Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- prevalence of post traumatic stress syndrome
研究概览
简要总结
Psychological impact of intensive care hospitalization for patients has been demonstrated during the last few years: anxiety, depression and post traumatic stress disorder. Hospitalizations during COVID-19 pandemic have been marked by factors such as confinement forbidding family members visits, stress on intensive care unit ...Those factors may have a psychological impact added to factors of long hospitalization and prolonged mechanical ventilation.
For all these reasons the investigators fear that patients hospitalized in intensive care during COVID-19 pandemic develop psychological trouble with an increased risk for those who experienced COVID-19 infection. The hypothesis therapy group added to standard care might have a positive impact on psychological troubles such as anxiety, depression and post traumatic stress disorder for patients who have been hospitalized in intensive care during COVID-19 pandemic.
The investigators will compare two groups:
- group receiving standard of care
- group receiving standard of care and therapy group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old and older
- •hospitalized at least 72h in intensive care during COVID-19 pandemic crisis
- •out of intensive care for at least 2 months and maximum 6 months
- •psychological evaluation done according to local practice and standard of care
- •speaking french
- •patient coming alone to the therapy group
- •patient agree to respect confidentiality rules and demonstrating goodwill with others participants
- •patient comite to respecting barriers rules against COVID-19
- •affiliated to social security system
- •no juridic protection engaged
排除标准
- •presenting psychological disease
- •drug addiction
- •participation to other interventional clinical trial
结局指标
主要结局
prevalence of post traumatic stress syndrome
时间窗: 12 months after intensive care hospitalization
the aim is to compare the prevalence of post traumatic stress syndrome between both groups 12 months after exiting intensive care unit
次要结局
未报告次要终点