Actively Recruiting
Israeli IBD Research Nucleus (IIRN) Consortium: COBMINDEX Goes Forward- A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
Led by Soroka University Medical Center · Updated on 2026-04-30
200
Participants Needed
4
Research Sites
8 weeks
Total Duration
On this page
Sponsors
S
Soroka University Medical Center
Lead Sponsor
T
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborating Sponsor
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 Crohn's 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants learn cognitive, behavioral, and mindfulness-based stress reduction techniques either from a human therapist or via a digital application, practicing daily exercises during this period.
Regular daily practice with assessments
Duration - 9 months
Participants continue daily practice using the COBMINDEX application with permissions according to their group assignment, with ongoing assessment of stress, pain, fatigue, well-being, and medical, psychological, and immunological status.
Daily assessments throughout this period
Trial Site Locations
Total: 4 locations
1
Soroka University Medical Center
Beersheba, Israel, 8410101
Actively Recruiting
2
Rambam Health Care Campus i
Haifa, Israel, 3109601
Not Yet Recruiting
3
Belinson Medical Center
Petah Tikva, Israel, 4941492
Not Yet Recruiting
4
Sheba Medical Center
Ramat Gan, Israel, 5266202
Not Yet Recruiting
Research Team
D
Doron Schwartz, MD
S
Shmuel Odes, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here