NCT04133519

Efficacy and Safety of IBS Digital Behavioral Treatment

The Efficacy and Safety of IBS Digital Behavioral Treatment Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: metaMe Health · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Two Self-administered behavioral treatments for Adult Subjects with Symptomatic Irritable Bowel Syndrome (IBS).

Detailed description

EASITx is a pivotal study comparing two self-administered behavioral treatments for irritable bowel syndrome (IBS). The active treatment in EASITx is classified as Software as a Medical Device (SaaMD).

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DEVICE	Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD)	The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment.
DEVICE	Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)	The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks.

Timeline

• Start date: 2019-10-23
• Primary completion: 2020-10-28
• Completion: 2021-10-26
• First posted: 2019-10-21
• Last updated: 2022-05-04
• Results posted: 2022-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study