Outcomes for a digital prescription mobile application for adults with irritable bowel syndrome: an uncontrolled trial

Background Behavioral therapies are effective in the management of irritable bowel syndrome (IBS). Mahana™ IBS is a mobile phone application designed to deliver 10 sessions (10-12 weeks) of gut-directed cognitive behavioral therapy (CBT) to adults with IBS. Objectives To evaluate patient compliance with the Mahana™ mobile phone CBT application and the change in gastrointestinal and psychological symptoms in a real-world UK setting. Methods This single-center prospective study recruited adults with Rome IV IBS from a tertiary care outpatient setting. At baseline and 12-week follow-up, patients completed questionnaires assessing gastrointestinal symptoms (IBS symptom severity scale [IBS-SSS]), depression (patient health questionnaire-9 [PHQ-9]), and anxiety (generalized anxiety disorder-7 [GAD-7]). Results Thirty patients (20/30 female, mean [SD] age 44.57 [14.70]) consented to treatment and completed pre-intervention questionnaires, among whom 20 (66.7%) provided follow-up questionnaire data. Among the 20 individuals with two-point data, there was a statistically significant reduction in the IBS-SSS (P<0.001), GAD-7 (P=0.02), and PHQ-9 (P=0.04) scores. Fourteen (70%) patients reported a clinically significant improvement (≥50 point reduction) in the IBS-SSS; these individuals tended to be older (P=0.04) and male (P=0.04). Patients with IBS-diarrhea reported the greatest improvement in the IBS-SSS versus those with IBS-constipation and IBS-mixed subtypes. The baseline IBS-SSS (P=0.35), GAD-7 (P=0.19) and PHQ-9 (P=0.19) scores were not significantly different between persons who completed the entire CBT intervention versus those who did not. Conclusion This study provides preliminary evidence that the Mahana™ IBS CBT application is associated with a statistically significant improvement in gastrointestinal and psychological symptoms in a real-world UK clinical setting. Trial registration This trial was registered on ClinicalTrials.gov (trial registration number: NCT07008404) on 6 June 2025