Status:
RECRUITING
A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
Lead Sponsor:
Soroka University Medical Center
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Ben-Gurion University of the Negev
Conditions:
Crohn Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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, ...
Detailed Description
200 patients will be randomly divided into two groups - 100 patients will learn and practice COBMINDEX by a human therapist-social worker and 100 patients will learn and practice COBMINDEX by a digita...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06221254
Start Date
August 1 2023
End Date
August 1 2026
Last Update
January 24 2024
Active Locations (4)
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1
Soroka University Medical Center
Beersheba, Israel, 8410101
2
Rambam Health Care Campus i
Haifa, Israel, 3109601
3
Belinson Medical Center
Petah Tikva, Israel, 4941492
4
Sheba Medical Center
Ramat Gan, Israel, 5266202