NCT06221254 A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
| NCT ID | NCT06221254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Soroka University Medical Center |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-08-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Ruthie Bekore, MPH
STUDY DIRECTOR
Soroka University Medical Center
Frequently Asked Questions
Who can join the NCT06221254 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06221254 currently recruiting?
Yes, NCT06221254 is actively recruiting participants. Contact the research team at DoronSh@clalit.org.il for enrollment information.
Where is the NCT06221254 trial being conducted?
This trial is being conducted at Beersheba, Israel, Haifa, Israel, Petah Tikva, Israel, Ramat Gan, Israel.
Who is sponsoring the NCT06221254 clinical trial?
NCT06221254 is sponsored by Soroka University Medical Center. The principal investigator is Ruthie Bekore, MPH at Soroka University Medical Center. The trial plans to enroll 200 participants.