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
Soroka University Medical Center
200 participants
Aug 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria8
- 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
Interventions
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.
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)
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NCT06221254