Zemedy Application for Irritable Bowel Syndrome
Trial ID or NCT#
NCT04723056
Status
NOT RECRUITING
Purpose
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.
Official Title
Zemedy - Evaluation of Zemedy, a Cognitive Behavioral Therapy-based Digital Therapeutic Application for the Treatment of Irritable Bowel Syndrome
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Male and female patients >=18 years old. 2. Meet Rome IV criteria for IBS for at least 6 months. No restrictions on type of IBS. 3. English proficiency (in order to understand use of the application. 4. Patient must be on a stable regimen for IBS for at least 30 days. 5. Patients must own a smartphone (iOS or Android) in order to participate in the CBT application.
Exclusion Criteria:
- 1. Laboratory or imaging evidence of an alternative explanation of patient's symptoms. 2. 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. 3. Patient already undergoing cognitive behavioral therapy. 4. Psychiatric hospitalization within 10 years. 5. Current or past diagnosis of a major mental illness such as schizophrenia, bipolar disorder, personality disorder or substance abuse. 6. Active (within the past 3 months) suicidal ideation. 7. Prisoners or other detained individuals. 8. Adults unable to consent. 9. Pregnant people.
Investigator(s)
Linda Nguyen
Gastroenterologist,
Motility specialist
Clinical Professor, Medicine - Gastroenterology & Hepatology
Contact us to find out if this trial is right for you.
Contact
Britany D Marsh, BA
650-725-9321
View on ClinicalTrials.gov
