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A Study Comparing a Smartphone Application and Human Therapist for Psychological Wellbeing in Adults with Crohns Disease
Led by Soroka University Medical Center · Updated on 2026-04-30
200
Participants Needed
4
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the COBMINDEX smartphone application to reduce psychological stress, fatigue, and pain in adults with Crohns disease. The study aims to improve patients well-being, quality of life, coping skills, immunological profile, and intestinal microbiome. This is an interventional trial involving behavioral therapy techniques. Participants will be divided into two groups of 100 each. One group will learn and practice COBMINDEX techniques from a human therapist over three months, while the other group will use the digital COBMINDEX application guided by a digital therapist. Following this initial period, both groups will continue practicing daily with the application for an additional nine months. During the 12-month study, patients will be assessed daily for stress, pain, fatigue, and well-being. Frequent evaluations will include medical, psychological, and immunological status assessments. Researchers will also monitor adverse events and concomitant medications. The primary outcome is the effectiveness of the application compared to the human therapist over 12 months.
CONDITIONS
Brief Title
A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
Research Team
D
Doron Schwartz, MD
S
Shmuel Odes, MD
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