An interventional study of COBMINDEX digital application and Human therapist (Control) in Crohn Disease, sponsored by Soroka University Medical Center. Recruiting at 4 sites in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Soroka University Medical Center · Not applicable, Interventional, and Treatment
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Among 201 studies in Crohn Disease with a site in Israel — 36 open to participants now, 54 under way, 27 of them phase 3. Crohn Disease · Israel.
Among the 201 studies in Crohn Disease with a site in Israel, this one is the 72nd largest by planned enrollment of the 168 interventional ones that give a count, is one of 12 that started in 2023, is one of 32 with no phase, reaches primary completion later than 20 of the 53 other live ones, and was the 173rd registered.
1,993 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
Browse Crohn Disease studies →36 of the 201 studies in Crohn Disease with a site in Israel are open now. Recruiting first, the newest first:
AbbVie · Sites in Israel, United States, Canada and 2 more countries
Ages 18–75
Janssen Research & Development, LLC · Sites in Israel, United States, Argentina and 27 more countries
Ages 18+
Eli Lilly and Company · Sites in Israel, United States, Belgium and 7 more countries
Ages 18–80
Eli Lilly and Company · Sites in Israel, United States, Belgium and 7 more countries
Ages 18–80
Sanofi · Sites in Israel, United States, Australia and 24 more countries
Ages 16–80
A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →
Of the 353 Crohn Disease studies recruiting now, 154 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 95 take children under 18; 56 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
201 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 49 · Phase 3 79 · Phase 4 10
First in 2002; this study’s year is marked. 12 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 67 across 1,261 interventional studies indexed under Crohn Disease.
Median enrollment 150 across the 168 interventional studies, 86 across the 32 observational. Of the 121 that completed or were terminated, 64 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
129 of 201 have an industry lead sponsor. The 10 most frequent:
Soroka University Medical Center is the lead sponsor of 160 studies on the registry; 2 are open to participants now.
Soroka University Medical Center has 4 studies filed under Crohn Disease — fewer than ten, so there is no comparison to draw.
16 of the studies in Crohn Disease with a site in Israel that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06063967Phase 3AbbVieA Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. | 2027-03 |
| NCT05347095Phase 3Janssen-Cilag Ltd.A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease | 2027-03-25 |
| NCT06408935Phase 3Janssen-Cilag Ltd.Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients | 2027-06-08 |
| NCT06227910Phase 3TakedaA Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease | 2027-06-08 |
| NCT03345823Phase 3AbbVieA Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433 | 2027-09 |
Add all 16 to your calendar (.ics) → With an account.
Among the 201 studies in Crohn Disease with a site in Israel, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: 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 with human therapist, and than practicing daily only with the application.
Behavioral: Human therapist (Control)
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.
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.
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.
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
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2023 (actual). Primary completion is estimated for May 2027, 45 months after the start.
Of 288 non-industry interventional studies with no phase under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 67. This study's planned 45 months is close to that.
Counting every sponsor, half of 300 studies reached it within 45 months; a quarter within 21 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
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