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

Registration number：

 ChiCTR2300068084 

最近更新日期：

Date of Last Refreshed on：

 2023-05-13 21:28:36 

注册时间：

Date of Registration：

 2023-02-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Daisy Dexing Zhang 

研究负责人：

Daisy Dexing Zhang 

Applicant：

Daisy Dexing Zhang 

Study leader：

Daisy Dexing Zhang 

申请注册联系人电话：

Applicant telephone：

 +86 852 2252 8462

研究负责人电话：

Study leader's
telephone：

+86 852 2252 8462

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 zhangdxdaisy@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 zhangdxdaisy@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

R406, 4/F, JC School of Public Health and Primary Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., Hong Kong

研究负责人通讯地址：

R406, 4/F, JC School of Public Health and Primary Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., Hong Kong

Applicant address：

R406, 4/F, JC School of Public Health and Primary Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., Hong Kong

Study leader's address：

R406, 4/F, JC School of Public Health and Primary Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

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

Applicant's institution：

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

研究负责人所在单位：

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

Affiliation of the Leader：

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

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 CREC Ref. No. 2022.566

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Co

Name of the ethic committee：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Co

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-12-15 00:00:00

伦理委员会联系人：

Ms Envy Lee

Contact Name of the ethic committee：

Ms Envy Lee

伦理委员会联系地址：

Joint CUHK-NTEC Clinical Research Ethics Committee 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

Contact Address of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

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

Primary sponsor：

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

研究实施负责（组长）单位地址：

Prince of Wales Hospital, Shatin, N.T., Hong Kong

Primary sponsor's address：

Prince of Wales Hospital, Shatin, N.T., Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

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

具体地址：

Prince of Wales Hospital, Shatin, N.T.

Institution
hospital：

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

Address：

Prince of Wales Hospital, Shatin, N.T.

经费或物资来源：

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

Source(s) of funding：

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

研究疾病：

Long COVID-19 symptoms  

Target disease：

Long COVID-19 symptoms

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

This will be an 8-week 1.25-hour weekly online mindfulness practice class, together with self-help audios and a booklet, adapted based on the widely recognized and cited book “Mindfulness: A practical guide to finding peace in a frantic world” written by Mark Williams and Danny Penma. An online briefing session on mindfulness and intervention procedures will be offered prior to the start. Each session will include practices of last session, homework review, new practice, and assignment introduction (except the first and last session). Each class will have about 15 participants. They will be advised and encouraged to integrate mindfulness practices into their daily life and practice at least 20 minutes each day. Mindfulness practice audios (about 3-15 minutes each) will be provided. Besides mindfulness practice audios, a mindfulness self-help booklet will be produced with artwork design and mailed to each participant. The booklet will cover brief introduction of mindfulness, its effects, safety precautions, different mindfulness practices, mindfulness resources, how to establish mindfulness practice habits, and a calendar for mindfulness practices. Furthermore, participants will be asked to report any adverse effects related to mindfulness practices.  

Description for medicine or protocol of treatment in detail：

This will be an 8-week 1.25-hour weekly online mindfulness practice class, together with self-help audios and a booklet, adapted based on the widely recognized and cited book Mindfulness: A practical guide to finding peace in a frantic world written by Mark Williams and Danny Penma. An online briefing session on mindfulness and intervention procedures will be offered prior to the start. Each session will include practices of last session, homework review, new practice, and assignment introduction (except the first and last session). Each class will have about 15 participants. They will be advised and encouraged to integrate mindfulness practices into their daily life and practice at least 20 minutes each day. Mindfulness practice audios (about 3-15 minutes each) will be provided. Besides mindfulness practice audios, a mindfulness self-help booklet will be produced with artwork design and mailed to each participant. The booklet will cover brief introduction of mindfulness, its effects, safety precautions, different mindfulness practices, mindfulness resources, how to establish mindfulness practice habits, and a calendar for mindfulness practices. Furthermore, participants will be asked to report any adverse effects related to mindfulness practices.  

纳入标准：

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2023-02-06 00:00:00至 To 2025-02-05 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-02-06 00:00:00 至 To 2025-02-05 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 165

Group：

Intervention Group

Sample size：

干预措施：

Mindfulness class

干预措施代码：

 I

Intervention：

Mindfulness class

Intervention code：

组别：

Control group

样本量：

 165

Group：

Control group

Sample size：

干预措施：

Health Education

干预措施代码：

 C

Intervention：

Health Education

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

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

单位级别：

 N/A 

Institution
hospital：

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

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

the self-report COVID-19 Yorkshire Rehabilitation Scale (C19-YRS)

指标类型：

主要指标

Outcome：

the self-report COVID-19 Yorkshire Rehabilitation Scale (C19-YRS)

Type：

Primary indicator

测量时间点：

At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)

测量方法：

Questionnaire

Measure time point of outcome：

At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)

Measure method：

Questionnaire

指标中文名：

depression (measured by the Patient Health Questionnaire-9, PHQ-9)

指标类型：

次要指标

Outcome：

depression (measured by the Patient Health Questionnaire-9, PHQ-9)

Type：

Secondary indicator

测量时间点：

At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)

测量方法：

Questionnaire

Measure time point of outcome：

At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)

Measure method：

Questionnaire

指标中文名：

anxiety (the General Anxiety Disorder-7, GAD-7)

指标类型：

次要指标

Outcome：

anxiety (the General Anxiety Disorder-7, GAD-7)

Type：

Secondary indicator

测量时间点：

At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)

测量方法：

Questionnaire

Measure time point of outcome：

At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)

Measure method：

Questionnaire

指标中文名：

mindfulness level (the 20-item Five Facet Mindfulness Questionnaire, FFMQ)

指标类型：

次要指标

Outcome：

mindfulness level (the 20-item Five Facet Mindfulness Questionnaire, FFMQ)

Type：

Secondary indicator

测量时间点：

At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)

测量方法：

Questionnaire

Measure time point of outcome：

At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)

Measure method：

Questionnaire

指标中文名：

health service utilization

指标类型：

次要指标

Outcome：

health service utilization

Type：

Secondary indicator

测量时间点：

At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)

测量方法：

Questionnaire

Measure time point of outcome：

At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)

Measure method：

Questionnaire

指标中文名：

health related quality of life (the EQ-5D-5L)

指标类型：

次要指标

Outcome：

health related quality of life (the EQ-5D-5L)

Type：

Secondary indicator

测量时间点：

At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)

测量方法：

Questionnaire

Measure time point of outcome：

At baseline, 2 months (immediately after intervention) and 5 months (3-month post intervention)

Measure method：

Questionniare

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 100 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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

Randomization Procedure (please state who generates the random number sequence and by what method)：

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

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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.

Blinding：

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.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

NA

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

NA

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Both Case Record Form and Electronic Data Capture

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Both Case Record Form and Electronic Data Capture

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-02-06 19:13:06
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