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Developing and testing a brief mindfulness just-in-time adaptive intervention for reducing stress of dementia caregivers
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注册号：

Registration number：

 ChiCTR2300071361 

最近更新日期：

Date of Last Refreshed on：

 2025-10-30 10:51:22 

注册时间：

Date of Registration：

 2023-05-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Developing and testing a brief mindfulness just-in-time adaptive intervention for reducing stress of dementia caregivers

Public title：

Developing and testing a brief mindfulness just-in-time adaptive intervention for reducing stress of dementia caregivers

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Developing and testing a brief mindfulness just-in-time adaptive intervention for reducing stress of dementia caregivers

Scientific title：

Developing and testing a brief mindfulness just-in-time adaptive intervention for reducing stress of dementia caregivers

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：

Prof CHOU Kee Lee 

研究负责人：

Prof CHOU Kee Lee 

Applicant：

Prof CHOU Kee Lee 

Study leader：

Prof CHOU Kee Lee 

申请注册联系人电话：

Applicant telephone：

 +852 2948 7473

研究负责人电话：

Study leader's
telephone：

+852 2948 7473

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：

 klchou@eduhk.hk

研究负责人电子邮件：

Study leader's E-mail：

 klchou@eduhk.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 klchou@eduhk.hk

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 klchou@eduhk.hk

申请注册联系人通讯地址：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, Hong Kong

研究负责人通讯地址：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, Hong Kong

Applicant address：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, Hong Kong

Study leader's address：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, 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：

The Education University of Hong Kong

Applicant's institution：

The Education University of Hong Kong

研究负责人所在单位：

The Education University of Hong Kong

Affiliation of the Leader：

The Education 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：

 2021-2022-0276

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 Education University of Hong Kong, Human Research Ethics Committee

Name of the ethic committee：

The Education University of Hong Kong, Human Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-05-05 00:00:00

伦理委员会联系人：

Patsy Chung

Contact Name of the ethic committee：

Patsy Chung

伦理委员会联系地址：

The Education University of Hong Kong c/o Research and Development Office 10 Lo Ping Road, Tai Po, Hong Kong

Contact Address of the ethic committee：

The Education University of Hong Kong c/o Research and Development Office 10 Lo Ping Road, Tai Po, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2948 8120

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hrec@eduhk.hk

研究实施负责（组长）单位：

Research Fund Secretariat, Research Office Health Bureau

Primary sponsor：

Research Fund Secretariat, Research Office Health Bureau

研究实施负责（组长）单位地址：

Research Fund Secretariat Research Office Health Bureau 9/F, Rumsey Street Multi-storey Carpark Building 2 Rumsey Street, Sheung Wan Hong Kong.

Primary sponsor's address：

Research Fund Secretariat Research Office Health Bureau 9/F, Rumsey Street Multi-storey Carpark Building 2 Rumsey Street, Sheung Wan 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)：

The Education University of Hong Kong

具体地址：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, Hong Kong

Institution
hospital：

The Education University of Hong Kong

Address：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, Hong Kong

经费或物资来源：

Health and Medical Research Fund

Source(s) of funding：

Health and Medical Research Fund

研究疾病：

Dementia  

Target disease：

Dementia

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：

1. To determine an effective JITAI decision rule to deliver a brief mindfulness intervention depending on the current state of stress of caregivers Hypotheses: 2. It is more likely that the caregiver will engage in the brief intervention when they are stressed than when they are not. 3. The delivery of a prompt to engage the brief intervention will reduce the likelihood of the caregiver being stressed in the subsequent two hours compared with having no prompt. The effect will be stronger if the prompt is delivered when the caregiver is stressed.  

Objectives of Study：

1. To determine an effective JITAI decision rule to deliver a brief mindfulness intervention depending on the current state of stress of caregivers Hypotheses: 2. It is more likely that the caregiver will engage in the brief intervention when they are stressed than when they are not. 3. The delivery of a prompt to engage the brief intervention will reduce the likelihood of the caregiver being stressed in the subsequent two hours compared with having no prompt. The effect will be stronger if the prompt is delivered when the caregiver is stressed.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. Having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment; 2. Having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers participation or adherence (e.g. acute psychosis).

Exclusion criteria：

1. Having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment; 2. Having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers participation or adherence (e.g. acute psychosis).

研究实施时间：

Study execute time：

从 From 2023-08-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-09-01 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

First Phase

样本量：

 75

Group：

Phase 1 - State of Receptivity

Sample size：

干预措施：

4 days (D1-D4) of psycho-education 16 days (D5-D20) of micro-randomised trial (MRT); 0-6 ecological momentary assessment (EMA) will be sent to participants Participants will be randomized into receiving brief intervention of mindfulness or not.

干预措施代码：

Intervention：

4 days (D1-D4): Psycho-education 16 days (D5-D20): 0 to 6 ecological momentary assessment will be sent to participants; participants will be randomized into receiving mindfulness intervention or not

Intervention code：

组别：

Second Phase - State of Receptivity

样本量：

 120

Group：

Phase 2 - State of Receptivity

Sample size：

干预措施：

4 days (D1-D4) of psycho-education 14 days (D5-D18) static model vs control model 7 days (D12 - D18) adaptive model vs static model

干预措施代码：

Intervention：

4 days (D1-D4): Psycho-education 7 days (D5-D12): Control or Static model 7 days (D13-D20): Static, Adaptive, or Control model

Intervention code：

组别：

Phase 3 - State of Vulnerability

样本量：

 75

Group：

Phase 3 - State of Vulnerability

Sample size：

干预措施：

4 days (D1-D4): Psycho-education; 16 days (D5-D20): 0 to 6 ecological momentary assessment will be sent to participants.

干预措施代码：

Intervention：

4 days (D1-D4): Psycho-education; 16 days (D5-D20): 0 to 6 ecological momentary assessment will be sent to participants.

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)：

 Non-governmental Organisations 

单位级别：

  

Institution
hospital：

Non-governmental Organisations

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

Perceived Stress

指标类型：

主要指标

Outcome：

Perceived Stress

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

14-item Chinese version of the Perceived Stress Scale

指标中文名：

Depressive Symptoms

指标类型：

次要指标

Outcome：

Depressive Symptoms

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

Patient Health Questionnaire 9

指标中文名：

Burden

指标类型：

次要指标

Outcome：

Burden

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

Zarit Burden Interview Scale

指标中文名：

Positive Aspect of Caregiving

指标类型：

次要指标

Outcome：

Positive Aspect of Caregiving

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

Positive Aspect of Caregiving

指标中文名：

Sleep Quality

指标类型：

次要指标

Outcome：

Sleep Quality

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

Pittsburgh Sleep Quality Index

指标中文名：

Quality of Life

指标类型：

次要指标

Outcome：

Quality of Life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

EuroQoL 5-Dimension 5-Level

指标中文名：

Mindfulness

指标类型：

次要指标

Outcome：

Mindfulness

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

Mindful Attention Awareness Scale

指标中文名：

Feasibility and Acceptability of the APP

指标类型：

附加指标

Outcome：

Feasibility and Acceptability of the APP

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Prompt-Specific Questions

指标类型：

附加指标

Outcome：

Prompt-Specific Questions

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Mindfulness Intervention Specific Questions

指标类型：

附加指标

Outcome：

Mindfulness Intervention Specific Questions

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

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：

NA

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

NA

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

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

Participants will be randomly assigned by a research assistant not involved in the study using a random online number generator.

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

Participants will be randomly assigned by a research assistant not involved in the study using a random online number generator.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Research assistant responsible for data collected will be blinded to the intervention assignment.

Blinding：

Research assistant responsible for data collected will be blinded to the intervention assignment.

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）：

De-identify data, protocol, and statistical plans will be shared. Data will be available through emailing to the PI of this project.

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

De-identify data, protocol, and statistical plans will be shared. Data will be available through emailing to the PI of this project.

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：

Participants will be required to provide inform consent before enrolment to the project. All participants will be provided with a unique code number. Separate group of researchers that are not involved in data collection, will input the data collected into the database. The database will be placed online (website to be provided later) when data collection is completed.

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

Participants will be required to provide inform consent before enrolment to the project. All participants will be provided with a unique code number. Separate group of researchers that are not involved in data collection, will input the data collected into the database. The database will be placed online (website to be provided later) when data collection is completed.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-05-12 11:40:32
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