ChiCTR2300068084
尚未招募
不适用
Effects of stand-alone mindfulness practices for people with long COVID-19 symptoms: A randomized controlled trial
Health and Medical Research Fund, Food and Health Bureau, HKSAR1 个研究点 分布在 1 个国家开始时间: 2023年2月6日最近更新:
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Health and Medical Research Fund, Food and Health Bureau, HKSAR
- 试验地点
- 1
- 主要终点
- the self-report COVID-19 Yorkshire Rehabilitation Scale (C19-YRS)
概览
简要总结
This study aims to evaluate the effects of mindfulness practices as a standalone intervention (an 8-week 1.25-hour online mindfulness practices class led by a mindfulness teacher, together with practice audios and a self-help booklet) among people with long COVID-19 symptoms, comparing to a health education control through a randomized controlled trial design. The primary objective is to:
- Evaluate the effectiveness of the mindfulness practices in improving self-reported severity of long COVID-19 symptoms, functional disability, and overall health immediately after the 8-week intervention (primary time point) and 3 months after the intervention, comparing to the health education control. The secondary objectives are to:
- Evaluate the effectiveness of the mindfulness practices in reducing proportions of participants having 1+, 3+, and 5+ symptoms in the intervention group immediately and 3 months after the 8-week intervention, compared to the control.
- Evaluate the effectiveness of mindfulness practices in reducing depression, anxiety, health care utilization, and improving mindfulness and health-related quality of life immediately and 3 months after the intervention, compared to the control.
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 100（—）
- 性别
- All
入选标准
- •Aged 18 years or above,
- •With any self-reported long COVID-19 symptoms listed in the recent systematic review by Michelen and colleagues at least 3 months after tested positive for COVID-19, either through self-test or test in medical settings:
- •(1) Systematic symptoms (fatigue, weakness, general malaise, dizziness);
- •(2) Cardiopulmonary symptoms (breathlessness/dyspnoea, chest pain, cough, excessive sputum, others);
- •(3) Upper respiratory symptoms (voice change, sore throat, nasal congestion, others),
- •(4) Gastrointestinal symptoms (loss of appetite, stomach/abdominal discomfort/pain, weight loss, nausea or vomiting, diarrhoea, others);
- •(5) Musculoskeletal symptoms (muscle pain/myalgia, joint pain/arthralgia, impaired mobility, others);
- •(6) Neurological and neuromuscular symptoms (abnormal reflex status, smell disturbance, taste disturbance, decreased sensation or sensibility, tingling/ paraesthesia, others);
- •(7) Neurocognitive symptoms (memory impairment, concentration impairment, frontal release signs, others), or others (hair loss, skin rash etc.)
- •No regular practice of mindfulness meditation.
排除标准
- •Diagnosed psychiatric disorders, and suicidal ideation, plans, or behaviours, as they may need more intensive clinical care;
- •Recent bereavement or major loss;
- •Cannot understand Chinese as the programs will be conducted in Chinese;
- •Other conditions render them incapable of following the interventions.
研究组 & 干预措施
Intervention group
Control group
结局指标
主要结局
the self-report COVID-19 Yorkshire Rehabilitation Scale (C19-YRS)
时间窗: At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)
次要结局
- depression (measured by the Patient Health Questionnaire-9, PHQ-9)(At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention))
- anxiety (the General Anxiety Disorder-7, GAD-7)(At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention))
- mindfulness level (the 20-item Five Facet Mindfulness Questionnaire, FFMQ)(At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention))
- health service utilization(At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention))
- health related quality of life (the EQ-5D-5L)(At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention))
研究者
研究点 (1)
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