy Application for Irritable Bowel Syndrome

Introduction: Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction with multifactorial pathophysiology that significantly impairs quality of life. Cognitive behavioral therapy (CBT) has demonstrated efficacy for symptom reduction but is limited by access barriers. This study evaluated the efficacy of a CBT-based smartphone application in reducing IBS symptoms compared to treatment as usual (TAU) in a randomized controlled trial. Methods: We conducted a single-blind randomized controlled trial to evaluate the effectiveness of a CBT smartphone application in reducing IBS symptom burden. Adults meeting Rome IV criteria for IBS were randomized 1:1 to receive treatment-as-usual (TAU) or TAU plus an 8-week intervention via a CBT-based smartphone application. The primary outcome was change in IBS Symptom Severity Scale (IBS-SSS) score at 8 weeks. Secondary outcomes included changes in perceived stress (PSQ), work and social adjustment (WSAS), mood (HADS), and IBS-SSS scores at 24 weeks. Outcomes were assessed at baseline, week 8, and week 24. Results: Of 18 enrolled participants (median age 35.5 years, 72% women), 15 completed follow-up. Baseline characteristics were generally balanced between groups, although the CBT app group had significantly higher baseline perceived stress (median PSQ 32 vs 21, P = 0.0167). At week 8, the CBT app group showed a greater median reduction in IBS-SSS score (-108 [IQR -149, -2]) than TAU (-56.5 [IQR -86, -2]), though the difference was not statistically significant (P = 0.479). At week 24, both groups demonstrated sustained symptom improvement, with a larger reduction in the CBT app group (-55 vs -22.5). No significant between-group differences were observed in changes in HADS, PSQ, or WSAS scores. No adverse events were reported. Conclusion: This pilot randomized trial demonstrates that a mobile-delivered CBT program for IBS is both feasible and safe, with clinically meaningful symptom improvements and reduced perceived stress observed over 8 and 24 weeks. Although differences between intervention and control groups did not reach statistical significance, consistent trends favoring the digital intervention support the need for further evaluation in a larger, adequately powered study. Mobile CBT may represent a promising, scalable adjunct to usual care in IBS management.