Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

January 28, 2021 updated by: Melissa Hunt, PhD, University of Pennsylvania
The purpose of this research is to assess if a new self-help app for IBS is an acceptable and effective intervention for improving the overall quality of life in patients with Irritable Bowel Syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of IBS. Own a smart phone. Speak English

Exclusion Criteria:

  • Under age of consent (18) Diagnosed with another GI disorder (e.g. celiac disease, inflammatory bowel disease)

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
Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace.
Behavioral: Zemedy App for Irritable Bowel Syndrome
The Zemedy App for irritable bowel syndrome is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS.
No Intervention: Waitlist Control
Participants in the waitlist will receive no intervention for 8 weeks, other than a few "check in" emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Irritable Bowel Syndrome Quality of Life
Time Frame: 8 weeks
A self-report measure of health related quality of life (HRQL) in people with irritable bowel syndrome. Scores range from 0 to 100. Higher scores are a worse outcome.
8 weeks
Gastrointestinal Symptom Rating Scale
Time Frame: 8 weeks
a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visceral Sensitivity Index
Time Frame: 8 weeks
self-report measure of anxiety specific to visceral sensations. Scores range from 0 to 75. Higher scores are a worse outcome.
8 weeks
GI Cognitions Questionnaire
Time Frame: 8 weeks
self-report measure of catastrophizing specific to GI symptoms. Scores range from 0 to 64. Higher scores are a worse outcome.
8 weeks
Fear of Food Questionnaire
Time Frame: 8 weeks
self-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome.
8 weeks
Patient Health Questionnaire
Time Frame: 8 weeks
self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome.
8 weeks
Depression Anxiety and Stress Scale - Depression Subscale
Time Frame: 8 weeks
Self-report measure of depressive symptoms. Scores ranges from 0 to 42. Higher scores represent worse outcome.
8 weeks
Depression Anxiety and Stress Scale - Stress Subscale
Time Frame: 8 weeks
The stress subscale measures emotional reactivity to perceived stress. Scores range from 0-42 with higher scores representing worse stress reactivity.
8 weeks
Depression Anxiety and Stress Scale - Anxiety Subscale
Time Frame: 8 weeks
Measures affective and physical symptoms of anxiety. Scores range from 0-42 with higher scores representing worse anxiety.
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.

Investigators

  • Principal Investigator: Melissa G Hunt, PhD, University of Pennsylvania

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)

October 28, 2019

Primary Completion (Actual)

September 28, 2020

Study Completion (Actual)

September 28, 2020

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 833848

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

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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