Zemedy Application for Irritable Bowel Syndrome

Study Overview
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Brief Summary
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The purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.

Detailed Description
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Irritable bowel syndrome (IBS) is defined as having recurrent abdominal pain associated with defecation or a change of bowel habits. The pathophysiology of IBS can be looked through the biopsychosocial model of disease which is defined by the complex interplay between genetic, cultural, environmental, and psychosocial factors. Treatment of IBS is multifaceted and ranges from exercise to dietary restrictions, however, psychological treatments to target the gut-brain axis such as cognitive-behavior therapy (CBT) have also been shown to be an effective therapy, and aims to address the psychological and environmental stressors that contribute to the symptoms. Therefore the purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS. CBT has been shown to reduce the severity of intractable IBS symptoms by as much as 70%. The investigators hope to learn whether the Zemedy mobile application is effective in the reduction of IBS. This will be measured based on their IBS Symptom Severity Scores (SSS) at week 8 compared to baseline.

Official Title
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Zemedy - Evaluation of Zemedy, a Cognitive Behavioral Therapy-based Digital Therapeutic Application for the Treatment of Irritable Bowel Syndrome

Conditions
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IBS - Irritable Bowel Syndrome

Intervention / Treatment
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* Device: Use of Zemedy Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients >=18 years old. Meet Rome IV criteria for IBS for at least 6 months. No restrictions on type of IBS. English proficiency (in order to understand use of the application. Patient must be on a stable regimen for IBS for at least 30 days. Patients must own a smartphone (iOS or Android) in order to participate in the CBT application. Exclusion Criteria: Laboratory or imaging evidence of an alternative explanation of patient's symptoms. Active gastrointestinal disease such as Crohn's disease, ulcerative colitis, history of complete colon resection, acute infection, or any disease that precludes participation in CBT application. Patient already undergoing cognitive behavioral therapy. Psychiatric hospitalization within 10 years. Current or past diagnosis of a major mental illness such as schizophrenia, bipolar disorder, personality disorder or substance abuse. Active (within the past 3 months) suicidal ideation. Prisoners or other detained individuals. Adults unable to consent. Pregnant people.

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: Parallel Assignment
Interventional Model Description: Randomized trial comparing Zemedy CBT app vs. Treatment as usual
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group (TAU only)<br>Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy. | |
| Experimental: Experimental (TAU plus CBT)<br>Subjects who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU). | Device: Use of Zemedy Application<br>* 8 weeks of CBT via the Zemedy Application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS-SSS at 8 Weeks | Change in IBS symptoms based on the change in IBS symptom severity score (IBS-SSS) score at week 8 compared to baseline. Score range: 0-500 | Baseline and at Week 8. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS-SSS at 24 Weeks | Change in IBS symptoms based on the change in IBS symptom severity score (IBS-SSS) score at week 24 compared to baseline. Score range: 0-500 | Baseline and at Week 24. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Cognitive Behavioral Therapy, Self Help