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RECRUITINGINTERVENTIONAL

A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease

Israeli IBD Research Nucleus (IIRN) Consortium: COBMINDEX Goes Forward- A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - Willingness to participate and signed willing to sign a consent form - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

COBMINDEX digital application

COBMINDEX is a Cognitive, behavioral and mindfulness-based stress reduction with daily self-exercise. The intervention comprises of 7 sessions in which stress reduction techniques are learned. In this arm the Patient learns techniques and practices using digital application.

BEHAVIORAL

Human therapist (Control)

COBMINDEX is a Cognitive, behavioral and mindfulness-based stress reduction with daily self-exercise. The intervention comprises of 7 sessions in which stress reduction techniques are learned. In this arm the Patient learns techniques from a human therapist (the comperator for learning from the application) and practices using digital application.

Locations (4)

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