The Effect of Early Intervention on the Incidence of Posttraumatic Stress Disorder After Intensive Care Hospitalization Due to Sepsis
研究概览
详细说明
In recent years, there has been a significant increase in the survival rate of patients hospitalized in intensive care, due in part to improved capabilities in diagnosing and treating severe infections and sepsis, the use of broad-spectrum antibiotics, and the development of advanced life-support technologies. However, alongside this rise in survival, it has become evident that many patients continue to suffer from long-term complications following their discharge from intensive care. This phenomenon is described in the literature as Post-Intensive Care Syndrome (PICS) and encompasses physical, cognitive, and psychological impairments that develop or persist after an intensive care stay.
Among the prominent psychological consequences following an intensive care unit (ICU) stay is post-traumatic stress disorder (PTSD), alongside symptoms of anxiety and depression. Various studies indicate that a significant proportion (9-27%) of ICU survivors develop post-traumatic symptoms; while these may appear during the hospital stay itself, they sometimes develop or worsen after discharge. Potential risk factors for the development of these symptoms include traumatic experiences during the hospital stay, delirium, prolonged mechanical ventilation, exposure to certain medications, and the severity of the underlying illness.
Patients hospitalized in the ICU due to sepsis constitute a particularly high-risk population for developing these symptoms, given the severity of the illness, the duration of the hospital stay, and exposure to numerous invasive procedures. Beyond the psychological impact, post-traumatic symptoms can significantly affect patients' quality of life, daily functioning, and recovery process following hospital discharge.
Despite the prevalence of this phenomenon, most medical centers currently lack a structured model for screening and early intervention among patients discharged from the ICU. Most research in this field focuses on identifying the phenomenon or describing its risk factors, whereas data regarding the efficacy of early interventions to prevent PTSD following ICU hospitalization remain limited.
In light of this, there is a need to evaluate the feasibility of an early intervention model for patients discharged from the intensive care unit following hospitalization for sepsis. Such an intervention could help identify at-risk patients early, reduce the severity of psychological symptoms, and improve their quality of life after hospital discharge.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Daniel Leshin Carmel, MD
- 电话号码:+972525253037
- 邮箱:danielles@bmc.gov.il
研究联系人备份
- 姓名:Pnina Nir
- 邮箱:pninan@bmc.gov.il
学习地点
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Ashkelon、以色列
- 招聘中
- Barzilai Medical Center
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接触:
- Daniel Leshin-Carmel, MD
- 电话号码:+972525253037
- 邮箱:danielles@bmc.gov.il
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接触:
- pnina nir, study coordinator
- 邮箱:pninan@bmc.gov.il
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Discharged from ICU due to sepsis
- Age over 18 years old
Exclusion Criteria:
- Age under 18 years old
- Lack of consent
- Dementia/ mental retardation or any other condition due to which the patient cannot fill the questionnaires or participate in the psychiatric interview.
- A cute psychosis or other psychiatric condition nesiccating psychiatric treatment.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Early psychiatric intervention
Interventional arm.
Early intervention after discharge from ICU.
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Psychiatric interview for 45 minutes
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无干预:No intervention
Observational arm.
No intervention after discharge from ICU.
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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 |
|---|---|---|
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PTSD risk according to PCL-5
大体时间:30 days
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Post Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5).
The PCL-5 is widely used in clinical and research settings to screen for PTSD, assess symptom severity, and monitor treatment progress over time.
Total scores can range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
In addition to a raw score being presented, a mean score is also computed, which is the subscale score divided by the number of items within that subscale.
The average score can help determine elevated symptom clusters when comparing each of the four subscales.
These scores range between 0 to 4, where higher scores represent higher severity.
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30 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Depression risk
大体时间:30 days
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Patient Health Questionnaire-9 is a validated, 9-question tool to assess for the degree of depression present in an individual.
The total score ranges from 0 to 27.
The higher the score is the more severe the depression is.
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30 days
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General well being
大体时间:30 days
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This questionnaire is designed to measure general well-being, including negative well-being, energy and positive well-being.
The Well-Being Questionnaire (W-BQ) was first developed in the early 1980s as a 22-item measure.
The range is from 0 to 110, the higher the score the better is the general well being.
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30 days
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合作者和调查者
调查人员
- 首席研究员:Daniel Leshin Carmel, MD、Barzilai Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 0041-26-BRZ
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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