A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
Recruiting · NCT06221254 · Interventional (participants receive a specific treatment) · Lead sponsor: Soroka University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
COBMINDEX digital applicationHuman therapist (Control)
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
4 locations listed.
- Soroka University Medical Center - Beersheba, Israel
- Rambam Health Care Campus i - Haifa, Israel
- Belinson Medical Center - Petah Tikva, Israel
- Sheba Medical Center - Ramat Gan, Israel