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OpenTrials
Completed

NCT Number: NCT04665271

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6018, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zemedy App

Behavioral

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

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Bold Health Inc.

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 11, 2020
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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