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A Closed Unit Incorporating Soteria Elements Versus a Conventional Closed Psychiatric Ward (CSCW)

2026年9月17日 更新者:Avraham Friedlander、Jerusalem Mental Health Center

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.

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Avraham Friedlander, PhD
  • 电话号码:+972506801173
  • 邮箱:avremi13@gmail.com

研究联系人备份

学习地点

    • Jerusalem
      • Jerusalem、Jerusalem、以色列、9387197
        • 招聘中
        • Jerusalem Mental Health Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Closed Unit Incorporating Soteria Elements

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.

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.

其他名称:
  • Soteria-Informed Closed Unit
  • Closed Soteria
有源比较器:Conventional Closed Psychiatric Ward

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.

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.

其他名称:
  • Standard Closed Ward
  • Conventional Closed Ward

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Psychotic Symptom Severity From Admission to Discharge
大体时间: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.

Baseline and at discharge, up to 180 days after admission
Therapeutic Alliance With the Treatment Team Assessed by the Session Alliance Inventory
大体时间: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.

At discharge, up to 180 days after admission
Satisfaction With Care Assessed by the Client Satisfaction Questionnaire-8
大体时间: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.

At discharge, up to 180 days after admission
Psychiatric Readmission Within One Year After Discharge
大体时间: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.

1 year after discharge
Antipsychotic Medication Dose During Hospitalization
大体时间: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.

Baseline, Day 14 if still hospitalized, and at discharge, up to 180 days after admission
Anxiolytic Medication Dose During Hospitalization
大体时间: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.

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
大体时间: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.

From discharge through 1 year after discharge

次要结果测量

结果测量
措施说明
大体时间
Legal Admission Status and Changes During Hospitalization
大体时间:Baseline through discharge, up to 180 days after admission

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.

Baseline through discharge, up to 180 days after admission
Adverse Events and Interventions During Hospitalization
大体时间:From admission through discharge, up to 180 days

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.

From admission through discharge, up to 180 days
Change in Sense of Dignity From Admission Through One-Year Follow-Up
大体时间:Baseline, at discharge up to 180 days after admission, and 1 year after discharge

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.

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
大体时间:Baseline, at discharge up to 180 days after admission, and 1 year after discharge

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.

Baseline, at discharge up to 180 days after admission, and 1 year after discharge
Discharge Reason and Post-Discharge Disposition
大体时间:At discharge, up to 180 days after admission

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.

At discharge, up to 180 days after admission
Psychotic Symptom Severity at One-Year Follow-Up
大体时间:Approximately one year after discharge

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.

Approximately one year after discharge
Antipsychotic Medication Dose at One-Year Follow-Up
大体时间:1 year after discharge

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.

1 year after discharge
Personal Recovery at One-Year Follow-Up
大体时间:Approximately one year after discharge

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.

Approximately one year after discharge
Anxiolytic Medication Dose at One-Year Follow-Up
大体时间:1 year after discharge

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.

1 year after discharge

其他结果措施

结果测量
措施说明
大体时间
Retrospective Evaluation of Therapeutic Alliance at One-Year Follow-Up
大体时间:Approximately one year after discharge

Approximately one year after discharge, participants will retrospectively evaluate the therapeutic alliance they experienced with the inpatient treatment team using the adapted patient version of the six-item Session Alliance Inventory (SAI). 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, and the total score ranges from 6 to 42, with higher scores indicating a stronger perceived therapeutic alliance. One-year ratings will be compared between the two treatment settings and with ratings obtained at discharge.

Approximately one year after discharge
Retrospective Satisfaction With Inpatient Care at One-Year Follow-Up
大体时间:Approximately one year after discharge

Approximately one year after discharge, participants will retrospectively evaluate their satisfaction with the inpatient care they received using the eight-item Client Satisfaction Questionnaire (CSQ-8), adapted as needed to refer specifically to the previous hospitalization. Each item is rated on a 1-to-4 scale, and the total score ranges from 8 to 32, with higher scores indicating greater satisfaction with care. One-year ratings will be compared between the two treatment settings and with ratings obtained at discharge.

Approximately one year after discharge
Length of Stay in the Study Inpatient Setting
大体时间:From admission through discharge, up to 180 days

Length of stay will be calculated as the number of days from admission to the assigned study inpatient setting until discharge from that setting. Length of stay will be compared between the closed unit incorporating Soteria elements and the conventional closed psychiatric ward.

From admission through discharge, up to 180 days
Mood Stabilizer Medication Dose From Admission Through One-Year Follow-Up
大体时间:Baseline, Day 14 if still hospitalized, at discharge up to 180 days after admission, and 1 year after discharge

Mood stabilizer medication use and dosage will be assessed at baseline, on Day 14 for participants who remain hospitalized at that time, at discharge, and 1 year after discharge. Mood stabilizer doses will be converted to lithium-equivalent doses. Changes over time and differences between the two treatment settings will be explored.

Baseline, Day 14 if still hospitalized, at discharge up to 180 days after admission, and 1 year after discharge
Antidepressant Medication Dose From Admission Through One-Year Follow-Up
大体时间:Baseline, Day 14 if still hospitalized, at discharge up to 180 days after admission, and 1 year after discharge

Antidepressant medication use and dosage will be assessed at baseline, on Day 14 for participants who remain hospitalized at that time, at discharge, and 1 year after discharge. Antidepressant doses will be converted to fluoxetine-equivalent doses. Changes over time and differences between the two treatment settings will be explored.

Baseline, Day 14 if still hospitalized, at discharge up to 180 days after admission, and 1 year after discharge

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Pesach Lichtenberg, MD、Jerusalem Mental Health Center
  • 首席研究员:Avraham Friedlander, PhD、Jerusalem Mental Health Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月25日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2026年8月19日

首先提交符合 QC 标准的

2026年9月17日

首次发布 (实际的)

2026年9月23日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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.

IPD 共享时间框架

Data will be available beginning after publication of the primary study results and will remain available for at least 5 years thereafter.

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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