Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Behavioral: Zemedy App for Irritable Bowel Syndrome

• Registration Number: NCT04170686
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-28
• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-20
• Primary Completion: 2020-09-28
• Study Completion: 2020-09-28
• Results First Submitted: 2020-10-26
• Results First Submitted QC: 2020-12-01
• Results First Posted: 2020-12-24
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Diagnosis of IBS. Own a smart phone. Speak English

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Exclusion Criteria

• Under age of consent (18) Diagnosed with another GI disorder (e.g. celiac disease, inflammatory bowel disease)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate Treatment	Zemedy App for Irritable Bowel Syndrome	Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace.

Primary Outcome Measures

Name	Time	Method
Irritable Bowel Syndrome Quality of Life	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	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

Name	Time	Method
Patient Health Questionnaire	8 weeks	self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome.
Visceral Sensitivity Index	8 weeks	self-report measure of anxiety specific to visceral sensations. Scores range from 0 to 75. Higher scores are a worse outcome.
Fear of Food Questionnaire	8 weeks	self-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome.
Depression Anxiety and Stress Scale - Anxiety Subscale	8 weeks	Measures affective and physical symptoms of anxiety. Scores range from 0-42 with higher scores representing worse anxiety.
GI Cognitions Questionnaire	8 weeks	self-report measure of catastrophizing specific to GI symptoms. Scores range from 0 to 64. Higher scores are a worse outcome.
Depression Anxiety and Stress Scale - Depression Subscale	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	8 weeks	The stress subscale measures emotional reactivity to perceived stress. Scores range from 0-42 with higher scores representing worse stress reactivity.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States