Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04170686
• Other study ID #: 833848
• Status: Completed
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: September 28, 2020

Study information

• Verified date: January 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: September 28, 2020
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Bold Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Primary	Gastrointestinal Symptom Rating Scale	a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome.	8 weeks
Secondary	Visceral Sensitivity Index	self-report measure of anxiety specific to visceral sensations. Scores range from 0 to 75. Higher scores are a worse outcome.	8 weeks
Secondary	GI Cognitions Questionnaire	self-report measure of catastrophizing specific to GI symptoms. Scores range from 0 to 64. Higher scores are a worse outcome.	8 weeks
Secondary	Fear of Food Questionnaire	self-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome.	8 weeks
Secondary	Patient Health Questionnaire	self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome.	8 weeks
Secondary	Depression Anxiety and Stress Scale - Depression Subscale	Self-report measure of depressive symptoms. Scores ranges from 0 to 42. Higher scores represent worse outcome.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks