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Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

Not Applicable
Completed
Conditions
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
146
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Irritable Bowel Syndrome Quality of Life8 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 Scale8 weeks

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

Secondary Outcome Measures
NameTimeMethod
Visceral Sensitivity Index8 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 Questionnaire8 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 Subscale8 weeks

Measures affective and physical symptoms of anxiety. Scores range from 0-42 with higher scores representing worse anxiety.

GI Cognitions Questionnaire8 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 Subscale8 weeks

Self-report measure of depressive symptoms. Scores ranges from 0 to 42. Higher scores represent worse outcome.

Depression Anxiety and Stress Scale - Stress Subscale8 weeks

The stress subscale measures emotional reactivity to perceived stress. Scores range from 0-42 with higher scores representing worse stress reactivity.

Patient Health Questionnaire8 weeks

self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome.

Trial Locations

Locations (1)

University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States

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