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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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

200

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Avraham Friedlander, PhD
  • 電話番号:+972506801173
  • メール:avremi13@gmail.com

研究連絡先のバックアップ

研究場所

    • Jerusalem
      • Jerusalem、Jerusalem、イスラエル、9387197
        • 募集
        • Jerusalem Mental Health Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

男

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

他の名前:
  • Soteria-Informed Closed Unit
  • Closed Soteria
アクティブコンパレータ: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.

他の名前:
  • Standard Closed Ward
  • Conventional Closed Ward

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Psychotic Symptom Severity From Admission to Discharge
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Legal Admission Status and Changes During Hospitalization
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Retrospective Evaluation of Therapeutic Alliance at One-Year Follow-Up
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

協力者

捜査官

  • 主任研究者:Pesach Lichtenberg, MD、Jerusalem Mental Health Center
  • 主任研究者:Avraham Friedlander, PhD、Jerusalem Mental Health Center

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年9月25日

一次修了 (推定)

2028年5月1日

研究の完了 (推定)

2029年6月1日

試験登録日

最初に提出

2026年8月19日

QC基準を満たした最初の提出物

2026年9月17日

最初の投稿 (実際)

2026年9月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月23日

QC基準を満たした最後の更新が送信されました

2026年9月17日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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