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

NCT ID: NCT04665271

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2024-05-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate Treatment - Zemedy App

Participants will be given immediate access to the Zemedy app for IBS.

Group Type: EXPERIMENTAL

Zemedy App

Intervention Type: BEHAVIORAL

Digital smart phone app that delivers cognitive-behavioral therapy for IBS

Active Control - Education and Relaxation Training App

Participants will be given access to a education and relaxation training app. After 8 weeks they will then be crossed over to the Zemedy app.

Group Type: ACTIVE_COMPARATOR

Zemedy App

Intervention Type: BEHAVIORAL

Digital smart phone app that delivers cognitive-behavioral therapy for IBS

Interventions

Zemedy App

Digital smart phone app that delivers cognitive-behavioral therapy for IBS

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Self-report of physician diagnosis of IBS.
• At least 18 years of age.

Exclusion Criteria

• Severe depression or suicidality
• Comorbid GI disorder such as inflammatory bowel disease or celiac disease.
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bold Health Inc.

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Melissa Hunt, PhD

Associate Director of Clinical Training

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Hunt MG, Dalvie A, Ipek S, Wasman B. Acceptability and efficacy of the Zemedy app versus a relaxation training and meditation app for IBS: protocol for a randomised controlled trial. BMJ Open. 2022 Jan 17;12(1):e055014. doi: 10.1136/bmjopen-2021-055014.

Reference Type: DERIVED

PMID: 35039299 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

844160

Identifier Type: -

Identifier Source: org_study_id