Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS

Study Overview
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Brief Summary
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The purpose of this research is to assess if a new digital app version of a self-help intervention for Irritable Bowel Syndrome (IBS), is an acceptable and effective treatment for improving the overall quality of life in patients with IBS.

Detailed Description
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The aim of the current study is to test the acceptability and efficacy of an updated digital app for IBS patients. The design of the study is experimental. There will be two experimental groups, an immediate treatment group and an active control group. Once consented and enrolled, participants will be randomly assigned to either the immediate treatment group or the active control group by the coin toss feature of random.org. Participants in the immediate treatment group will be able to download the app at no cost. Participants in the control group will be given access to an education and relaxation training control app at no cost to them. At 8 weeks after enrollment, all participants in both groups will receive a battery of follow-up questionnaires (the same that they answered directly after consenting in the beginning of the study as baseline measures). Upon receipt of the 8 week questionnaire data, participants in the control group will be given access to the Zemedy app. After having had access to the app for 8 weeks, control participants will be asked to complete another set of questionnaires. All participants will receive 3 month post-treatment follow-up questionnaires. The research method is experimental, cross over (randomized controlled trial) with a control control. Participation in the study will last approximately 4.5 months, depending on the subjects willingness to participate and rate of completion.

Official Title
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Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Zemedy App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-report of physician diagnosis of IBS. At least 18 years of age. Exclusion Criteria: Severe depression or suicidality Comorbid GI disorder such as inflammatory bowel disease or celiac disease. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Active control with cross-over at post-treatment and three month follow-up
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment - Zemedy App<br>Participants will be given immediate access to the Zemedy app for IBS. | Behavioral: Zemedy App<br>* Digital smart phone app that delivers cognitive-behavioral therapy for IBS<br>|
| Active Comparator: Active Control - Education and Relaxation Training App<br>Participants will be given access to a education and relaxation training app. After 8 weeks they will then be crossed over to the Zemedy app. | Behavioral: Zemedy App<br>* Digital smart phone app that delivers cognitive-behavioral therapy for IBS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritable Bowel Syndrome Quality of Life (IBSQoL) | IBS specific health related quality of life measure. Scale scores range from 0-100 with higher scores reflecting more impairment (worse outcome) | 8 weeks | 
| Gastrointestinal Symptom Rating Scale (GSRS) | Gastrointestinal Symptom Rating Scale. Scale scores range from 0-78 with high scores representing worse GI symptoms. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI-Cognitions Questionnaire (GICog) | Scale measures distorted, catastrophic beliefs about the social and occupational implications of having gastrointestinal symptoms. Scale scores range from 0 to 64 with higher scores representing worse outcomes (more distorted, catastrophic beliefs about GI symptoms) | 8 weeks | 
| Visceral Sensitivity Index (VSI) | Scale measures anxiety about visceral (gut) sensations. Scale scores range from 0 to 75 with higher scores representing more anxiety. | 8 weeks | 
| Fear of Food Questionnaire (FFQ) | Scale measures fear of food and aversive consequences of eating. Scale scores range from 0-90 with higher scores representing more fear and impairment. | 8 weeks | 
| Beck Depression Inventory (BDI) | Measures depressive symptoms. Scale scores range from 0 to 63 with higher scores representing more severe depressive symptoms. | 8 weeks | 
| Work Productivity and Activity Impairment (WPAI) | Measures occupational impairment stemming from a health condition. scores range from 0 to 30 with higher scores representing more impairment | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavioral therapy