Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 28, 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pennsylvania
  • Collaborator
    • Bold Health Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Melissa Hunt, PhD, Associate Director of Clinical Training – University of Pennsylvania
  • Overall Official(s)
    • Melissa G Hunt, PhD, Principal Investigator, University of Pennsylvania

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