CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 378 enrolled
Drug / intervention
Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04133519
NCT04133519N/ACompleted
CompareCT.gov

The Efficacy and Safety of IBS Digital Behavioral Treatment Study

metaMe Health·interventional·Posted Oct 21, 2019·Updated May 4, 2022

In Brief

A clinical study evaluating Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD) and Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) for Irritable Bowel Syndrome. Completed, enrolled 378 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 21, 2019
Enrollment StartOct 23, 2019
Primary CompletionOct 28, 2020
Study CompletionOct 26, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.7 years ago

Interventions

Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD)device

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.

Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)device

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.