Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome
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ClinicalTrials.gov Identifier: NCT04170686 |
Recruitment Status :
Completed
First Posted : November 20, 2019
Results First Posted : December 24, 2020
Last Update Posted : February 16, 2021
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Condition or disease | Intervention/treatment | Phase |
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Irritable Bowel Syndrome | Behavioral: Zemedy App for Irritable Bowel Syndrome | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 146 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome |
Actual Study Start Date : | October 28, 2019 |
Actual Primary Completion Date : | September 28, 2020 |
Actual Study Completion Date : | September 28, 2020 |
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.
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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.
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04170686
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-6018 |
Principal Investigator: | Melissa G Hunt, PhD | University of Pennsylvania |
Documents provided by Melissa Hunt, PhD, University of Pennsylvania:
Responsible Party: | Melissa Hunt, PhD, Associate Director of Clinical Training, University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT04170686 |
Other Study ID Numbers: |
833848 |
First Posted: | November 20, 2019 Key Record Dates |
Results First Posted: | December 24, 2020 |
Last Update Posted: | February 16, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
cognitive behavioral therapy self-help irritable bowel syndrome |
Irritable Bowel Syndrome Syndrome Disease Pathologic Processes Colonic Diseases, Functional |
Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |