ChiCTR2100045635 版本V1.0 版本创建时间2021/12/06 00:19:32 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100045635 

最近更新日期：

Date of Last Refreshed on：

 2021-04-20 04:02:48 

注册时间：

Date of Registration：

 2021-04-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

正念訓練對改善疲勞性亞健康的中醫心身醫學應用研究

Public title：

The effect of mindfulness training on Fatigue-predominant Subhealth

注册题目简写：

English Acronym：

研究课题的正式科学名称：

正念訓練對改善疲勞性亞健康的中醫心身醫學應用研究

Scientific title：

The effect of mindfulness training on Fatigue-predominant Subhealth

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：

ChiMCTR2100004764

申请注册联系人：

谢乐欣 

研究负责人：

谢乐欣 

Applicant：

Tse Lok Yan 

Study leader：

Tse Lok Yan 

申请注册联系人电话：

Applicant telephone：

 51703825

研究负责人电话：

Study leader's
telephone：

51703825

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：

 17223261@life.hkbu.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 bucm.mrc@gmail.com

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：

香港新界粉嶺華明路20號昌盛苑A座1701室

研究负责人通讯地址：

香港新界粉嶺華明路20號昌盛苑A座1701室

Applicant address：

Flat 1701, Cheong Ching House, Cheong Shing Court, 20 Wah Ming Road, Fanling, Hong Kong

Study leader's address：

Flat 1701, Cheong Ching House, Cheong Shing Court, 20 Wah Ming Road, Fanling, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

 0

研究负责人邮政编码：

Study leader's postcode：

 0

申请人所在单位：

香港浸會大學中醫藥學院

Applicant's institution：

School of Chinese Medicine of Hong Kong Baptist University

研究负责人所在单位：

香港浸會大學中醫藥學院

Affiliation of the Leader：

School of Chinese Medicine of Hong Kong Baptist University

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：

 CMTR-BCM-2020-21_005

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

香港浸會大學倫理研究委員會

Name of the ethic committee：

HKBU Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-02-16 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

香港浸會大學中醫藥學院

Primary sponsor：

School of Chinese Medicine of Hong Kong Baptist University

研究实施负责（组长）单位地址：

香港浸會大學浸會大學道校園賽馬會中醫藥學院大樓

Primary sponsor's address：

Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

香港浸會大學中醫藥學院

具体地址：

香港浸會大學浸會大學道校園賽馬會中醫藥學院大樓

Institution
hospital：

School of Chinese Medicine of Hong Kong Baptist University

Address：

Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon.

经费或物资来源：

香港浸會大學中醫藥學院

Source(s) of funding：

School of Chinese Medicine of Hong Kong Baptist University

研究疾病：

疲勞性亞健康  

Target disease：

Fatigue-predominant Subhealth

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

這項研究主要目的是探討以正念減壓療法為基礎的正念訓練干預對疲勞性亞健康人群的有效性，與對照組相比，觀察干預前後之疲勞水平和生活質量方面的變化，其次為探討情緒與疲勞性亞健康的關係。  

Objectives of Study：

The primary aim of this research is to examine the effectiveness of a mindfulness-based intervention towards the fatigue-predominant subhealth population. It is hypothesized that mindfulness training show effectiveness in the level of fatigue and quality of life compared to the control group. The secondary aim of this research is to examine the relationship between mental state and fatigue-predominant subhealth population.

药物成份或治疗方案详述：

參考MBSR認證導師所撰寫之有關正念訓練的書籍及文獻，考慮可行性後，設計正念訓練四週課程。以下為教學方式舉隅： A. 幻燈片簡報視頻：在干預開始前說明正念是什麼和不是什麼，介紹訓練結構，讓參與者知道未來在團體中大家會如何互動 自行判斷自己是否適合此干預。簡單介紹RAIN 和 STOP技巧。 B. 音頻引導：正念訓練的主要部分需要有聲音帶領進行，由研究者參考由MBSR認證導師過往的音訊或其書中所節錄的講稿親自錄製，剪輯後加上字幕後上載於Youtube私人頻道，給予實驗組連結作正式練習使用：正念呼吸、身體掃描、念頭想法覺察、坐禪、慈心禪。 C. 視頻引導：正念訓練的正念瑜伽或坐襌部分需要有聲音帶領進行，由研究者參考由MBSR認證導師過往的視訊或其書中所節錄的講稿親自錄製，剪輯後加上字幕後上載於Youtube私人頻道，給予實驗組連結作正式練習使用：立式瑜伽。 D. 練習冊：由研究者節選出教學重點的文字版及正念瑜伽圖片版，供個案自行練習時參考。小冊子附有訓練紀錄表以供研究者跟進其完成度，紀錄表將設網上版及可列印版。 

Description for medicine or protocol of treatment in detail：

Participants in the active-treatment group would follow an online mindfulness practice routine that the researcher created based on the standard MBSR course outline. The scripts of recordings or videos in provided materials are excerpted from MBSR guiding books written by certified MBSR instructors. Refer to the books on mindfulness training written by MBSR certified instructors, and after considering the feasibility, the researcher designed a four-week mindfulness training course. The following are details of teaching methods: A. Slide presentation video Before the intervention, a recorded online zoom lecture would be held to explain what concept of mindfulness, to introduce the training structure so as to inform participants how they will interact in groups in the future and judge whether they are suitable for this intervention. A brief introduction to RAIN and STOP techniques in the third week would be performed in this format as well. B. Audio guidance The main part of mindfulness training needs to be guided by voice. The researcher will personally record it by referring to the past audio of the MBSR certified instructor or the excerpted scripts from guide books. After editing, adding subtitles, recoding would be uploaded to the Youtube private channel. The experimental group would be given the links for formal exercises: 15 minutes of mindful breathing, 15 minutes of body scanning, 15 minutes of mindfulness-awareness training, 15 minutes of self-inquiry practice, and 15 minutes of Ci Xin meditation. C. Video guidance The mindfulness yoga or sitting meditation of mindfulness training needs to be guided by video format, other details are the same as audio guidance. This is for 15-minute walking meditation. D. Workbook The text version of the teaching key points, and the picture version of mindfulness yoga are selected by the researcher for reference during self-practice. The booklet consists of training record sheets for researchers to follow up on their completion. The record sheet will be available in an online version and a printable version. E. Sharing sessions through social media groups Sharing thoughts and feelings during mindfulness practices is an important session in the MBSR teaching structure. Due to social distancing measures under the COVID-19 pandemic, the sharing sessions would be changed into texting format (i.e. Dividing experimental groups into smaller groups randomly and creating Whatsapp groups for small group sharing).  

纳入标准：

1. 18-60歲以疲勞為主訴，持續或反復出現三個月或以上人士，經疲勞自評量表FSAS測試後結果於中度及嚴重疲勞範圍；

2. 具有亞健康狀態的臨床表現，包括：
①以疲勞，或睡眠紊亂，或疼痛等軀體症狀表現為主；
②以抑鬱寡歡，或焦躁不安、急躁易怒，或恐懼膽怯，或短期記憶力下降、注意力不能集中等精神心理症狀表現為主；
③以人際交往頻率減低，或人際關係緊張等社會適應能力下降表現為主。
上述 3 條中的任何一條持續發作 3 個月以上，並且自稱已排除可能導致上述表現的疾病者，目前可分别被判斷為處於軀體亞健康、心理亞健康、社會交往亞健康狀態。臨床上，上述三種亞健康表現常常相兼出現。

3.《亞健康評定量表》（SHMS V1.0）中三個子量表任何一個量表分數低於
劃線分數，即生理亞健康分量表＜68 分，心理亞健康分量表＜67 分，同時社會亞健康分量表＜67 分；

4. 能自主行動、心理狀態能夠配合研究。

Inclusion criteria

1) Aged within the range of 18 to 60

2) With continuous or repeated moderate-to-severe fatigue symptoms for three months or more, the result of FSAS is with the range of moderate to severe.

3) Have clinical manifestations of sub-health state, including:
① Mainly manifested by physical symptoms such as fatigue, sleep disturbance, or pain;
② Mainly manifested by mental and psychological symptoms such as depression, restlessness, irritability, or fear and timidity, or short-term memory loss, and inability to concentrate;
③ Mainly manifested by the decline of social adaptability, for instance, a decrease in the frequency of interpersonal communication.

Any one of the above 3 items has been onset for more than 3 months, and those who claim to have ruled out the diseases that may cause the above-mentioned manifestations can be judged as being in physical sub-health, mental sub-health, and social sub-health respectively. Clinically, the above three sub-health manifestations often appear at the same time.

4) The score of any one of the three sub-scales in the "Sub-health Assessment Scale" (SHMS V1.0) is lower than the underlined score, that is, the physiological sub-health subscale <68 points, the mental sub-health subscale <67 points, and the social sub-health subscale <67 points

排除标准：

1. 無法於網上瀏覽影片人士
2. 在過去半年內具正念訓練習慣者
3. 有嚴重精神疾患者
4. 患有嚴重器質性疾病患者
5. 屬急性疲勞者
6. 不具中文讀寫能力

Exclusion criteria：

1) Has practiced mindfulness training in the past 6?months

2) With acute fatigue symptoms (i.e., symptoms last less than 3 months).

3) Cognitively or emotionally impaired

4) Unable to use electronic devices and access to internet (since participants are required to browse teaching videos online)

5) Inability to speak or write

6) Have severe physiological impairment.

研究实施时间：

Study execute time：

从 From 2021-05-01 00:00:00至 To 2022-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-05-01 00:00:00 至 To 2021-09-01 00:00:00

干预措施：

Interventions：

组别：

干預組

样本量：

 20

Group：

Intervention group

Sample size：

干预措施：

正念訓練

干预措施代码：

Intervention：

Mindfulness practice

Intervention code：

组别：

对照组

样本量：

 10

Group：

control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 香港浸會大學中醫藥學院 

单位级别：

 香港浸會大學中醫藥學院 

Institution
hospital：

School of Chinese Medicine of Hong Kong Baptist University

Level of the institution：

School of Chinese Medicine of Hong Kong Baptist University

测量指标：

Outcomes：

指标中文名：

疲勞程度

指标类型：

主要指标

Outcome：

Level of fatigue

Type：

Primary indicator

测量时间点：

干預前， 完成2週的干預後，干預後，干預後4週追蹤

测量方法：

疲勞評定量表

Measure time point of outcome：

baseline, completed 2-week intervention, post-intervention, completed four-week mindfulness intervention, 4-week follow-up, four weeks after post-intervention

Measure method：

Fatigue Assessment Inventory (FAI)

指标中文名：

中醫體質分類

指标类型：

次要指标

Outcome：

Constitution in Chinese Medicine

Type：

Secondary indicator

测量时间点：

干預前， 完成2週的干預後，干預後，干預後4週追蹤

测量方法：

中醫體質分類與判定表

Measure time point of outcome：

baseline, completed 2-week intervention, post-intervention, completed four-week mindfulness intervention, 4-week follow-up, four weeks after post-intervention

Measure method：

Constitution in Chinese Medicine Questionnaire

指标中文名：

生活質量

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

干預前， 完成2週的干預後，干預後，干預後4週追蹤

测量方法：

SF-36

Measure time point of outcome：

baseline, completed 2-week intervention, post-intervention, completed four-week mindfulness intervention, 4-week follow-up, four weeks after post-intervention

Measure method：

SF-36 Health Survey

指标中文名：

感知壓力水平

指标类型：

次要指标

Outcome：

Perceived stress level

Type：

Secondary indicator

测量时间点：

干預前， 完成2週的干預後，干預後，干預後4週追蹤

测量方法：

壓力知覺量表

Measure time point of outcome：

baseline, completed 2-week intervention, post-intervention, completed four-week mindfulness intervention, 4-week follow-up, four weeks after post-intervention

Measure method：

Perceived Stress Scale (PSS)

指标中文名：

抑鬱水平

指标类型：

次要指标

Outcome：

Level of depression

Type：

Secondary indicator

测量时间点：

干預前， 完成2週的干預後，干預後，干預後4週追蹤

测量方法：

抑鬱自評量表

Measure time point of outcome：

baseline, completed 2-week intervention, post-intervention, completed four-week mindfulness intervention, 4-week follow-up, four weeks after post-intervention

Measure method：

Self-rating depression scale (SDS)

指标中文名：

正念水平

指标类型：

次要指标

Outcome：

Level of mindfulness

Type：

Secondary indicator

测量时间点：

干預前， 完成2週的干預後，干預後，干預後4週追蹤

测量方法：

五因素正念量表

Measure time point of outcome：

baseline, completed 2-week intervention, post-intervention, completed four-week mindfulness intervention, 4-week follow-up, four weeks after post-intervention

Measure method：

Five Facet Mindfulness Questionaire

指标中文名：

焦慮水平

指标类型：

次要指标

Outcome：

Level of anxiety

Type：

Secondary indicator

测量时间点：

干預前， 完成2週的干預後，干預後，干預後4週追蹤

测量方法：

焦慮自評量表

Measure time point of outcome：

baseline, completed 2-week intervention, post-intervention, completed four-week mindfulness intervention, 4-week follow-up, four weeks after post-intervention

Measure method：

Self Rating Anxiety Scale, SAS

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

無

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 60 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）：

在研究開始之前，研究負責人謝樂欣會使用線上Research Randomizer（https://www.randomizer.org/）生成平衡的隨機分組。

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

Prior to the start of the study, a balanced randomization list was generated using an online Research Randomizer (https://www.randomizer.org/). The process would be done by Tse Lok Yan (The research coordinator).

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：

Blinding：

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

否No

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）：

將在試驗完成後（1/2022前）把原始數據共享至ResMan临床试验公共管理平台，網址為http://www.medresman.org.cn/login.aspx

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

Upon trial completion (before 1/2022), research would share IPD on ResMan (URL:http://www.medresman.org.cn/login.aspx).

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：

本研究數據收集和管理系统包括纸质或電子的表格記錄案例評估結果及將使用ResMan平台作為电子数据采集和管理系统(Electronic Data Capture, EDC)。

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

This trial would use CRF for data collection and ResMan for the data collection and management system.

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：

  2021-04-20 04:02:48