【ChiCTR2300068084】Effects of stand-alone mindfulness practices for people with long COVID-19 symptoms: A randomized controlled trial

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基本信息

登记号

ChiCTR2300068084

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2023-02-06

临床申请受理号

靶点

适应症

Long COVID-19 symptoms

试验通俗题目

Effects of stand-alone mindfulness practices for people with long COVID-19 symptoms: A randomized controlled trial

试验专业题目

Effects of stand-alone mindfulness practices for people with long COVID-19 symptoms: A randomized controlled trial

申办单位信息

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临床试验信息

试验目的

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: 1. 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: 2. 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. 3. 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.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Computer-based simple randomization will be applied. The randomization procedure will be conducted by an independent statistician who is experienced in conducting randomization.

盲法

Participants will be asked not to disseminate the intervention contents during the study period to prevent contamination between the intervention and control groups. Due to the nature of the intervention, it is impossible to blind therapists and participants, but the investigators and persons who conduct the statistical analyses will be blinded to treatment allocation.

试验项目经费来源

Health and Medical Research Fund, Food and Health Bureau, HKSAR

试验范围

目标入组人数

165

实际入组人数

第一例入组时间

2023-02-06

试验终止时间

2025-02-05

是否属于一致性

入选标准

Inclusion criteria: 1. Aged 18 years or above, 2. 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.) 3. No regular practice of mindfulness meditation.；

排除标准

Exclusion criteria: 1. Diagnosed psychiatric disorders, and suicidal ideation, plans, or behaviours, as they may need more intensive clinical care; 2. Recent bereavement or major loss; 3. Cannot understand Chinese as the programs will be conducted in Chinese; 4. Other conditions render them incapable of following the interventions.；

研究者信息

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试验机构

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

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