Psychotic DisordersCSCWNCT07836348
A Closed Unit Incorporating Soteria Elements Versus a Conventional Closed Psychiatric Ward
A study testing Inpatient Care in a Closed Unit Incorporating Soteria Elements and Conventional Closed Psychiatric Inpatient Care in people with Psychotic Disorders, run by Jerusalem Mental Health Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Inpatient Care in a Closed Unit Incorporating Soteria Elements and Conventional Closed Psychiatric Inpatient Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Sep 2025to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Jerusalem Mental Health Center
Jerusalem, Jerusalem, 9387197
About this study
Official title: Psychiatric Hospitalization in a Closed Unit Incorporating Soteria Elements Versus a Conventional Closed Psychiatric Ward: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
To support retention at the one-year follow-up assessment, participants who attend the Jerusalem Mental Health Center in person to complete the follow-up assessments will receive 100 New Israeli Shekels (approximately 33 United States dollars) as compensation for their time and participation in the follow-up visit.
- Conditions
- Psychotic Disorders
- Being tested
- Inpatient Care in a Closed Unit Incorporating Soteria Elements, Conventional Closed Psychiatric Inpatient Care
- Keywords
- Acute Psychosis, Soteria, Closed Psychiatric Ward, Locked Psychiatric Unit, Psychiatric Hospitalization, Recovery-Oriented Care
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient Care in a Closed Unit Incorporating Soteria ElementsOther
Also called Soteria-Informed Closed Unit, Closed Soteria
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.
Conventional Closed Psychiatric Inpatient CareOther
Also called Standard Closed Ward, Conventional Closed Ward
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Closed Psychiatric Inpatient Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From discharge through 1 year after discharge
Secondary outcomes (9)
Legal Admission Status and Changes During Hospitalization
Legal admission status will be recorded at admission and throughout hospitalization. Status will be categorized as voluntary admission or involuntary admission under a legal hospitalization order. Changes in legal status during hospitalization will be recorded, including transition from involuntary to voluntary status or from voluntary to involuntary status. The time in days from admission to the first change in legal status, as well as the direction and number of status changes, will be compared between the two treatment settings.
Measured: Baseline through discharge, up to 180 days after admission
Adverse Events and Interventions During Hospitalization
Adverse events occurring during hospitalization will be recorded, including the date and type of each event and the intervention used in response. The number and types of adverse events and related interventions will be compared between the two treatment settings.
Measured: From admission through discharge, up to 180 days
Change in Sense of Dignity From Admission Through One-Year Follow-Up
Sense of dignity will be assessed using the 15-item Sense of Dignity Scale. Each item is rated on a 1-to-4 scale, and the total score is calculated by summing the 15 items, with higher scores indicating a greater sense of dignity, self-worth, autonomy, and meaning. Scores will be assessed at admission, discharge, and approximately one year after discharge. Changes over time and differences between the two treatment settings will be examined.
Measured: 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
Self-stigma will be assessed using the 40-item Self-Stigma of Mental Illness Scale (SSMIS). The scale comprises four 10-item subscales: awareness of public stereotypes, agreement with public stereotypes, application of stereotypes to oneself, and harm to self-esteem. Each item is rated on a 1-to-9 scale. A separate score will be calculated for each subscale, with higher scores indicating greater endorsement of the corresponding stage of self-stigma. Scores will be assessed at admission, discharge, and approximately one year after discharge. Changes over time and differences between the two treatment settings will be examined.
Measured: Baseline, at discharge up to 180 days after admission, and 1 year after discharge
Discharge Reason and Post-Discharge Disposition
At discharge, the reason for discharge and the participant's planned post-discharge disposition will be recorded. Post-discharge disposition will include the planned living arrangement and the planned psychiatric or psychosocial follow-up setting. The distribution of discharge reasons, residential destinations, and planned follow-up treatment settings will be compared between the two treatment groups.
Measured: At discharge, up to 180 days after admission
Psychotic Symptom Severity at One-Year Follow-Up
Psychotic symptom severity will be assessed approximately one year after discharge using the six-item Positive and Negative Syndrome Scale (PANSS-6). The scale 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. PANSS-6 scores at one-year follow-up will be compared between the two treatment settings and with scores obtained at admission and discharge.
Measured: Approximately one year after discharge
Antipsychotic Medication Dose at One-Year Follow-Up
Antipsychotic medication use and dosage will be assessed approximately one year after discharge. Antipsychotic doses will be converted to olanzapine-equivalent doses. Medication dose at one-year follow-up will be compared between the two treatment settings and with doses recorded at baseline, Day 14 for participants who remained hospitalized at that time, and discharge.
Measured: 1 year after discharge
Personal Recovery at One-Year Follow-Up
Personal recovery will be assessed approximately one year after discharge using the 24-item Recovery Assessment Scale (RAS-24). Each item is rated on a 1-to-5 scale. Higher scores indicate a stronger subjective sense of recovery, including greater hope, goal orientation, willingness to seek help, reliance on others, and reduced domination by symptoms. Scores will be compared between the two treatment settings.
Measured: Approximately one year after discharge
Anxiolytic Medication Dose at One-Year Follow-Up
Anxiolytic medication use and dosage will be assessed approximately one year after discharge. Anxiolytic doses will be converted to diazepam-equivalent doses. Medication dose at one-year follow-up will be compared between the two treatment settings and with doses recorded at baseline, Day 14 for participants who remained hospitalized at that time, and discharge.
Measured: 1 year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start25 Sep 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jerusalem Mental Health Center
- Sponsor type
- Other government
- Collaborators
- Moshe Hess Amuta
- Responsible party
- Principal investigator, Avraham Friedlander, Jerusalem Mental Health Center
- Investigators
- Pesach Lichtenberg, MD, Principal investigator, Jerusalem Mental Health CenterAvraham Friedlander, PhD, Principal investigator, Jerusalem Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836348
- Sponsor's protocol ID
- JMHC-9-22
- Acronym
- CSCW
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in study publications may be shared. Shared data may include demographic and clinical variables, treatment allocation, symptom measures, medication data, patient-reported outcome measures, hospitalization characteristics, and follow-up outcomes. Direct identifiers and information that could reasonably permit participant identification will not be shared.
Publications
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.
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.
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.
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.
PubMed 42322926Friedlander 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.
PubMed 38500450Lichtenberg 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.
PubMed 37252883Lichtenberg 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.
PubMed 21499788Lloyd-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.
PubMed 19648539Ciompi 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.
PubMed 16633478Calton 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.
PubMed 17573357Bola 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.
PubMed 12695732Mosher 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.
PubMed 10086470
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Hospitalization in a Closed Unit Incorporating Soteria Elements Versus a Conventional Closed Psychiatric Ward: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07836348
- Acronym / sponsor ID
- CSCW / JMHC-9-22
- Conditions
- Psychotic Disorders
- Keywords
- Acute Psychosis, Soteria, Closed Psychiatric Ward, Locked Psychiatric Unit, Psychiatric Hospitalization, Recovery-Oriented Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jerusalem Mental Health CenterOther government
- Collaborators
- Moshe Hess Amuta
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To support retention at the one-year follow-up assessment, participants who attend the Jerusalem Mental Health Center in person to complete the follow-up assessments will receive 100 New Israeli Shekels (approximately 33 United States dollars) as compensation for their time and participation in the follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Closed Unit Incorporating Soteria Elements | Experimental | Other: Inpatient Care in a Closed Unit Incorporating Soteria ElementsParticipants 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. |
| Conventional Closed Psychiatric Ward | Active comparator | Other: Conventional Closed Psychiatric Inpatient CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inpatient Care in a Closed Unit Incorporating Soteria ElementsAlso: Soteria-Informed Closed Unit, Closed SoteriaA 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. | Other | Closed Unit Incorporating Soteria Elements |
| Conventional Closed Psychiatric Inpatient CareAlso: Standard Closed Ward, Conventional Closed WardStandard psychiatric inpatient treatment provided in a conventional closed ward, including psychiatric and nursing care, medication management, multidisciplinary treatment, structured supervision, and routine ward procedures. | Other | Conventional Closed Psychiatric Ward |
Primary outcome
Change in Psychotic Symptom Severity From Admission to Discharge
Time frame: Baseline and at discharge, up to 180 days after admission
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.
Therapeutic Alliance With the Treatment Team Assessed by the Session Alliance Inventory
Time frame: At discharge, up to 180 days after admission
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.
Satisfaction With Care Assessed by the Client Satisfaction Questionnaire-8
Time frame: At discharge, up to 180 days after admission
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.
Psychiatric Readmission Within One Year After Discharge
Time frame: 1 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.
Antipsychotic Medication Dose During Hospitalization
Time frame: Baseline, Day 14 if still hospitalized, and at discharge, up to 180 days after admission
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.
Anxiolytic Medication Dose During Hospitalization
Time frame: Baseline, Day 14 if still hospitalized, and at discharge, up to 180 days after admission
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.
Time to First Psychiatric Readmission Within One Year After Discharge
Time frame: From discharge through 1 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.
9 secondary outcomes
Legal Admission Status and Changes During Hospitalization
Time frame: Baseline through discharge, up to 180 days after admission
Adverse Events and Interventions During Hospitalization
Time frame: From admission through discharge, up to 180 days
Change in Sense of Dignity From Admission Through One-Year Follow-Up
Time frame: 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
Time frame: Baseline, at discharge up to 180 days after admission, and 1 year after discharge
Discharge Reason and Post-Discharge Disposition
Time frame: At discharge, up to 180 days after admission
Psychotic Symptom Severity at One-Year Follow-Up
Time frame: Approximately one year after discharge
Antipsychotic Medication Dose at One-Year Follow-Up
Time frame: 1 year after discharge
Personal Recovery at One-Year Follow-Up
Time frame: Approximately one year after discharge
Anxiolytic Medication Dose at One-Year Follow-Up
Time frame: 1 year after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- BackgroundYonatan-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.
- BackgroundFriedlander 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.
- BackgroundLichtenberg 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: PubMed 42322926Friedlander 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.
- Background: PubMed 38500450Friedlander 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.
- Background: PubMed 37252883Lichtenberg 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.
- Background: PubMed 21499788Lichtenberg 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.
- Background: PubMed 19648539Lloyd-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.
- Background: PubMed 16633478Ciompi 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.
- Background: PubMed 17573357Calton 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.
- Background: PubMed 12695732Bola 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.
- Background: PubMed 10086470Mosher 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in study publications may be shared. Shared data may include demographic and clinical variables, treatment allocation, symptom measures, medication data, patient-reported outcome measures, hospitalization characteristics, and follow-up outcomes. Direct identifiers and information that could reasonably permit participant identification will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pesach Lichtenberg, MD principal investigator
Jerusalem Mental Health Center
Avraham Friedlander, PhD principal investigator
Jerusalem Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inpatient Care in a Closed Unit Incorporating Soteria Elements and Conventional Closed Psychiatric Inpatient Care in people with Psychotic Disorders, run by Jerusalem Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avraham Friedlander, PhD (+972506801173, avremi13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychotic Symptom Severity From Admission to Discharge (time frame: Baseline and at discharge, up to 180 days after admission). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07836348, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.