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OpenTrials
Completed

NCT Number: NCT04170686

Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

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

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Zemedy App for Irritable Bowel Syndrome

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Bold Health Inc.

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2019
Registry last updated
Feb 16, 2021

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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