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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
Soroka University Medical Center
Beersheba, Israel
RECRUITINGRambam Health Care Campus i
Haifa, Israel
NOT_YET_RECRUITINGBelinson Medical Center
Petah Tikva, Israel
NOT_YET_RECRUITINGEffectiveness of application as compared to human therapist.
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.
Time frame: 12 months
Cost-effectiveness
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
Time frame: 12 months
Effects of intervention on microbiome
alpha + beta diversity
Time frame: 12 months
Psychological improvment
Psychological self-report questionnaires WPAI- Work Productivity and Activity Impairment. four types of scores: 1. Absenteeism 2. Presenteesism 3. Work productivty loss 4. Activity Impairment all presented in presentage 0-100. higher is worse.
Time frame: 12 months
Psychological improvment
Psychological self-report questionnaires SWLS -The 5-item scale 0-7 "satisfaction with life scale" range 0-35 higher is better.
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Sheba Medical Center
Ramat Gan, Israel
Time frame: 12 months
Psychological improvment
Psychological self-report questionnaires FACIT-CD, FACIT Fatigue Scale 13-item measure 0-4. range 0-52 higher is worse.
Time frame: 12 months
Psychological improvment
Psychological self-report questionnaires Brief COPE- The Brief-COPE is a 28 item self-report questionnaire range 0-4 higher is worse.
Time frame: 12 months
Psychological improvment
Psychological self-report questionnaires . BSI- The Brief Symptom Inventory a 53-item self-report inventory in which participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely")
Time frame: 12 months
Psychological improvment
Psychological self-report questionnaires PSS-4, Perceived Stress Scale 4. 4-item 0-4 score. range 0-16 higher is worse.
Time frame: 12 months
Psychological improvment
Psychological self-report questionnaires FMI, Freiburg Mindfulness Inventory 14 items range 0-4 higher is better.
Time frame: 12 months
Psychological improvment
Psychological self-report questionnaires SUDS- Subjective Units of Distress Scale. range 0-100 higher is worse.
Time frame: 12 months
disease severity measurement
C Reactive Protein mg/dl 0- 100 normal range 0-0.5 higher means more inflammation.
Time frame: 12 months
disease severity measurement
calprotectin (microg/g) 0-8000 normal range 0-50 higher means more inflammation.
Time frame: 12 months
disease severity measurement
Harvey Bradshaw Index - Crohn's disease symptom score range 0-36. higher is worse.
Time frame: 12 months