Psychiatric Hospitalization in a Closed Unit Incorporating Soteria Elements Versus a Conventional Closed Psychiatric Ward: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Psychotic Symptom Severity From Admission to Discharge
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
At baseline, treatment allocation is concealed until informed consent and all initial assessments are completed. Participants, investigators conducting the baseline assessments, and outcome assessors do not know the future treatment assignment at that stage. After allocation, participants and treating staff know the assigned setting. At discharge and follow-up, outcome assessors remain blinded whenever feasible, although participants may inadvertently reveal their treatment setting. The success of masking is documented for each assessment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Inpatient Care in a Closed Unit Incorporating Soteria Elements (Other)
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.
干预措施: Conventional Closed Psychiatric Inpatient Care (Other)
结局指标
主要结局
Change in Psychotic Symptom Severity From Admission to Discharge
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Legal Admission Status and Changes During Hospitalization(Baseline through discharge, up to 180 days after admission)
- Adverse Events and Interventions During Hospitalization(From admission through discharge, up to 180 days)
- Change in Sense of Dignity From Admission Through One-Year Follow-Up(Baseline, at discharge up to 180 days after admission, and 1 year after discharge)
- Change in Self-Stigma From Admission Through One-Year Follow-Up(Baseline, at discharge up to 180 days after admission, and 1 year after discharge)
- Discharge Reason and Post-Discharge Disposition(At discharge, up to 180 days after admission)
- Psychotic Symptom Severity at One-Year Follow-Up(Approximately one year after discharge)
- Antipsychotic Medication Dose at One-Year Follow-Up(1 year after discharge)
- Personal Recovery at One-Year Follow-Up(Approximately one year after discharge)
- Anxiolytic Medication Dose at One-Year Follow-Up(1 year after discharge)
研究者
Avraham Friedlander
Principal Investigator
Jerusalem Mental Health Center