NCT04665271

Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to assess if a new digital app version of a self-help intervention for Irritable Bowel Syndrome (IBS), is an acceptable and effective treatment for improving the overall quality of life in patients with IBS.

Detailed description

The aim of the current study is to test the acceptability and efficacy of an updated digital app for IBS patients. The design of the study is experimental. There will be two experimental groups, an immediate treatment group and an active control group. Once consented and enrolled, participants will be randomly assigned to either the immediate treatment group or the active control group by the coin toss feature of random.org. Participants in the immediate treatment group will be able to download the app at no cost. Participants in the control group will be given access to an education and relaxation training control app at no cost to them. At 8 weeks after enrollment, all participants in both groups will receive a battery of follow-up questionnaires (the same that they answered directly after consenting in the beginning of the study as baseline measures). Upon receipt of the 8 week questionnaire data, participants in the control group will be given access to the Zemedy app. After having had access to the app for 8 weeks, control participants will be asked to complete another set of questionnaires. All participants will receive 3 month post-treatment follow-up questionnaires. The research method is experimental, cross over (randomized controlled trial) with a control control. Participation in the study will last approximately 4.5 months, depending on the subjects willingness to participate and rate of completion.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Zemedy App	Digital smart phone app that delivers cognitive-behavioral therapy for IBS

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-12-30
• Completion: 2024-05-28
• First posted: 2020-12-11
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States