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Recruiting NCT06221254

A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease

Trial Parameters

Condition Crohn Disease
Sponsor Soroka University Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-08-01
Completion 2025-12-31
Interventions
COBMINDEX digital applicationHuman therapist (Control)

Brief Summary

Psychological intervention by COBMINDEX application to reduce psychological stress among CD patients, fatigue and pain and improve the patients' well being, quality-of-life and disease-coping skills, as well as improvement of the patients' immunological profile and intestinal microbiome.

Eligibility Criteria

Inclusion Criteria: * Willingness to participate and signed informed consent * Hebrew-speaking * Age 18-75 * Proven diagnosis of Crohn's disease, at least 3 months post-diagnosis * Stable medical treatment for the last 3 months * Any Harvey Bradshaw Index score * Ability to operate a smartphone and cellular application Exclusion Criteria: * Diagnosis of ulcerative colitis or unclassified inflammatory bowel disease * Planned surgery for Crohn's disease * Surgery for Crohn's disease (excluding drainage of perianal abscess) in the last 3 months * Psychiatric disease (schizophrenia, major depression or bipolar disorder) * Alcohol or drug dependency (stable medical use of cannabinoids will be allowed) * Pregnancy or planned pregnancy during study period * Clinically significant comorbidity * Former participation in COBMINDEX trials

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