Small Soteria-inspired unit vs. standard closed ward for acute psychosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares two inpatient care approaches for adults with moderate-to-severe acute psychosis admitted to a closed unit. Eligible participants are randomly assigned to a small unit that uses Soteria elements or to the standard closed ward, with allocation concealed at baseline when possible. Real-world constraints may affect randomization, including bed availability and consent timing. The study includes follow-up at one year, with compensation for in-person follow-up visits to support retention. Primary emphasis is on stabilizing acute symptoms and evaluating longer-term outcomes in a real clinical setting in Jerusalem.

Why it matters

Who can join: the full rules

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.

Where it's running

• Jerusalem Mental Health Center
  Jerusalem, Jerusalem, Israel Recruiting

Study contacts

• Principal investigator: Pesach Lichtenberg, MD — Jerusalem Mental Health Center
• Study coordinator: Avraham Friedlander, PhD
• Email: avremi13@gmail.com
• Phone: +972506801173

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.