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Completion of prescription app-based cognitive behavioral therapy using Mahana IBS significantly reduced symptom severity and perceived stress for patients with irritable bowel syndrome.
A 10-session course of app-delivered cognitive behavioral therapy (CBT) using the digital therapeutic Mahana IBS resulted in a significant reduction in symptom severity and perceived stress for patients with irritable bowel syndrome (IBS), according to findings presented at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting in Vancouver, Canada.1
In the real-world study, IBS symptom severity score (IBS-SSS) went from a mean of 266 (standard deviation [SD], ±103) at baseline to 162 (SD, ±112) after 10 sessions on the Mahana IBS app, marking a significant improvement (P <.001). Perceived stress scale (PSS) started at a baseline of 22 (SD, ±7) and declined to 17 (SD, ±6) after 10 sessions using Mahana IBS, which was also a significant improvement (P <.001).
"We found that across the board, IBS-SSS and its subcomponents as well as perceived stress scores decreased significantly by both week 5 and week 10," lead investigator Mythili Pathipati, MD, from Massachusetts General Hospital, said during a presentation of the results. "In IBS clinical trials, a reduction of 50 points or greater in the IBS-SSS is considered clinically significant, and here the score is reduced by 104 points by week 10. Patients went from moderate severity IBS to mild severity IBS."
IBS is a stress-sensitive disorder, that can often be associated with early adverse life events, making it an ideal candidate for CBT, noted Pathipati. In some cases, she noted, CBT has shown similar efficacy in IBS as pharmacotherapy. The downside to this approach, however, is an overall shortage of GI-specialized psychologists, with surveys from the ACG noting that fewer than 40% of gastroenterologists had access to one of these specialists.2
"These app-based therapies offer real promise and potential," said Pathipati. "Ideally, every person would have in-person one-on-one CBT, but the reality is that we need to democratize these therapies and make them more accessible."
For the analysis, patients were observed who had received a prescription for the Mahana IBS digital therapeutic and for which baseline IBS-SSS scores were available. Data for the study were collected from August 2021 to August 2023, with a total of 843 screened for entrance into the study. Of those examined, 519 were found to be nonadherent to the app and did not complete any of the courses. There were 324 patients identified who were adherent to the app, having completed 5 or more sessions. Of these individuals, 162 finished all 10 sessions.
"Our study had some limitations. Sex and ethnicity data were missing from the start of the collection period. In our data set, some of the variables were transmitted from the pharmacy partners of Mahana, and so because of user privacy reasons, not all variables were able to be transmitted," said Pathipati. "Some of the data we analyzed were from in-app question that patients filled out once they got the prescription."
For patients who completed 5 sessions, the IBS-SSS scores went from 266 (SD, ±103) at baseline to 185 (SD, ±107), suggesting that some adherence could still bring about results. On the PSS, the mean went from 22 (SD, ±7) at baseline to 19 (SD, ±7) after 5 sessions. For the subscores within the IBS-SSS, after 10 sessions, distention had changed by -12 points (P <.001), pain severity by -11 points (P <.001), days with pain by -1 point (P <.001), IBS interference by -27 points (P <.001), and satisfied bowel by -25 (P <.001).
A multivariate regression model was utilized to help predict which patients were most likely to have a clinically meaningful reduction in IBS-SSS. For this assessment, the investigators analyzed those who responded and those who did not across several variables. Those with a higher IBS-SSS at baseline were more likely to have a reduction in symptom severity with CBT. Those in the responding group had a median baseline IBS-SSS of 270 compared with 235 in the no response group (P <.01). Additionally, lower baseline PSS also predicted responders, with a PSS of 22 in the response group vs 23 in the no response group (P <.01).
Of all those included in the study, the researchers completed further multivariate analyses to predict who was most likely to be adherent to the digital prescription. In this assessment, there were 3 main factors that were significantly correlated with adherence to the program: older age (P <.04), HCP referral (P <.01), and payment for the app (P <.01). In the completed group, the average age was 45 years vs 39 years in the group that did not complete (odds ratio [OR], 1.10). In the completed group, 53% paid for the app vs 31% in the group that did not complete (OR, 1.93). The odds ratio for prescription source was 1.48, favoring a prescription from someone's own HCP compared with a Telehealth prescription, Pathipati noted.
"Patients who were older and received a prescription from their own healthcare provider and who paid for the application were more likely to complete the app-based therapy," said Pathipati. "While it may feel surprising that older individuals were more likely to complete the program, the adoption of digital technology by older adults is increasing and it's perceived to improve their everyday lives, making them more likely to adhere to digital programs."
The Mahana IBS app gained its first approval in December 2020, as a prescription-only digital therapeutic to treat IBS. In August 2023, the company entered a distribution and marketing partnership with Bayer, geared around commercializing the Mahana IBS device.3