[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jerusalem Mental Health Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100657232","a-closed-unit-incorporating-soteria-elements-versus-a-conventional-closed-psychiatric-ward-100657232",false,"NCT07836348","A Closed Unit Incorporating Soteria Elements Versus a Conventional Closed Psychiatric Ward","Psychiatric Hospitalization in a Closed Unit Incorporating Soteria Elements Versus a Conventional Closed Psychiatric Ward: A Randomized Controlled Trial","CSCW","Inclusion Criteria:\n\n* Male participants aged 18 years or older.\n* Acute psychiatric condition requiring admission to a closed psychiatric inpatient setting.\n* Moderate-to-severe psychotic symptoms, defined as a six-item Positive and Negative Syndrome Scale (PANSS-6) total score greater than 14 and at least one PANSS-6 item rated 5 or higher.\n* Admission directly from the psychiatric emergency department.\n* Stay of at least 5 days in the assigned study inpatient setting.\n* Provision of informed consent to participate in the study.\n* Voluntary or involuntary legal admission status.\n\nExclusion Criteria:\n\n* Previous psychiatric hospitalization ending less than one month before the current admission.\n* Hospitalization in the assigned study inpatient setting exceeding 180 days.\n* Substance use as the primary clinical problem requiring hospitalization.\n* Active organic medical condition requiring ongoing intensive medical monitoring.\n* Intellectual developmental disability.\n* Complex organic brain disorder, including dementia.","MALE","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","This prospective study compares two models of inpatient psychiatric care for adults experiencing an acute psychotic episode of moderate to severe intensity that requires admission to a closed psychiatric setting. Participants may have a history of previous psychiatric hospitalizations.\n\nAfter informed consent and completion of all baseline assessments, eligible participants are randomly assigned to either a small closed unit incorporating Soteria elements or a conventional closed psychiatric ward at the Jerusalem Mental Health Center. Treatment allocation remains concealed during the baseline assessment, so that participants and researchers completing the initial assessments do not know the participant's future treatment setting.\n\nBecause the study is conducted under real-world emergency psychiatric conditions, random allocation may not always be feasible because of clinical urgency, bed availability, administrative constraints, or difficulty obtaining consent and completing study procedures during an acute psychotic episode. When randomization cannot be implemented, eligible participants may still be enrolled and their method of allocation will be documented.\n\nThe closed unit incorporating Soteria elements provides care in a smaller setting of approximately 10 patients and emphasizes a calm and less institutional environment, supportive therapeutic relationships, shared decision-making whenever possible, personal autonomy, reduced reliance on coercive practices, and careful optimization of medication. The conventional closed ward provides standard acute inpatient psychiatric care in a larger ward setting.\n\nThe primary aims are to compare the relationship between antipsychotic medication dosage and improvement in psychotic symptoms, as well as therapeutic alliance and satisfaction with care, between the two treatment settings. Secondary outcomes include personal recovery, sense of dignity, internalized stigma, adverse events and coercive interventions during hospitalization, length of stay, and other clinical and post-discharge outcomes. Psychiatric readmission within one year after discharge is included as a primary outcome.\n\nBaseline assessments are completed before treatment allocation is disclosed. At discharge and follow-up, full blinding is not always feasible because participants may reveal their treatment setting; however, outcome assessments will be conducted with partial blinding whenever possible, and the success of blinding will be documented.\n\nThe primary statistical analysis will focus on participants who were randomly assigned. Additional analyses will compare randomly and non-randomly allocated participants and will include all eligible participants using statistical adjustment for relevant baseline differences and potential confounding. Sensitivity analyses restricted to the randomized sample will be conducted to assess the robustness of the findings.",[27],"Psychotic Disorders",[29,30,31,32,33,34],"Acute Psychosis","Soteria","Closed Psychiatric Ward","Locked Psychiatric Unit","Psychiatric Hospitalization","Recovery-Oriented Care","RECRUITING","2026-09-17",{"date":38,"type":39},"2026-09-23","ACTUAL",{"date":41,"type":39},"2025-09-25",{"date":43,"type":21},"2029-06-01",{"name":45,"class":46},"Jerusalem Mental Health Center","OTHER_GOV",""]