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Behavioral Intervention

Digital Self-Help App for Irritable Bowel Syndrome

N/A

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-report of physician diagnosis of IBS.

At least 18 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial will test a new digital app version of a self-help intervention for Irritable Bowel Syndrome (IBS) to see if it is an acceptable and effective treatment for improving the overall quality of life in patients with IBS.

Who is the study for?

This trial is for adults over 18 with a doctor's diagnosis of Irritable Bowel Syndrome (IBS). It's not suitable for pregnant individuals, those with severe depression or thoughts of suicide, or anyone with other gastrointestinal conditions like inflammatory bowel disease or celiac disease.Check my eligibility

What is being tested?

The study is testing the Zemedy App, a new digital self-help tool designed to improve quality of life for people with IBS. The app will be compared to an education and relaxation training app to evaluate its acceptability and effectiveness.See study design

What are the potential side effects?

Since this trial involves the use of digital apps rather than medication, traditional side effects are not expected. However, users may experience discomfort if they find the content unhelpful or stressful.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with IBS by a doctor.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gastrointestinal Symptom Rating Scale (GSRS)

Irritable Bowel Syndrome Quality of Life (IBSQoL)

Secondary outcome measures

Beck Depression Inventory (BDI)

Fear of Food Questionnaire (FFQ)

GI-Cognitions Questionnaire (GICog)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate Treatment - Zemedy AppExperimental Treatment1 Intervention

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

Group II: Active Control - Education and Relaxation Training AppActive Control1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,879,788 Total Patients Enrolled

2 Trials studying Irritable Bowel Syndrome

761 Patients Enrolled for Irritable Bowel Syndrome

Bold Health Inc.Industry Sponsor

2 Previous Clinical Trials

168 Total Patients Enrolled

2 Trials studying Irritable Bowel Syndrome

168 Patients Enrolled for Irritable Bowel Syndrome

Media Library

Zemedy App (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04665271 — N/A

Irritable Bowel Syndrome Research Study Groups: Immediate Treatment - Zemedy App, Active Control - Education and Relaxation Training App

Irritable Bowel Syndrome Clinical Trial 2023: Zemedy App Highlights & Side Effects. Trial Name: NCT04665271 — N/A

Zemedy App (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04665271 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me if this research program is recruiting new participants at this time?

"That is accurate. The listing on clinicaltrials.gov affirms that this study, which was originally published on March 1st, 2021, is still looking for volunteers. They are hoping to find 300 patients at a single site."

Answered by AI

Recent research and studies

BMJ OpenJournal

Acceptability and Efficacy of the Zemedy App Versus a Relaxation Training and Meditation App for IBS: Protocol for a Randomised Controlled Trial

Hunt, Melissa G, Anika Dalvie, Simay Ipek, and Ben Wasman. 2022. “Acceptability and Efficacy of the Zemedy App Versus a Relaxation Training and Meditation App for IBS: Protocol for a Randomised Controlled Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2021-055014.

clinicaltrials.govStudy

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

Melissa Hunt, PhD 2021. "Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04665271.

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