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Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zemedy App for Irritable Bowel Syndrome
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring cognitive behavioral therapy, self-help, irritable bowel syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate Treatment

Waitlist Control

Arm Description

Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace.

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.

Outcomes

Primary Outcome Measures

Irritable Bowel Syndrome Quality of Life
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
a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome.

Secondary Outcome Measures

Visceral Sensitivity Index
self-report measure of anxiety specific to visceral sensations. Scores range from 0 to 75. Higher scores are a worse outcome.
GI Cognitions Questionnaire
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
self-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome.
Patient Health Questionnaire
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
Self-report measure of depressive symptoms. Scores ranges from 0 to 42. Higher scores represent worse outcome.
Depression Anxiety and Stress Scale - Stress Subscale
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
Measures affective and physical symptoms of anxiety. Scores range from 0-42 with higher scores representing worse anxiety.

Full Information

First Posted
November 14, 2019
Last Updated
January 28, 2021
Sponsor
University of Pennsylvania
Collaborators
Bold Health Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04170686
Brief Title
Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome
Official Title
Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 28, 2019 (Actual)
Primary Completion Date
September 28, 2020 (Actual)
Study Completion Date
September 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Bold Health Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
cognitive behavioral therapy, self-help, irritable bowel syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Treatment
Arm Type
Experimental
Arm Description
Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Zemedy App for Irritable Bowel Syndrome
Intervention Description
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 Outcome Measure Information:
Title
Irritable Bowel Syndrome Quality of Life
Description
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.
Time Frame
8 weeks
Title
Gastrointestinal Symptom Rating Scale
Description
a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Visceral Sensitivity Index
Description
self-report measure of anxiety specific to visceral sensations. Scores range from 0 to 75. Higher scores are a worse outcome.
Time Frame
8 weeks
Title
GI Cognitions Questionnaire
Description
self-report measure of catastrophizing specific to GI symptoms. Scores range from 0 to 64. Higher scores are a worse outcome.
Time Frame
8 weeks
Title
Fear of Food Questionnaire
Description
self-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome.
Time Frame
8 weeks
Title
Patient Health Questionnaire
Description
self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome.
Time Frame
8 weeks
Title
Depression Anxiety and Stress Scale - Depression Subscale
Description
Self-report measure of depressive symptoms. Scores ranges from 0 to 42. Higher scores represent worse outcome.
Time Frame
8 weeks
Title
Depression Anxiety and Stress Scale - Stress Subscale
Description
The stress subscale measures emotional reactivity to perceived stress. Scores range from 0-42 with higher scores representing worse stress reactivity.
Time Frame
8 weeks
Title
Depression Anxiety and Stress Scale - Anxiety Subscale
Description
Measures affective and physical symptoms of anxiety. Scores range from 0-42 with higher scores representing worse anxiety.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa G Hunt, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-6018
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33872182
Citation
Hunt M, Miguez S, Dukas B, Onwude O, White S. Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 May 20;9(5):e26152. doi: 10.2196/26152.
Results Reference
derived

Learn more about this trial

Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

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