Evaluate the Effectiveness for Long-term Consequences of COVID-19 of Mindfulness-based Stress Reduction (MBSR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Chronic pain
研究概览
简要总结
The consequences of the Intensive Care Unit and the Covid-19 disease are still uncertain. However, many studies are bringing out often psychological and dramatic consequences for many COVID-survivor patients.
Among the ex-covid patients discharged from our Intensive Care Unit and with at least one covid-related psychological consequence, we want to evaluate the effectiveness for long-term consequences of COVID-19 of mindfulness-based stress reduction (MBSR) or usual care.
详细描述
Randomized controlled clinical study. All patients who survived COVID-19 and discharged from the intensive care unit of the Lecco hospital will be enrolled if present: chronic pain, anxiety, depression and/or insomnia in pharmacological therapy A group of patients will be observed during 12 months and evaluated with rating scales for chronic pain, anxiety, depression and insomnia.
The second (experimental) group will receive psychotherapy (mindfulness-based stress reduction and cognitive behavioral therapy) in addition to the pharmacological therapy
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intensive care survivors
- •Surviving COVID-19 patients
- •Patients with Chronic Pain Anxiety Depression and/or Insomnia in drug therapy
排除标准
- •Patients with Chronic Pain Anxiety Depression and/or Insomnia NOT in drug therapy
- •Patients not hospitalized in intensive care for COVID-19
结局指标
主要结局
Chronic pain
时间窗: 6 months and 1 year
pain that persists or recurs for longer than 3 months, and it exerts an enormous personal and economic burden, affecting more than 30% of people worldwide
Insomnia
时间窗: 6 months and 1 year
a common sleep disorder that can make it hard to fall asleep, hard to stay asleep, or cause you to wake up too early and not be able to get back to sleep
Depression
时间窗: 6 months and 1 year
a depressed mood or loss of pleasure or interest in activities for long periods of time
Anxiety
时间窗: 6 months and 1 year
an emotion characterized by feelings of tension, worried thoughts, and physical changes like increased blood pressure
次要结局
未报告次要终点
研究者
Vincenzo Damico
Registered Nurse (RN), Doctor of Philosophy (PhD), Department of Anesthesia and Critical Care
Azienda Socio Sanitaria Territoriale di Lecco