[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shalvata Mental Health Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":114},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,69,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100627954","mechanisms-and-outcomes-of-children-and-adolescent-psychotherapy-100627954",false,"NCT07455344","Mechanisms and Outcomes of Children and Adolescent Psychotherapy","Study 1:\n\nInclusion criteria will be children and adolescents who participated in outpatient psychotherapy in CHS databases.\n\nExclusion Criteria: Participants will be excluded in case of mental or physical hospitalization during psychotherapy.\n\nStudy 2:\n\nInclusion criteria for patients and caregivers include participation in psychotherapy in the Crisis Intervention Unit in Shalvata MHC. Inclusion criteria for therapists will be as follows (1) a professional license to practice psychotherapy (2) conducting psychotherapy in the child and adolescent clinic in Shalvata MHC. Patients and caregivers will be excluded in case of not being able to or willing to sign informed consent, or if there is an immediate risk, as evaluated by the treating physician.","ALL","6 Years",{"count":18,"type":19},30000,"ESTIMATED","OBSERVATIONAL","Since October 7th 2023, Israel's population has been forced to engage in a multi-regional war which affected most of the citizens of Israel. One of the most sensitive populations to be affected by the horrifying events are children and adolescents. In a meta-analysis summarizing the results of 20 studies encompassing a total of 26,302 children and adolescents, the authors reported a significant association between the degree of exposure to traumatic events and psychological distress (Slone et al., 2017). Furthermore, a recent study conducted in Ukraine during Russia's invasion indicated an increase in internalizing symptoms among children and adolescents, as reported by parents (McElroy et al., 2024). Nevertheless, to date, no study has evaluated the extent of distress, and overall mental and physical consequences among children and their parents, in the context of the October 7th events.\n\nOne of the main routes to provide care to children and adolescents inflicted by the consequences of war is through psychotherapy. Although psychotherapy is considered an effective treatment for children and adolescents, studies indicate that dropout rates among this population is as high as 45% (De Haan et al., 2013). Several predictors were previously offered to be associated with children and adolescents' dropout and psychotherapy outcomes. These predictors can be broadly categorized into two conceptual dimensions. The first is pre-treatment variables that are associated with both children and their parents, such as demographics (i.e., ethnicity, gender, age), diagnosis (including classification and co-morbidity), symptom severity, family characteristics, and parental problems and difficulties (De Soet et al., 2023; Skar et al., 2022). The second dimension is related to within-therapy factors, such as patients' expectations and the quality of mutual work with the therapist (O'Keeffe et al., 2018). Nonetheless, to date, no systematic study has assessed pre-treatment and within-treatment predictors of dropout and outcome in general or in the context of political conflict.\n\nResearch Objectives\n\nThis study aims to address current gaps in the literature by assessing the effects of October 7th events on parents, children, and adolescents. Furthermore, the study aims to assess the effects of psychotherapy provided in the settings of crisis intervention and treatment as usual in outpatient clinics to children following the war. Research objectives will be addressed using two methodological approaches: a retrospective big-data strategy exploration, and a prospective assessment of ongoing psychotherapies. Based on the reviewed literature, the following research hypotheses will be investigated:\n\n1. Parental psychopathology will mediate the association between traumatic exposure during war and their child's mental and physical health.\n2. Dropout rates from psychotherapy in Israel will be found as similar to those reported in a previous meta-analysis (\\~45%) (De Haan et al., 2013).\n3. Within-treatment variables will have a stronger association with dropout risk and outcome, compared to pre-treatment variables.",[23],"Mental Health",[25,26,27,28],"Child and Adolescent Psychotherapy","Dropout","Mechanisms and Outcomes","parental mental health","RECRUITING","2026-03-02",{"date":32,"type":33},"2026-03-06","ACTUAL",{"date":35,"type":33},"2025-01-05",{"date":37,"type":19},"2028-01-30",{"name":39,"class":40},"Shalvata Mental Health Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":20,"phases":4,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":41},"100585897","psychotherapy-expectations-and-distress-among-mental-health-patients-and-their-therapists-100585897","NCT06908343","Psychotherapy Expectations and Distress Among Mental Health Patients and Their Therapists.","The Associations Between Psychotherapy Expectations and Distress Among Adults Hospitalized in Psychiatric Departments or Treated in the Ambulatory\u002FCommunity Clinics and Their Therapists.","Inclusion Criteria:\n\n* Hebrew mother tongue speakers\n* Being treated at Shalvata MHC.\n\nExclusion Criteria:\n\n* Inability to read or comprehend Hebrew due to any reason.\n* Agitative patients\n* Acute suicidal patients\n* Patients in unstable psychotic state",{"count":50,"type":19},100,"2 Months","Patients will be recruited from the units of Shalvata MHC: closed and open hospitalization unit, and ambulatory units of Shalvata MHC community clinic. Their therapists will be recruited as well. There will be 4 timepoints measurement: baseline, second week, fourth week and after eight weeks (or discharge). Patients will be addressed through the therapeutic staff and the research team will contact them after a conceptually agreement to participate. A member of the research staff will schedule a meeting explaining the research thoroughly and ask the patient\u002Ftherapist to sign an informed consent. After signing an informed consent, patients will complete several questionnaires at several time points, whereas their therapists will complete measures as well. All scales will be filled using the Qualtrics platform. In hospitalization unit questionnaires will be filled with the aid of the research coordinator, and in the facilities of Shalvata MHC, in face-to-face interaction. During the face-to-face interaction, in case the patient will report suicidal thoughts or plan to a member of the research staff, the therapeutic staff will be notified immediately. patients at community clinics will fill the first measurement in face-to-face interaction and the rest of the questionnaires independently recieveg a link to their mobile phone.",[54,55],"Expectancy","Distress, Psychological",[57,58,59,60],"process expectations","distress","hospitalized patients","psychotherapy","2025-04-29",{"date":63,"type":33},"2025-05-02",{"date":65,"type":33},"2025-02-20",{"date":67,"type":19},"2025-12-31",{"name":39,"class":40},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":15,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":41},"100542869","the-predictive-role-of-immune-inflammatory-biomarkers-and-their-interaction-with-the-oxytocin-system-in-trauma-related-psychotherapy-responsiveness-100542869","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).","18 Years","80 Years",{"count":50,"type":19},"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.",[80],"Posttraumatic Stress Disorder","2024-06-27",{"date":83,"type":33},"2024-06-28",{"date":85,"type":33},"2024-03-14",{"date":87,"type":19},"2028-03-01",{"name":39,"class":40},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":15,"minAge":75,"maxAge":76,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":41},"100472454","phase-2-the-effects-of-oxytocin-administration-to-patients-and-therapists-on-physiological-synchronization-100472454","NCT05432089","The Effects of Oxytocin Administration to Patients and Therapists on Physiological Synchronization","The Effects of Oxytocin Administration to Patients and Therapists on Physiological Synchronization: a Randomized Controlled Pilot Study","Patients Inclusion Criteria:\n\n* age above 18.\n* any type of psychiatric illness.\n* hospitalization in one of the inpatients wards.\n\nPatients Exclusion Criteria:\n\n* current severe psychotic episode\n* pregnancy according to self-report.\n\nTherapist Inclusion Criteria:\n\n* psychologists, psychiatrists, and social workers, in different stages of seniority and training.\n\nTherapist Exclusion Criteria:\n\n* pregnancy according to self-report.",{"count":97,"type":19},120,"INTERVENTIONAL",[100],"PHASE2","Introduction: Oxytocin (OT) is a nine-amino acid neuropeptide, known to have a fundamental role in social communication. In a recent randomized, double-blind, placebo-controlled study carried out in Shalvata Mental Health Center, OT was administrated to patients suffering from severe mental health illness. The results indicated that OT has a clear beneficial effect on therapeutic outcomes. However, to our knowledge, the effect of OT administration to both patients and therapists on the therapeutic process was never tested. Substance administration to caregivers is therefore possible, and could, in some cases, provide further knowledge about the caregiving dynamics. Since we know the therapist's characteristics effect the therapeutic alliance and that OT is associated with the therapeutic alliance, patient-therapist bond, and therapy outcome, we are led to ask if OT administration to patients and therapists could allow for a deeper understanding of OT's effects on the therapeutic process.\n\nAnother variable found to be associated with the therapeutic process is Physiological Synchronization. Physiological Synchronization (PS) is a primarily interpersonal phenomenon which includes coordination of physiological signals between two or more interacting individuals. Despite the rising number of studies examining PS, its physiological and psychological mechanisms are yet to be fully understood. Based on literature indicating associations between OT and PS, and associations each of them has with the therapeutic process and its facilitators, in this study we wish to examine the influence of OT on PS through intranasal OT administration to patients alone and to patients and therapists together.\n\nResearch Hypotheses:\n\n1. Patients receiving OT will demonstrate higher levels of PS during the measured session compared to patients receiving placebo.\n2. Patients receiving OT will report higher levels of perceived therapist empathy as compared to patients receiving placebo.\n3. These associations will be stronger when both patient and therapist receive OT in comparison to patient alone.\n4. Changed in PS and empathy will be associated with OT even after controlling for patient rated alliance and session impact.\n5. These findings will sustain after controlling for severity of symptoms and attachment patterns.\n\nMethod:\n\nParticipants. Sixty patients and their therapists will be recruited for the pilot study. Patients will be recruited from the inpatient adult psychiatric wards at Shalvata Mental Health Center. Therapists in this study will be comprised of psychologists, psychiatrists, and social workers, in different stages of seniority and training.\n\nInstruments. Attachment patterns, symptom severity, side effects and therapeutic process measurements - working alliance, perceived empathy and session impact - will be assessed using self-report questionnaires. PS will be measured by recordings of the electrodermal activity (EDA) measured by skin conductance signals, using a galvanic skin response (GSR) device. Oxytocin Administration will be performed intranasally using a spray containing 24U.\n\nProcedure. Sixty patients meeting inclusion criteria and their therapists will be recruited for the pilot study. Dyads will be randomized and double-blindly allocated to receive intra-nasal oxytocin or placebo. Dyads will be followed for two consecutive sessions, approximately at their fourth and fifth sessions. After signing informed consent forms, patients and therapists will complete therapeutic process measurements, and patients will be assessed for the severity of their symptoms and attachment patterns. Prior to the first session, patients will be administrated with either IN-OT or PLC and will wait for 30 minutes before the beginning of the session. Skin conductance synchrony will be measured during the session. At the end of the session, therapeutic process measurements will be assessed in both patients and therapists, and patients will complete a side-effect questionnaire. Prior to the second session, both patients and therapists will receive either IN-OT or PLC (each dyad will receive the same substance) and will wait for 30 minutes before the beginning of the session. Skin conductance synchrony will then be measured during the session. At the end of the session, therapeutic process measurements will be assessed in both patients and therapists alongside with a side-effect questionnaire.\n\nThe uniqueness of the proposed study is rooted in the view of the psychotherapy dyad as undetached, by focusing on the dyad and not on the patient alone. Focusing on patient-therapist synchronization lies on the understanding of the patient-therapist bond as co-dependent and co-affected. Such research could increase our understanding of PS between patient and therapist and its meaning in psychotherapy research and practice.",[103],"Severe Mental Illness",[105,106,107],"Oxytocin","Physiological Synchronization","Psychotherapy",{"date":83,"type":33},{"date":110,"type":33},"2023-03-30",{"date":112,"type":19},"2026-07-01",{"name":39,"class":40},""]