Mind Body Intervention for Long COVID
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Somatic Symptom Score-8 (SSS-8)
研究概览
简要总结
The goal of this study is to determine if a mind-body intervention can help people suffering from symptoms associated with Long COVID. The study is a randomized trial examining the effectiveness of a mind body intervention in reducing somatic symptoms from Long COVID in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates individual somatic complaints and improves daily functioning, relative to usual care and the active control
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
- Double (Participant, Outcomes Assessor)
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
- 否
入选标准
- •Adult (≥ 18 years of age)
- •Infection with Sars-COV2 (i. e., positive antibody, antigen, or PCR testing)
- •Symptoms attributed only to COVID-19 and not to known comorbid disease (e.g., other infections, cancer, etc)
- •A somatic symptom score ≥ 10 on the SSS-8 questionnaire with involvement of at least 3 domains
- •Symptoms present at least 3 day a week for a minimum of 3 months
- •Willingness to engage in a Mind-Body intervention
排除标准
- •Clear diagnosis of physical disease (e.g. lung fibrosis, myocarditis) not inclusive of non-specific findings such as mild arthritis
- •Hospitalization in an intensive care unit for acute COVID-19 infections
- •Age greater than 65 years
- •Diagnosis of dementia or similar cognitive impairment
- •Active addiction disorder (e.g. cocaine) that would interfere with study participation
- •Major psychiatric comorbidity (e.g., schizophrenia). Mild to moderate anxiety and depression are not considered in this category
研究组 & 干预措施
Usual Care
Mind Body Intervention #1
干预措施: Mind Body Intervention #1 (Behavioral)
Mind Body Intervention #2
干预措施: Mind Body Intervention #1 (Behavioral)
结局指标
主要结局
Somatic Symptom Score-8 (SSS-8)
时间窗: Baseline, 4 weeks, 8 weeks, 13 weeks
Survey questions pertain to pain, the gastrointestinal system, fatigue, dizziness, and cardiovascular complaints. Range of 0-32, with higher scores indicating higher levels of discomfort.
次要结局
- Short Form Brief Pain Inventory (BPI)(Baseline, 4 weeks, 8 weeks, 13 weeks)
- Generalized Anxiety Disorder form 7 (GAD-7)(Baseline and 13 weeks)
- Fatigue Severity Scale (FSS)(Baseline, 4 weeks, 8 weeks, 13 weeks)
- Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS)(Baseline, 4 weeks, 8 weeks, 13 weeks)
- The Multidimensional Dyspnea Profile (MDP)(Baseline, 4 weeks, 8 weeks, 13 weeks)
- End of study measurements(13 weeks)
- Pain Anxiety Symptom Score-20 (Pass-20)(Baseline, 4 weeks, 8 weeks, 13 weeks)
- Patient Reported Outcomes Measurement Information System Survey for Cognitive Function (PROMIS SF v2.0 cognitive function 8a)(Baseline, 4 weeks, 8 weeks, 13 weeks)
研究者
Michael Donnino
Physician
Beth Israel Deaconess Medical Center