NCT04723056

Zemedy Application for Irritable Bowel Syndrome

Zemedy - Evaluation of Zemedy, a Cognitive Behavioral Therapy-based Digital Therapeutic Application for the Treatment of Irritable Bowel Syndrome

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.

Detailed description

Irritable bowel syndrome (IBS) is defined as having recurrent abdominal pain associated with defecation or a change of bowel habits. The pathophysiology of IBS can be looked through the biopsychosocial model of disease which is defined by the complex interplay between genetic, cultural, environmental, and psychosocial factors. Treatment of IBS is multifaceted and ranges from exercise to dietary restrictions, however, psychological treatments to target the gut-brain axis such as cognitive-behavior therapy (CBT) have also been shown to be an effective therapy, and aims to address the psychological and environmental stressors that contribute to the symptoms. Therefore the purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS. CBT has been shown to reduce the severity of intractable IBS symptoms by as much as 70%. The investigators hope to learn whether the Zemedy mobile application is effective in the reduction of IBS. This will be measured based on their IBS Symptom Severity Scores (SSS) at week 8 compared to baseline.

Conditions

• IBS - Irritable Bowel Syndrome

Interventions

Type	Name	Description
DEVICE	Use of Zemedy Application	8 weeks of CBT via the Zemedy Application.

Timeline

• Start date: 2021-10-15
• Primary completion: 2024-03-08
• Completion: 2024-03-08
• First posted: 2021-01-25
• Last updated: 2025-05-28
• Results posted: 2025-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study