Effect of Mindfulness-Based Protocols on Psychological Parameters and Biological Markers in Populations Exposed to Conditions of Persistent Distress: a Randomized Controlled Trial in Healthcare Workers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cortisol level
研究概览
简要总结
The goal of this clinical trial is to learn if a Mindfulness-Based Stress Reduction (MBSR) training can improve the mental health and well-being of healthcare professionals (HCPs) exposed to prolonged severe stress conditions.
The main questions it aims to answer are:
- Does an 8-week MBSR training lower the cortisol levels of HCPs exposed to prolonged severe stress conditions?
- Does an 8-week MBSR training modify the psychological condition of HCPs exposed to prolonged severe stress conditions? Researchers will compare an 8-week MBSR training to no-training to see if MBSR training works to improve the mental health and well-being of HCPs.
Participants will:
- Partecipate or not partecipate to the MBSR training for 8 weeks
- Visit the clinic at baseline, after the 8-week intervention (T1), and at follow-up after 6 months for checkups and tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthcare workers belonging to the Dept. of Mental Health, Onco-hematology, Medicine, and Intensive Care, who are frequently exposed to situations of severe and prolonged stress
- •age between 18 and 65 years
- •informed consent
排除标准
- •Use of psychotropic drugs in the previous 2 months
- •Previous mindfulness training
- •Medical conditions preventing participation in group sessions
- •Current pregnancy.
结局指标
主要结局
Cortisol level
时间窗: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
To assess cortisol levels, at baseline (T0), T1, and T2, saliva samples will be collected using Salivettes (Sarstedt) 30 minutes after waking up. Participants will be instructed not to drink, eat, chew gum, or brush their teeth in the 30 minutes preceding the sample collection. To collect the saliva, participants will be advised to rinse their mouth with water for 30 seconds, wait 10 minutes, and then remove the swab from the Salivette and chew it for about 2 minutes to stimulate salivation. The swab will be reinserted into the Salivette, frozen at -20°C and stored at the Laboratory of the AUSL Piacenza Centre. Then, sample will be shipped to the University of Siena for further analysis. Upon arrival at the laboratory, the samples will be thawed and centrifuged at 2000 × g for 5 minutes at 4°C. Salivary cortisol levels will be assayed by an Enzyme Immunoassay kit (Arbor Assays Inc., Ann Arbor, Michigan, USA).
次要结局
- Psychometric evaluation of stress and burnout by Positive Meaning subscale of the Italian Cardiologists' Undetected Distress Study (IANUS)(At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2))
- Psychometric evaluation of stress and burnout by Relational Difficulty subscale of the Italian Cardiologists' Undetected Distress Study (IANUS)(At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2))
- Psychometric evaluation of stress and burnout by the Perceived Stress Scale (PSS)(At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2))
- Psychometric evaluation of stress and burnout by Job Strain subscale of the Italian Cardiologists' Undetected Distress Study (IANUS)(At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2))
- Psychometric evaluation of awareness and mindfulness skills by the Mindfulness Awareness Attention Scale (MAAS)(At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2))
- Psychometric evaluation of psychophysiological distress and quality of life by the Psychological General Well-Being Short (PGWB-S)(At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2))
- Psychometric evaluation of stress and burnout by Emotional Fatigue subscale ofthe Italian Cardiologists' Undetected Distress Study (IANUS)(At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2))