Application of a Telemedicine Brief Mindfulness Intervention in Post-COVID-19: a Pilot Randomized and Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Symptoms of Post-Traumatic Stress Disorder (PTSD)
研究概览
简要总结
Background: Several studies suggest that SARS survivors still presented with high levels of psychological distress overall at 1, 3, 12, and 18 months after hospital discharge. Nonetheless, there are no data available in the literature regarding the implementation of interventions that are psychological interventions, let alone specific ones. In particular, the practice of mindfulness, formalized in the protocols such as Mindfulness Based Stress Reduction (MBSR) and Mindfulness Based Cognitive Therapy (MBCT). Based Cognitive Therapy (MBCT), have proved to be very effective in reducing stress related to chronic conditions and of depression. However, these protocols typically require a high level of engagement for participants, which is why, in the present exploratory study, the investigators opted to evaluate the implementation of a Mindfulness-based protocol that is short and less intense, but which has shown good results on health-related outcomes, even with a single session.
Objectives: In this perspective, it becomes important to detect the presence of psychological distress in those who have contracted COVID-19 and are now undertaking a rehabilitation program, from the perspective of promoting well-being and prevention of possible aggravation if not prolongation of mental suffering in the long term.
Study Design: Randomized and Controlled (RCT), two-arm pilot study with three data captures (baseline=T0, 3 weeks=T1, 3 months=T2).
Participants: People who have previously tested positive for COVID-19, now negative and hospitalized at the IRCCS Santa Maria Nascente of the Fondazione Don Carlo Gnocchi in Milan.
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
- •Previously positive for COVID-19 and now negative and undergoing treatment Pulmonary rehabilitation;
- •Compatibility to participate in the study as judged by the physician;
- •Able to provide Informed Consent.
排除标准
- •The physician's unfavorable opinion of inclusion in the study because he or she is unable to provide Informed Consent;
- •Patients with lung cancer;
- •Documented psychiatric disorders;
- •Immunodepression;
- •Patients with terminal or neurodegenerative diseases (e.g., other forms of cancer, Amyotrophic Lateral Sclerosis (ALS)).
结局指标
主要结局
Symptoms of Post-Traumatic Stress Disorder (PTSD)
时间窗: Change from baseline at 3 weeks and at 3 months
Symptoms of Post-Traumatic Stress Disorder (PTSD) as measured by the Impact of Event Scale (IES) (Horowitz, Wilner, \& Alvarez, 1979). The revised version of the Impact of Event Scale (IES-r) has seven additional questions and a scoring range of 0 to 88. On this test, scores that exceed 24 can be quite meaningful. High scores have the following associations.
次要结局
- Depression(Change from baseline at 3 weeks and at 3 months)
- Changes with respect to respiratory function(Change from baseline at 3 weeks and at 3 months)
- Changes in arterial blood gas analysis (ABG)(Change from baseline at 3 weeks and at 3 months)
- CBC, basal cortisolemia ACTH, CPK(Change from baseline at 3 weeks and at 3 months)
- Anxiety 2006), at baseline, 3 weeks, 3 months after recruitment.(Change from baseline at 3 weeks and at 3 months)
- Psychological distress(Change from baseline at 3 weeks and at 3 months)
- Counterfactual thinking and peritraumatic emotions of guilt, shame, and fear in relation to the events stressful events(Change from baseline at 3 weeks and at 3 months)
- Changes in oxygen saturation (SpO2)(Change from baseline at 3 weeks and at 3 months)
- Change in CBC, ferritin, fibrinogen, creatinine, electrolytes, transaminases, d-dimer values, immunoelectrophoresis, baseline cortisolemia ACTH, CPK, COVID-19-related serological values of IgG and IgM.(Change from baseline at 3 weeks and at 3 months)
- Well-being(Change from baseline at 3 weeks and at 3 months)
研究者
Paolo Banfi
MD, Chief of the Cardio-Respiratory Rehabilitation
Fondazione Don Carlo Gnocchi Onlus