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| ID | Type | Description | Link |
|---|---|---|---|
| SCRC22051 | Other Identifier | Soroka Clinical Research Center | |
| MOH_2023-04-30_012589 | Registry Identifier | Ministry of Health MyTrial | |
| 2203-05901 | Other Grant/Funding Number | The Leona M. and Harry B. Helmsley Charitable Trust |
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| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
| Ben-Gurion University of the Negev | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention- COBMINDEX application | Experimental | 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. |
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| Control- COBMINDEX with Human therapist | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COBMINDEX digital application | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doron Schwartz, MD | Contact | +972-52-3919044 | DoronSh@clalit.org.il | |
| Shmuel Odes, MD | Contact | +972-52-2700752 | odes@bgu.ac.il |
| Name | Affiliation | Role |
|---|---|---|
| Ruthie Bekore, MPH | Soroka University Medical Center | Study Director |
| Ganit Goren, PhD | Ben-Gurion University of the Negev | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka University Medical Center | Recruiting | Beersheba | 8410101 | Israel |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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200 CD patients divided into two equal groups: Intervention and control.
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| Human therapist (Control) | Behavioral | 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. |
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| 12 months |
| Effects of intervention on microbiome | alpha + beta diversity | 12 months |
| Psychological improvment | Psychological self-report questionnaires WPAI- Work Productivity and Activity Impairment. four types of scores:
| 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. | 12 months |
| Psychological improvment | Psychological self-report questionnaires FACIT-CD, FACIT Fatigue Scale 13-item measure 0-4. range 0-52 higher is worse. | 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. | 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") | 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. | 12 months |
| Psychological improvment | Psychological self-report questionnaires FMI, Freiburg Mindfulness Inventory 14 items range 0-4 higher is better. | 12 months |
| Psychological improvment | Psychological self-report questionnaires SUDS- Subjective Units of Distress Scale. range 0-100 higher is worse. | 12 months |
| disease severity measurement | C Reactive Protein mg/dl 0- 100 normal range 0-0.5 higher means more inflammation. | 12 months |
| disease severity measurement | calprotectin (microg/g) 0-8000 normal range 0-50 higher means more inflammation. | 12 months |
| disease severity measurement | Harvey Bradshaw Index - Crohn's disease symptom score range 0-36. higher is worse. | 12 months |
| Rambam Health Care Campus i | Not yet recruiting | Haifa | 3109601 | Israel |
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| Belinson Medical Center | Not yet recruiting | Petah Tikva | 4941492 | Israel |
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| Sheba Medical Center | Not yet recruiting | Ramat Gan | 5266202 | Israel |
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| D007410 | Intestinal Diseases |