[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533087":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":48,"responsibleParty":109,"collaborators":113,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":119,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":26,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Soroka University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: COBMINDEX digital application",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Behavioral: Human therapist (Control)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","COBMINDEX 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 and practices using digital application.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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 from a human therapist (the comperator for learning from the application) and practices using digital application.",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Ruthie Bekore, MPH","STUDY_DIRECTOR",{"name":36,"affiliation":37,"role":34},"Ganit Goren, PhD","Ben-Gurion University of the Negev",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Doron Schwartz, MD","CONTACT","+972-52-3919044","DoronSh@clalit.org.il",{"name":45,"role":41,"phone":46,"phoneExt":26,"email":47},"Shmuel Odes, MD","+972-52-2700752","odes@bgu.ac.il",[49,66,81,95],{"facility":5,"status":50,"city":51,"state":26,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Beersheba","8410101","Israel","IL",{"type":56,"coordinates":57},"Point",[58,59],34.7913,31.25181,{"lat":59,"lon":58},[62,64],{"name":40,"role":41,"phone":63,"phoneExt":26,"email":43},"+972523919044",{"name":45,"role":41,"phone":65,"phoneExt":26,"email":47},"+97252700752",{"facility":67,"status":68,"city":69,"state":26,"zip":70,"country":53,"countryCode":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Rambam Health Care Campus i","NOT_YET_RECRUITING","Haifa","3109601",{"type":56,"coordinates":72},[73,74],34.99928,32.81303,{"lat":74,"lon":73},[77],{"name":78,"role":41,"phone":79,"phoneExt":26,"email":80},"Haggai Bar-Yoseph, MD","+972-4-7772850","h_bar-yoseph@rambam.health.gov.il",{"facility":82,"status":68,"city":83,"state":26,"zip":84,"country":53,"countryCode":54,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Belinson Medical Center","Petah Tikva","4941492",{"type":56,"coordinates":86},[87,88],34.88747,32.08707,{"lat":88,"lon":87},[91],{"name":92,"role":41,"phone":93,"phoneExt":26,"email":94},"Henat Yanai, MD","+972-3-9377040","henitya@clalit.org.il",{"facility":96,"status":68,"city":97,"state":26,"zip":98,"country":53,"countryCode":54,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Sheba Medical Center","Ramat Gan","5266202",{"type":56,"coordinates":100},[101,102],34.81065,32.08227,{"lat":102,"lon":101},[105],{"name":106,"role":41,"phone":107,"phoneExt":26,"email":108},"Adi Lahat -Zok, Prof.","+972-3-302197","zokadi@gmail.com",{"type":110,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Dr Doron Schwartz","Senior Physician, Department of Gastroenterology and Hepatology",[114,116],{"name":115,"class":6},"The Leona M. and Harry B. Helmsley Charitable Trust",{"name":37,"class":6},"100533087","a-smartphone-application-for-added-psychological-wellbeing-in-crohns-disease-100533087",false,"NCT06221254","A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease","Israeli IBD Research Nucleus (IIRN) Consortium: COBMINDEX Goes Forward- A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease","COBMINDEX","Inclusion Criteria:\n\n* Willingness to participate and signed informed consent\n* Hebrew-speaking\n* Age 18-75\n* Proven diagnosis of Crohn's disease, at least 3 months post-diagnosis\n* Stable medical treatment for the last 3 months\n* Any Harvey Bradshaw Index score\n* Ability to operate a smartphone and cellular application\n\nExclusion Criteria:\n\n* Diagnosis of ulcerative colitis or unclassified inflammatory bowel disease\n* Planned surgery for Crohn's disease\n* Surgery for Crohn's disease (excluding drainage of perianal abscess) in the last 3 months\n* Psychiatric disease (schizophrenia, major depression or bipolar disorder)\n* Alcohol or drug dependency (stable medical use of cannabinoids will be allowed)\n* Pregnancy or planned pregnancy during study period\n* Clinically significant comorbidity\n* Former participation in COBMINDEX trials","ALL","18 Years","75 Years",{"count":129,"type":130},200,"ESTIMATED","INTERVENTIONAL",[133],"NA","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.",[136],"Crohn Disease",[138,139,140,141,142,143],"Crohn's Disease","Health related quality of life","Cognitive behavioral therapy","Mindfulness","Immune regulation","Healthcare cost","2026-04-26",{"date":146,"type":147},"2026-04-30","ACTUAL",{"date":149,"type":147},"2023-08-01",{"date":151,"type":130},"2027-08-01",{"name":5,"class":6},4]