[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"crisis-response-plan\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:crisis-response-plan":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100602205","phase-4-esketamine-versus-crisis-response-planning-versus-optimized-treatment-as-usual-for-suicide-prevention-a-pragmatic-controlled-trial-in-two-brazilian-cities-100602205",false,"NCT07120477","Esketamine Versus Crisis Response Planning Versus Optimized Treatment as Usual for Suicide Prevention: A Pragmatic Controlled Trial in Two Brazilian Cities","SAVE","Inclusion Criteria:\n\n1. Age 14 years or older\n2. Presentation to a public emergency service (ED\u002FUEU) within the study municipality\n3. Recent suicide attempt within the past 30 days (actual, interrupted, or aborted attempt)\n4. Current severe suicidal ideation, defined as endorsement of items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) screening version, indicating active suicidal ideation with specific plan and\u002For method, or active suicidal ideation with intent to act\n5. Residency in the catchment area of the study municipality (Indaiatuba, São Paulo, Brazil), enabling completion of follow-up assessments\n6. Ability to provide written informed consent (for participants aged 18 years or older) or written assent with written informed consent from a parent or legal guardian (for participants aged 14-17 years)\n7. No clinical decision for involuntary or voluntary hospitalization in a psychiatric inpatient unit following the index emergency department evaluation\n\nExclusion Criteria:\n\n1. Contraindications to esketamine, including: aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, or known hypersensitivity to esketamine or ketamine\n2. Current pregnancy or breastfeeding (confirmed by rapid pregnancy test in the emergency setting for female participants of childbearing potential)\n3. Medical instability requiring intensive care unit (ICU) admission without feasible study follow-up\n4. Primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder), current acute psychosis, or current acute manic episode precluding informed participation\n5. Severe substance use disorder compromising capacity for treatment adherence, as assessed by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)\n6. Inability to maintain contact for follow-up assessments, including participants whose residential address is located outside the study municipality","ALL","14 Years",{"count":19,"type":20},468,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","Suicide is one of the leading causes of early death worldwide. In Brazil, suicide rates have been rising steadily over the past two decades, and most suicides occur in low- and middle-income countries where access to specialized care is limited. There is an urgent need for fast-acting, practical interventions that can be delivered in public emergency settings. Two promising approaches have emerged: esketamine, a medication that can rapidly reduce suicidal thoughts within hours, and Crisis Response Planning (CRP), a brief session in which a trained clinician works with the person to create a personalized written plan for managing future suicidal crises.\n\nThe goal of this clinical trial is to learn if esketamine or Crisis Response Planning (CRP), each added to enhanced treatment as usual (eTAU), can prevent future suicide-related events compared to eTAU alone in adolescents and adults aged 14 years or older who recently attempted suicide or have severe suicidal thoughts. The main questions it aims to answer are:\n\nDoes a single esketamine infusion plus eTAU lower the risk of a new suicide-related event compared to eTAU alone over 12 months? Does a single session of Crisis Response Planning plus eTAU lower the risk of a new suicide-related event compared to eTAU alone over 12 months? Which approach leads to faster or more lasting improvements in suicidal thoughts, depression, anxiety, sleep, well-being, hopelessness, and quality of life? Are these interventions feasible, acceptable, and cost-effective within a public health system?\n\nResearchers will compare three groups to see which approach works best to prevent suicide attempts, suicide-related hospitalizations, and suicide deaths over one year.\n\nA total of 468 participants will be randomly assigned in equal numbers (156 per group) to one of three groups:\n\nEsketamine group: receive a single intravenous esketamine infusion (0.50 mg\u002Fkg given over 40 minutes) in a monitored medical setting with continuous heart rate, blood pressure, and oxygen monitoring, plus eTAU. A physician will be present throughout. Participants will be observed for up to 24 hours before discharge.\n\nCrisis Response Planning group: complete one 20-to-45-minute session with a trained clinician to build a personal crisis plan that includes warning signs, coping strategies, reasons for living, support contacts, and emergency resources. Participants will leave with a written and digital copy of their plan, plus eTAU.\n\nEnhanced treatment as usual (eTAU) group: receive standard emergency care, safety counseling about access to lethal means, connection to the local mental health network (including Psychosocial Care Centers and primary care), and a scheduled psychiatric follow-up appointment within 7 days.\n\nParticipants will:\n\nComplete health questionnaires about suicidal thoughts, depression, anxiety, sleep, well-being, hopelessness, and quality of life at 11 time points over one year (at enrollment, 24 hours, 7 days, 2 weeks, 4 weeks, 8 weeks, 16 weeks, 24 weeks, 32 weeks, 40 weeks, and 1 year) Provide a blood sample at the start of the study for exploratory analyses of biological markers that may be related to treatment response Use a smartphone app to report their mood, thoughts, and emotions four times a day for four weeks after enrollment Be monitored for safety and adverse events throughout the entire study period\n\nThe study takes place in the public emergency network of Indaiatuba, São Paulo, Brazil (population approximately 256,000), and is designed to reflect real-world clinical conditions. Participants who experience a new suicide-related event during the study will be offered an open-label rescue treatment combining esketamine and Crisis Response Planning, and will continue to be followed for the remainder of the year. The study also includes an evaluation of how well these interventions can be adopted and sustained within Brazil's public mental health system, including assessments of acceptability, feasibility, and cost-effectiveness.",[26,27,28],"Suicide Prevention","Ketamine","Crisis Response Plan",[26,27,28],"RECRUITING","2026-06-28",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2026-06-01",{"date":38,"type":20},"2029-12",{"name":40,"class":41},"University of Sao Paulo","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100595452","reducing-crises-and-suicide-within-the-idaho-army-national-guard-100595452","NCT07032636","Reducing Crises and Suicide Within the Idaho Army National Guard","Reducing Crises and Suicide Within the Idaho Army National Guard - Enhancement of the First Line Leader Program","Inclusion Criteria:\n\n* Enlistment or commission in the Idaho ARNG at the time of enrollment\n* Age 18 or greater\n* Ability to complete all study questionnaires and interview procedures\n* Has at least one year remaining on National Guard contract\n\nExclusion Criteria:\n\n\\- Less than one year remaining on their contract with the National Guard",true,"18 Years",{"count":53,"type":20},450,[55],"NA","Military suicide is an ongoing public health concern, particularly within the Army National Guard (ARNG), with longstanding effects on fellow soldiers, family, and friends. The straddling of military and civilian worlds for ARNG can worsen risk factors for suicide, including increased social isolation, disruption to family life, and employment difficulties. One promising framework that addresses both unit cohesion and social support is the First Line Leaders (FLL) program, recently designated by ARNG for nation-wide dissemination. The program is centered on enhancing the relationship between junior enlisted soldiers (JES) and their assigned non-commissioned officer (NCO). The Investigators propose to study an augmented FLL program that includes templated guides developed in collaboration with Idaho ARNG stakeholders. The guides, referred to as TAP (Total Health Action Plan), were adapted from two empirically based interventions, Crisis Response Planning and Problem-Solving Therapy, and consist of prompts for open communication and effective engagement and guidelines for responding to impending or current behavioral distress. Given their elevated suicide risk, the Idaho ARNG is a crucial setting to develop this upstream intervention.\n\nIn this study, the Investigators propose to compare the augmented FLL + TAP program to FLL only, and training as usual (n= 50 NCOs and 100 JES per group) with quarterly assessments for up to one year. The Investigators will examine a random selection of deidentified counseling templates to examine the type and frequency of counseling sessions involving acute crisis and behavioral health difficulties, and online ratings from a random selection of JES using validated instruments to assess upstream indicators of behavioral distress and suicide risk and resilience. The Investigators will also conduct qualitative interviews with a random selection of 20% of the NCOs (n = 30) and JES (n = 60) enrolled in the project to provide personalized perspectives of program experiences.\n\nThe Investigators propose three aims to guide this research. (1) Collaborate with Idaho ARNG stakeholders to integrate TAP into FLL programming via: a) development and refinement of TAP training materials, b) building templated counseling statements that align with FLL and TAP, and c) education of Idaho ARNG training cadre in the delivery of TAP. (2) Evaluate fidelity, feasibility, and acceptability of FLL and FLL + TAP through a mixed methods approach of qualitative interviews with FLLs and JESs and evaluation of data from templated counseling sessions. (3) Examine the impact of FLL+TAP versus FLL versus training as usual on unit morale, cohesion, and general functioning.",[28,58],"Crisis Intervention","2026-06-25",{"date":61,"type":34},"2026-06-26",{"date":63,"type":34},"2026-06-15",{"date":65,"type":20},"2028-05-01",{"name":67,"class":41},"University of Rochester",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":42},"100586256","dv-100-as-a-framework-for-the-hospital-incident-command-system-100586256","NCT06913010","DV 100 as a Framework for the Hospital Incident Command System","The Service Regulation DV 100 as an Organizational Structure for Establishing the Hospital Incident Command System","OrAKEL","Inclusion Criteria:\n\n* Participation in at least one hospital incident command system (ICS) training and, if applicable, in a ICS exercise.\n\nWritten informed consent from the employee for participation in the second part of the study (semi-structured interview)\n\nExclusion Criteria:\n\n* Decline of study participation",{"count":77,"type":20},20,"OBSERVATIONAL","There is limited scientific research on the organizational structure of the Hospital Incident Command System. The Hospital Alarm and Emergency Planning manual by the German Federal Office of Civil Protection and Disaster Assistance (BBK) recommends a continental staff system-based organization, as outlined in the Service Regulation DV 100, similar to military, fire, and police structures. This approach is frequently discussed at professional conferences, but evidence on its functionality in hospitals is lacking. This study aims to generate new insights into the use of a continental staff system-based Hospital Incident Command System and qualitatively analyze transition and communication processes within the command structure.",[81,28,82,83],"Disaster","Emergency","Communication",[85,86,87,88,89,90,91,92,93,94,95,96,97,98,99],"Hospital Incident Command System","Continental Staff System","Service Regulation DV 100","Disaster Management","Emergency Planning","Hospital Alarm and Emergency Planning","Organizational Structure","Crisis Management","Communication Processes","Transition Processes","Healthcare Emergency Response","Civil Protection","Disaster Assistance","Incident Command Structure","Emergency Management Systems","2025-07-10",{"date":102,"type":34},"2025-07-11",{"date":104,"type":34},"2025-04-29",{"date":106,"type":20},"2026-10-31",{"name":108,"class":41},"University Hospital Heidelberg"]