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

December 4, 2025 updated by: Melissa Hunt, PhD, University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

453

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-6018
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Treatment - Zemedy App
Participants will be given immediate access to the Zemedy app for IBS.
Behavioral: Zemedy App
Digital smart phone app that delivers cognitive-behavioral therapy for IBS
Active Comparator: 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.
Behavioral: Zemedy App
Digital smart phone app that delivers cognitive-behavioral therapy for IBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Irritable Bowel Syndrome Quality of Life (IBSQoL)
Time Frame: 8 weeks
IBS specific health related quality of life measure. Scale scores range from 0-100 with higher scores reflecting more impairment (worse outcome)
8 weeks
Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: 8 weeks
Gastrointestinal Symptom Rating Scale. Scale scores range from 0-78 with high scores representing worse GI symptoms.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GI-Cognitions Questionnaire (GICog)
Time Frame: 8 weeks
Scale measures distorted, catastrophic beliefs about the social and occupational implications of having gastrointestinal symptoms. Scale scores range from 0 to 64 with higher scores representing worse outcomes (more distorted, catastrophic beliefs about GI symptoms)
8 weeks
Visceral Sensitivity Index (VSI)
Time Frame: 8 weeks
Scale measures anxiety about visceral (gut) sensations. Scale scores range from 0 to 75 with higher scores representing more anxiety.
8 weeks
Fear of Food Questionnaire (FFQ)
Time Frame: 8 weeks
Scale measures fear of food and aversive consequences of eating. Scale scores range from 0-90 with higher scores representing more fear and impairment.
8 weeks
Beck Depression Inventory (BDI)
Time Frame: 8 weeks
Measures depressive symptoms. Scale scores range from 0 to 63 with higher scores representing more severe depressive symptoms.
8 weeks
Work Productivity and Activity Impairment (WPAI)
Time Frame: 8 weeks
Measures occupational impairment stemming from a health condition. scores range from 0 to 30 with higher scores representing more impairment
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Bold Health Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

May 28, 2024

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 844160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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