[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542869":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":42,"armGroups":38,"interventions":38,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":64,"collaborators":38,"id":68,"slug":38,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":38,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":38,"studyType":79,"phases":38,"briefSummary":80,"conditions":81,"keywords":38,"overallStatus":52,"whyStopped":38,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Shalvata Mental Health Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":38},[9,13,16,19,22,25,28],{"measure":10,"description":11,"timeFrame":12},"Oxytocin Secretion","Endogenous oxytocin level in saliva","12-16 weeks, depending on treatment duration",{"measure":14,"description":15,"timeFrame":12},"Inflammatory Response: IL-1β","inflammatory biomarker IL-1β assessed in saliva",{"measure":17,"description":18,"timeFrame":12},"Inflammatory Response: IL-6","inflammatory biomarker IL-6 assessed in saliva",{"measure":20,"description":21,"timeFrame":12},"Inflammatory Response: TNF-α","inflammatory biomarker TNF-α assessed in saliva",{"measure":23,"description":24,"timeFrame":12},"Posttraumatic stress disorder symptoms","PTSD checklist for DSM-5 (PCL-5): Self-report questionnaire consisting of 20 items ranging from 0-4. High scores indicate worst outcome.",{"measure":26,"description":27,"timeFrame":12},"Depression severity","Patient health questionnaire (PHQ-9): Self-report questionnaire consisting of 9 items ranging from 0-3. High scores indicate worst outcome.",{"measure":29,"description":30,"timeFrame":12},"General anxiety symptoms","Generalized anxiety disorder (GAD-7): Self-report questionnaire consisting of 7 items ranging from 0-3. High scores indicate worst outcome.",[32,35],{"measure":33,"description":34,"timeFrame":12},"Psychological resilience","Conor-Davidson resilience scale (CD-RISC-10): Self-report questionnaire consisting of 10 items ranging from 0-4. High scores indicate better outcome.",{"measure":36,"description":37,"timeFrame":12},"Working Alliance","Short Alliance Inventory (SAI): Self-report questionnaire consisting of 6 items ranging from 0-5. High scores indicate better outcome.",null,{"allocation":38,"interventionModel":38,"interventionModelDescription":38,"primaryPurpose":38,"observationalModel":40,"timePerspective":41,"maskingInfo":38},"CASE_ONLY","PROSPECTIVE","Patients demonstrating PTSD symptoms following a traumatic event, seeking psychotherapy treatment in Shalvata Mental Health Center's trauma clinic.",[44],{"name":45,"role":46,"phone":47,"phoneExt":38,"email":48},"Omer Sedoff, MA","CONTACT","97297478555","omerse@clalit.org.il",[50],{"facility":51,"status":52,"city":53,"state":38,"zip":38,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Shalvata Mental health Center","RECRUITING","Hod HaSharon","Israel","IL",{"type":57,"coordinates":58},"Point",[59,60],34.8932,32.15934,{"lat":60,"lon":59},[63],{"name":45,"role":46,"phone":38,"phoneExt":38,"email":48},{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Yuval Bloch","Professor","100542869",false,"NCT06348472","The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness","Inclusion Criteria:\n\n* Minimum score of 33 on the PTSD symptoms questionnaire (PCL-5).\n* Anticipated 12-24 psychotherapy sessions.\n\nExclusion Criteria:\n\n* Psychotic episode.\n* Female patients: pregnancy or breastfeeding (according to self-report).","ALL","18 Years","80 Years",{"count":77,"type":78},100,"ESTIMATED","OBSERVATIONAL","Despite a range of treatments for posttraumatic stress disorder (PTSD), only a small proportion of patients reach full symptomatic remission. Recent developments in the field of neuroscience have been providing compelling evidence to suggest that neurobiological determinants might influence not only the emergence of PTSD, but also its resistance to treatment. Immune-inflammation regulatory processes were found to be active during recovery from PTSD, potentially through interactive relationship with the oxytocin secretion system. This innovative longitudinal study aims to examine the role of inflammatory biomarkers and their interactive effect with the oxytocin (OT) system on the development of PTSD and on treatment response among patients with PTSD symptoms undergoing psychotherapy treatment. Patients (N = 100) suffering from trauma-related distress will be recruited from the trauma clinic in Shalvata Mental Health Center. Participants will be followed for 12 weeks of once-a-week psychotherapy sessions. They will be measured for endogenous OT level and cytokines levels in saliva before and after sessions 1, 6, and 12, and will complete psychotherapy outcome self-report questionnaires following each of these sessions.",[82],"Posttraumatic Stress Disorder","2024-06-27",{"date":85,"type":86},"2024-06-28","ACTUAL",{"date":88,"type":86},"2024-03-14",{"date":90,"type":78},"2028-03-01",{"name":5,"class":6},1]