A Closed Unit Incorporating Soteria Elements Versus a Conventional Closed Psychiatric Ward (CSCW)
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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Avraham Friedlander, PhD
- Telefonní číslo: +972506801173
- E-mail: avremi13@gmail.com
Studijní záloha kontaktů
- Jméno: Pesach Lichtenberg, MD
- Telefonní číslo: +972508288100
- E-mail: Pesach.Lichtenberg@mail.huji.ac.il
Studijní místa
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Jerusalem
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Jerusalem, Jerusalem, Izrael, 9387197
- Nábor
- Jerusalem Mental Health Center
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: 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.
Ostatní jména:
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Aktivní komparátor: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Psychotic Symptom Severity From Admission to Discharge
Časové okno: Baseline and at discharge, up to 180 days after admission
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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
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Therapeutic Alliance With the Treatment Team Assessed by the Session Alliance Inventory
Časové okno: At discharge, up to 180 days after admission
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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
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Satisfaction With Care Assessed by the Client Satisfaction Questionnaire-8
Časové okno: At discharge, up to 180 days after admission
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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
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Psychiatric Readmission Within One Year After Discharge
Časové okno: 1 year after discharge
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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
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Antipsychotic Medication Dose During Hospitalization
Časové okno: Baseline, Day 14 if still hospitalized, and at discharge, up to 180 days after admission
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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
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Anxiolytic Medication Dose During Hospitalization
Časové okno: Baseline, Day 14 if still hospitalized, and at discharge, up to 180 days after admission
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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
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Time to First Psychiatric Readmission Within One Year After Discharge
Časové okno: From discharge through 1 year after discharge
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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
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Legal Admission Status and Changes During Hospitalization
Časové okno: Baseline through discharge, up to 180 days after admission
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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
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Adverse Events and Interventions During Hospitalization
Časové okno: From admission through discharge, up to 180 days
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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
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Change in Sense of Dignity From Admission Through One-Year Follow-Up
Časové okno: Baseline, at discharge up to 180 days after admission, and 1 year after discharge
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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
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Change in Self-Stigma From Admission Through One-Year Follow-Up
Časové okno: Baseline, at discharge up to 180 days after admission, and 1 year after discharge
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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
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Discharge Reason and Post-Discharge Disposition
Časové okno: At discharge, up to 180 days after admission
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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
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Psychotic Symptom Severity at One-Year Follow-Up
Časové okno: Approximately one year after discharge
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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
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Antipsychotic Medication Dose at One-Year Follow-Up
Časové okno: 1 year after discharge
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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
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Personal Recovery at One-Year Follow-Up
Časové okno: Approximately one year after discharge
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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
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Anxiolytic Medication Dose at One-Year Follow-Up
Časové okno: 1 year after discharge
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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
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Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Retrospective Evaluation of Therapeutic Alliance at One-Year Follow-Up
Časové okno: Approximately one year after discharge
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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
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Retrospective Satisfaction With Inpatient Care at One-Year Follow-Up
Časové okno: Approximately one year after discharge
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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
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Length of Stay in the Study Inpatient Setting
Časové okno: From admission through discharge, up to 180 days
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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
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Mood Stabilizer Medication Dose From Admission Through One-Year Follow-Up
Časové okno: Baseline, Day 14 if still hospitalized, at discharge up to 180 days after admission, and 1 year after discharge
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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
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Antidepressant Medication Dose From Admission Through One-Year Follow-Up
Časové okno: Baseline, Day 14 if still hospitalized, at discharge up to 180 days after admission, and 1 year after discharge
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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
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Pesach Lichtenberg, MD, Jerusalem Mental Health Center
- Vrchní vyšetřovatel: Avraham Friedlander, PhD, Jerusalem Mental Health Center
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- JMHC-9-22
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
Data will be available beginning after publication of the primary study results and will remain available for at least 5 years thereafter.
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
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