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A Closed Unit Incorporating Soteria Elements Versus a Conventional Closed Psychiatric Ward

RecruitingNAAges 18 Years - anyMaleJerusalem Mental Health Center
NCT07836348 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. After 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. Because the study is conducted under real-world emergency psychiatric conditions, random allocation may not always be feasible because of clinical urgency, bed

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male participants aged 18 years or older. * Acute psychiatric condition requiring admission to a closed psychiatric inpatient setting. * 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. * Admission directly from the psychiatric emergency department. * Stay of at least 5 days in the assigned study inpatient setting. * Provision of informed consent to participate in the study. * Voluntary or involuntary legal admission status. Exclusion Criteria: * Previous psychiatric hospitalization ending less than one month before the current admission. * Hospitalization in the assigned study inpatient setting exceeding 180 days. * Substance use as the primary clinical problem requiring hospitalization. * Active organic medical condition requiring ongoing intensive medical monitoring. * Intellectual developmental disability. * Complex organic brain disorder, including dementia.
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What it tests

  • Inpatient Care in a Closed Unit Incorporating Soteria Elements
  • Conventional Closed Psychiatric Inpatient Care
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Where

1 site
Jerusalem Mental Health Center
Jerusalem, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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