Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

Study Overview
=================
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.

Official Title
-----------------
Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Behavioral: Zemedy App for Irritable Bowel Syndrome


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment<br>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<br>* 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.<br>|
| No Intervention: Waitlist Control<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Patient Health Questionnaire | self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome. | 8 weeks | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive behavioral therapy, self-help, irritable bowel syndrome