Mind Body Intervention for COVID-19 Long Haul Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in somatic symptom severity
研究概览
简要总结
The present study is a feasibility study in which we will determine if a mind-body program that we have previously developed for chronic back pain can improve the multiple somatic complaints associated with the COVID Long Haul Syndrome.
详细描述
This study is a pilot and feasibility study to determine if a mind-body program that we have previously developed for chronic back pain can improve the multiple somatic complaints associated with the COVID Long Haul Syndrome in patients without evidence of ongoing tissue injury. We will perform a 12-week intervention consisting of a series of classes which will focus on knowledge therapy, desensitization, emotional expression, and stress reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient ≥ 18 years old
- •New symptoms attributed to the post-covid long-haul syndrome (extremity pain, dyspnea, headaches, chest pain, fatigue) occurring after an acute phase of COVID19
- •Minimum of at least 12 weeks after the end of the acute phase of COVID-19 infection
- •Persistence of symptoms for a least 1 month with no identified other organic etiology
- •Score ≥ 3 or more on the SSS-8 score
- •Symptoms present for a minimum of 4 days a week
- •Willingness to consider mind-body intervention
排除标准
- •Patients < 18 years of age
- •Patients > 60 years of age
- •Diagnosed (non-COVID-19) organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome (note that pain related to disc disease is not an exclusion unless there are neurological impairments).
- •Patients with previous severe COVID-19 disease, defined as those who had been admitted to the ICU or have objective evidence of ongoing organ injury (e.g., persistent chest radiographic abnormalities or myocarditis)
- •Identified lung or cardiac injury in subjects with chest pain or dyspnea (e.g., chest radiograph abnormalities, cardiac ultrasound showing myocarditis or depressed ejection fraction )
- •Patients with a diagnosis of significant psychiatric comorbidities such as schizophrenia or dementia
结局指标
主要结局
Change in somatic symptom severity
时间窗: Baseline, 4, 8, and 13 weeks
Will be assessed using the Somatic Symptom Scale-8 (SSS-8). The minimum score is 0 and the maximum 32, with higher values indicating a worse outcome (more severe symptoms)
次要结局
- Fatigue(Baseline 4, 8, 13 weeks)
- Dyspnea(Baseline 4, 8, and 13 weeks)
- Pain-related Anxiety(Baseline 4, 8, 13 weeks)
- Physical Functioning(Baseline, 4, 8, and 13 weeks.)
- Average Pain(Baseline, 4, 8, and 13 weeks)
- Pain intensity(Baseline 4, 8, and 13 weeks)
- Brain Fog(Baseline, 4, 8, and 13 weeks)
研究者
Michael Donnino
Professor of Emergency Medicine
Beth Israel Deaconess Medical Center