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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
Sponsor:
Collaborator:
Bold Health Inc.
Information provided by (Responsible Party):
Melissa Hunt, PhD, University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Behavioral: Zemedy App for Irritable Bowel Syndrome Not Applicable

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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.
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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

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)

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6018
Sponsors and Collaborators
University of Pennsylvania
Bold Health Inc.
Investigators
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Principal Investigator: Melissa G Hunt, PhD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Melissa Hunt, PhD, University of Pennsylvania:
Study Protocol  [PDF] November 15, 2019
No Statistical Analysis Plan (SAP) exists for this study.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melissa Hunt, PhD, University of Pennsylvania:
cognitive behavioral therapy
self-help
irritable bowel syndrome
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases