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

NCT07836348 | Recruiting

• 1 other identifier: JMHC-9-22
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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 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. The 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. The 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. Baseline 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. The 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.

Conditions

Psychotic Disorders

Keywords

Acute Psychosis; Soteria; Closed Psychiatric Ward; Locked Psychiatric Unit; Psychiatric Hospitalization; Recovery-Oriented Care

Outcome Measures

Primary Outcomes (7)

• Change in Psychotic Symptom Severity From Admission to Discharge

  Psychotic symptom severity will be assessed using the six-item Positive and Negative Syndrome Scale (PANSS-6) at admission and discharge. The PANSS-6 includes three positive-symptom items and three negative-symptom items. Each item is rated from 1 to 7, and total scores range from 6 to 42, with higher scores indicating greater psychotic symptom severity. Change in PANSS-6 total score from admission to discharge will be compared between the two treatment settings.

  Baseline and at discharge, up to 180 days after admission

• Therapeutic Alliance With the Treatment Team Assessed by the Session Alliance Inventory

  Therapeutic alliance will be assessed at discharge using the patient version of the six-item Session Alliance Inventory (SAI), adapted so that all items refer to the treatment team as a whole rather than to an individual therapist. Each item is rated on a 1-to-7 scale, with higher scores indicating a stronger perceived therapeutic alliance. The total score is calculated by summing the six items and ranges from 6 to 42.

  At discharge, up to 180 days after admission

• Satisfaction With Care Assessed by the Client Satisfaction Questionnaire-8

  Satisfaction with inpatient psychiatric care will be assessed at discharge using the eight-item Client Satisfaction Questionnaire (CSQ-8). Each item is rated on a 1-to-4 scale. The total score is calculated by summing the eight items and ranges from 8 to 32, with higher scores indicating greater satisfaction with care.

  At discharge, up to 180 days after admission

• Psychiatric Readmission Within One Year After Discharge

  Psychiatric readmission during the first year after discharge will be assessed as a binary outcome indicating whether the participant was readmitted to a psychiatric hospital within one year of discharge. The proportion of participants with at least one psychiatric readmission will be compared between the two treatment settings.

  1 year after discharge

• Antipsychotic Medication Dose During Hospitalization

  Antipsychotic medication dosage will be assessed at baseline, on Day 14 for participants who remain hospitalized at that time, and at discharge. Antipsychotic doses will be converted to olanzapine-equivalent doses. Medication dose trajectories over time will be compared between the two treatment settings.

  Baseline, Day 14 if still hospitalized, and at discharge, up to 180 days after admission

• Anxiolytic Medication Dose During Hospitalization

  Anxiolytic medication dosage will be assessed at baseline, on Day 14 for participants who remain hospitalized at that time, and at discharge. Anxiolytic doses will be converted to diazepam-equivalent doses. Medication dose trajectories over time will be compared between the two treatment settings.

  Baseline, Day 14 if still hospitalized, and at discharge, up to 180 days after admission

• Time to First Psychiatric Readmission Within One Year After Discharge

  For participants who experience a psychiatric readmission within one year after discharge, time from discharge to the first psychiatric readmission will be measured in days. Time to first psychiatric readmission will be compared between the two treatment settings.

  From discharge through 1 year after discharge

Secondary Outcomes (9)

• Legal Admission Status and Changes During Hospitalization

  Baseline through discharge, up to 180 days after admission

• Adverse Events and Interventions During Hospitalization

  From admission through discharge, up to 180 days

• Change in Sense of Dignity From Admission Through One-Year Follow-Up

  Baseline, at discharge up to 180 days after admission, and 1 year after discharge

• Change in Self-Stigma From Admission Through One-Year Follow-Up

  Baseline, at discharge up to 180 days after admission, and 1 year after discharge

• Discharge Reason and Post-Discharge Disposition

  At discharge, up to 180 days after admission

Other Outcomes (5)

• Retrospective Evaluation of Therapeutic Alliance at One-Year Follow-Up

  Approximately one year after discharge

• Retrospective Satisfaction With Inpatient Care at One-Year Follow-Up

  Approximately one year after discharge

• Length of Stay in the Study Inpatient Setting

  From admission through discharge, up to 180 days

Study Arms (2)

Closed Unit Incorporating Soteria Elements

EXPERIMENTAL

Participants receive inpatient psychiatric treatment in a small closed unit of approximately 10 patients that incorporates Soteria principles. The treatment environment emphasizes a calm and less institutional atmosphere, supportive and sustained therapeutic relationships, shared decision-making whenever possible, personal autonomy, relational safety, reduced reliance on coercive practices, and careful optimization of psychiatric medication.

Other: Inpatient Care in a Closed Unit Incorporating Soteria Elements

Conventional Closed Psychiatric Ward

ACTIVE COMPARATOR

Participants receive standard acute inpatient psychiatric treatment in a conventional closed psychiatric ward. Care includes routine psychiatric assessment, medication management, nursing care, multidisciplinary treatment, structured ward procedures, and other standard interventions provided according to clinical need.

Other: Conventional Closed Psychiatric Inpatient Care

Interventions

Conventional Closed Psychiatric Inpatient Care OTHER

Standard psychiatric inpatient treatment provided in a conventional closed ward, including psychiatric and nursing care, medication management, multidisciplinary treatment, structured supervision, and routine ward procedures.

Also known as: Standard Closed Ward, Conventional Closed Ward

Conventional Closed Psychiatric Ward

Inpatient Care in a Closed Unit Incorporating Soteria Elements OTHER

A psychiatric inpatient treatment model delivered in a small closed unit incorporating Soteria principles, including a less institutional environment, intensive supportive relationships, shared decision-making, promotion of autonomy, relational safety, reduced reliance on coercion, and medication optimization.

Also known as: Soteria-Informed Closed Unit, Closed Soteria

Closed Unit Incorporating Soteria Elements

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jerusalem Mental Health Center: lead
• Moshe Hess Amuta: collaborator

Study Sites (1)

Jerusalem Mental Health Center

Jerusalem, Jerusalem, 9387197, Israel

RECRUITING

Related Publications (12)

• Yonatan-Leus R, Friedlander A, Sinai D, Weiser M, Lichtenberg P, Caspi A, Domany Y, Tzur Bitan D. Effectiveness of Two Hospitalization Alternatives Compared to Psychiatric Admission: An Ecological Longitudinal Study. Mental Illness. 2025;2025:3361455. doi:10.1155/mij/3361455.

  BACKGROUND

• Friedlander A, Tzur Bitan D, Lichtenberg P. The Soteria model: implementing an alternative to acute psychiatric hospitalization in Israel. Psychosis. 2022;14(2):99-108. doi:10.1080/17522439.2022.2057578.

  BACKGROUND

• Lichtenberg P. From the closed ward to Soteria: a professional and personal journey. Psychosis. 2017;9(4):369-375. doi:10.1080/17522439.2017.1373842.

  BACKGROUND

• Friedlander A, Oren S, Sinai D, Bitan DT, Yoffe R, Eitan R, Lichtenberg P. Psychiatric readmissions following Soteria versus traditional inpatient care: a propensity score-matched cohort study. Psychiatry Res. 2026 Oct;364:117263. doi: 10.1016/j.psychres.2026.117263. Epub 2026 Jun 5.

  PMID: 42322926 BACKGROUND

• Friedlander A, Sinai D, Zilcha-Mano S, Weiser M, Caspi A, Lichtenberg P, Amitai Z, Tzur Bitan D. Development of the Therapeutic Alliance in Alternative Settings to Psychiatric Hospitalization: An Open Comparative Study. Psychiatr Serv. 2024 Jun 1;75(6):549-555. doi: 10.1176/appi.ps.20230009. Epub 2024 Mar 19.

  PMID: 38500450 BACKGROUND

• Lichtenberg P, Friedlander A, Bergman-Levy T, Susser E, Yoffe R, Budowski D, Kodesh A, Tzur Bitan D, Weiser M. The Effect of Short-Term Acute Residential Treatment on Psychiatric Rehospitalization. J Nerv Ment Dis. 2023 Jun 1;211(6):467-470. doi: 10.1097/NMD.0000000000001600.

  PMID: 37252883 BACKGROUND

• Lichtenberg P. The residential care alternative for the acutely psychotic patient. Psychiatr Q. 2011 Dec;82(4):329-41. doi: 10.1007/s11126-011-9176-0.

  PMID: 21499788 BACKGROUND

• Lloyd-Evans B, Slade M, Jagielska D, Johnson S. Residential alternatives to acute psychiatric hospital admission: systematic review. Br J Psychiatry. 2009 Aug;195(2):109-17. doi: 10.1192/bjp.bp.108.058347.

  PMID: 19648539 BACKGROUND

• Ciompi L, Hoffmann H. Soteria Berne: an innovative milieu therapeutic approach to acute schizophrenia based on the concept of affect-logic. World Psychiatry. 2004 Oct;3(3):140-6.

  PMID: 16633478 BACKGROUND

• Calton T, Ferriter M, Huband N, Spandler H. A systematic review of the Soteria paradigm for the treatment of people diagnosed with schizophrenia. Schizophr Bull. 2008 Jan;34(1):181-92. doi: 10.1093/schbul/sbm047. Epub 2007 Jun 14.

  PMID: 17573357 BACKGROUND

• Bola JR, Mosher LR. Treatment of acute psychosis without neuroleptics: two-year outcomes from the Soteria project. J Nerv Ment Dis. 2003 Apr;191(4):219-29. doi: 10.1097/01.NMD.0000061148.84257.F9.

  PMID: 12695732 BACKGROUND

• Mosher LR. Soteria and other alternatives to acute psychiatric hospitalization: a personal and professional review. J Nerv Ment Dis. 1999 Mar;187(3):142-9. doi: 10.1097/00005053-199903000-00003.

  PMID: 10086470 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Hospitalization

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pesach Lichtenberg, MD

  Jerusalem Mental Health Center

  PRINCIPAL INVESTIGATOR

• Avraham Friedlander, PhD

  Jerusalem Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avraham Friedlander, PhD

CONTACT

+972506801173; avremi13@gmail.com

Pesach Lichtenberg, MD

CONTACT

+972508288100; Pesach.Lichtenberg@mail.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: At baseline, treatment allocation is concealed until informed consent and all initial assessments are completed. Participants, investigators conducting the baseline assessments, and outcome assessors do not know the future treatment assignment at that stage. After allocation, participants and treating staff know the assigned setting. At discharge and follow-up, outcome assessors remain blinded whenever feasible, although participants may inadvertently reveal their treatment setting. The success of masking is documented for each assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned to one of two parallel inpatient treatment settings: a closed unit incorporating Soteria elements or a conventional closed psychiatric ward. Random assignment is used whenever clinically and operationally feasible. Participants who cannot be randomized because of real-world clinical or administrative constraints may also be enrolled, with allocation method documented and addressed in separate and adjusted analyses.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 23, 2026
• Study Start: September 25, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning after publication of the primary study results and will remain available for at least 5 years thereafter.
• Access Criteria: De-identified data will be made available to qualified researchers upon reasonable written request to the study investigators. Requests must include a scientifically sound research proposal and specify the data requested and intended analyses. Access will be subject to approval by the study investigators and, when required, the relevant institutional or ethics authorities, and may require a data use agreement. Data may be used only for the approved research purpose and may not be used to attempt to identify individual participants.

Locations

IL (1)