NCT Number: NCT06221254
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Soroka University Medical Center, Beersheba, Israel
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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
Time frame: 12 months
alpha + beta diversity
Time frame: 12 months
Psychological self-report questionnaires
WPAI- Work Productivity and Activity Impairment. four types of scores:
Time frame: 12 months
Psychological self-report questionnaires
SWLS -The 5-item scale 0-7 "satisfaction with life scale" range 0-35 higher is better.
Time frame: 12 months
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 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 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 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 self-report questionnaires
FMI, Freiburg Mindfulness Inventory 14 items range 0-4 higher is better.
Time frame: 12 months
Psychological self-report questionnaires
SUDS- Subjective Units of Distress Scale. range 0-100 higher is worse.
Time frame: 12 months
C Reactive Protein mg/dl 0- 100 normal range 0-0.5 higher means more inflammation.
Time frame: 12 months
calprotectin (microg/g) 0-8000 normal range 0-50 higher means more inflammation.
Time frame: 12 months
Harvey Bradshaw Index - Crohn's disease symptom score range 0-36. higher is worse.
Contact information is provided by the study sponsor or research team.
Doron Schwartz, MD
CONTACT
Shmuel Odes, MD
CONTACT
Soroka University Medical Center
Other
Israeli IBD Research Nucleus (IIRN) Consortium: COBMINDEX Goes Forward- A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
Acronym: COBMINDEX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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