Israeli IBD Research Nucleus (IIRN) Consortium: COBMINDEX Goes Forward- A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Israel
Soroka University Medical Center
RECRUITING
Beersheba
Rambam Health Care Campus i
NOT_YET_RECRUITING
Haifa
Belinson Medical Center
NOT_YET_RECRUITING
Petah Tikva
Sheba Medical Center
NOT_YET_RECRUITING
Ramat Gan
Contact Information
Primary
Doron Schwartz, MD
DoronSh@clalit.org.il
+972-52-3919044
Backup
Shmuel Odes, MD
odes@bgu.ac.il
+972-52-2700752
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 200
Treatments
Experimental: Intervention- COBMINDEX application
The intervention in this arm is to learn during the first 3 months, cognitive, behavioral and mindfulness based stress reduction with daily exercise using a research dedicated application. Than, additional 9 months of practicing daily only with the application.
Active_comparator: Control- COBMINDEX with Human therapist
The intervention in this arm is to learn during the first 3 months, cognitive, behavioral and mindfulness based stress reduction with daily exercise with human therapist, and than practicing daily only with the application.
Related Therapeutic Areas
Sponsors
Leads: Soroka University Medical Center
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust, Ben-Gurion University of the Negev