Will a CBT Smartphone App Perform Better than a Sham App in Improving Quality of Life for people with IBS?
Irritable Bowel Syndrome (IBS) is a chronic gastrointestinal (GI) disorder, characterized primarily by abnormal centralized pain processing and altered bowel habits. IBS has high rates of psychiatric comorbidity, and impairs health-related quality of life (HRQL) and functioning. Cognitive Behavioral Therapy (CBT) has been proven to be an effective treatment for IBS, but access to this treatment remains low due to its high cost and a lack of clinicians able to provide GI-specific CBT. Our proposed solution is a CBT-based smartphone app, Zemedy.
The RCT for Version 1.0 of the Zemedy app showed promising results, reducing IBS symptom severity and improving HRQL. However, users reported low engagement and problems with the app’s overall flow. Version 2.0 is designed to fix the issues reported in the previous study by condensing the modules, fixing bugs, and utilizing entertaining animations. The RCT for Version 2.0 of the Zemedy app utilizes an active control sham app, which is more robust than the waitlist control design used in the previous study. After completing baseline questionnaires, participants are allocated to either the immediate treatment (Zemedy) condition or to the active control condition. The active control condition is an educational and relaxation app meant to simulate treatment as usual for IBS patients. After 8 weeks, both groups will be surveyed again, and the active control group will be given access to Zemedy. After another 8 weeks, the participants who crossed over to the Zemedy app will be surveyed once more. Follow-up questionnaires will be administered at 3, 6, and 12 months post-treatment. Analysis will include intent to treat between-groups comparisons, controlling for baseline symptom severity.
We hypothesize that the Zemedy app will outperform the active control app in reducing IBS symptom severity and improving HRQL.