A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
- Conditions
- Crohn Disease
- Interventions
- Behavioral: COBMINDEX digital applicationBehavioral: Human therapist (Control)
- Registration Number
- NCT06221254
- Lead Sponsor
- Soroka University Medical Center
- 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.
- Detailed Description
200 patients will be randomly divided into two groups - 100 patients will learn and practice COBMINDEX by a human therapist-social worker and 100 patients will learn and practice COBMINDEX by a digital therapist using the COBMINDEX application.
In the first 3-months there will be an assessment of patient progress following randomization to human therapist or digital therapist using the application for learning and practicing. During this period, the group of the human social-worker will have a limited access to the application dedicated for daily exercises and assessment.
In the following 9-month period, all patients will practice using the application, each group by it's permissions.
There will be daily assessment of stress, pain, fatigue, well-being and frequent assessments of patients' medical, psychological, and immunological status.
Throughout the trial, adverse events and concomitant medications will be collected.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention- COBMINDEX application COBMINDEX digital application The intervention in this arm is to learn during the first 3 months, cognitive, behavioral and mindfulness based stress reduction with daily exercise using a research dedicated application. Than, additional 9 months of practicing daily only with the application. Control- COBMINDEX with Human therapist Human therapist (Control) The intervention in this arm is to learn during the first 3 months, cognitive, behavioral and mindfulness based stress reduction with daily exercise with human therapist, and than practicing daily only with the application.
- Primary Outcome Measures
Name Time Method Effectiveness of application as compared to human therapist. 12 months Develop a smartphone application that will teach the patient COBMINDEX and to determine whether the application will be as effective as the psychological intervention delivered by the therapists.
the primary end point is SIBDQ disease specific HRQOL. 10 questions each scale 1-7 with range 7-70. higher is better.
- Secondary Outcome Measures
Name Time Method disease severity measurement 12 months Harvey Bradshaw Index - Crohn's disease symptom score range 0-36. higher is worse.
Effects of intervention on microbiome 12 months alpha + beta diversity
Psychological improvment 12 months Psychological self-report questionnaires
SUDS- Subjective Units of Distress Scale. range 0-100 higher is worse.Cost-effectiveness 12 months To determine the cost-effectiveness of the intervention as provided by application versus therapists by prospective monitoring of direct and indirect healthcare costs. A cost-effectiveness analysis to assess the value for money of the application versus therapist interventions will be performed using primary data collected from patients in the study. These data include information of utilization of healthcare services reported by patients. The cost of each service will be based on the Israel Ministry of Health List Price for health services. We will calculate indirect costs of lost productivity based on patient responses to the WPAI questionnaire. For each patient we will calculate the quality-adjusted life-year (QALY) based on responses to the SF-12 questionnaires
Trial Locations
- Locations (4)
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Soroka University Medical Center
🇮🇱Be'er Sheva, Israel
Rambam Health Care Campus i
🇮🇱Haifa, Israel
Belinson Medical Center
🇮🇱Petah Tikva, Israel