Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

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

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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)

Contacts and Locations

Locations

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104-6018

Sponsors and Collaborators

University of Pennsylvania

Bold Health Inc.

Investigators

• 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.

More Information

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

Hunt M, Miguez S, Dukas B, Onwude O, White S. The Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-Management of Irritable Bowel Syndrome: a Cross-Over, Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Apr 14. doi: 10.2196/26152. [Epub ahead of print]

• 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
• 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

• 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:

Irritable Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases