网络心理支持平台对老年神经认知障碍和心理困扰护理人员的有效性研究

注册号:

Registration number:

ChiCTR2600118034 

最近更新日期:

Date of Last Refreshed on:

2026-02-01 13:42:57 

注册时间:

Date of Registration:

2026-02-01 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

网络心理支持平台对老年神经认知障碍和心理困扰护理人员的有效性研究

Public title:

Effectiveness of an Online Psychological Support Platform for Caregivers of elders with neurocognitive disorders and psychological distress

注册题目简写:

English Acronym:

研究课题的正式科学名称:

网络心理支持平台对老年神经认知障碍和心理困扰护理人员的有效性研究

Scientific title:

Effectiveness of an Online Psychological Support Platform for Caregivers of elders with neurocognitive disorders and psychological distress

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:

Harriet Tang 

研究负责人:

Professor Lam Chiu Wa 

Applicant:

Harriet Tang 

Study leader:

Professor Lam Chiu Wa 

申请注册联系人电话:

Applicant telephone:

+852 2831 4305

研究负责人电话:

Study leader's
telephone:

+852 2831 4305

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:

cwwpmex@cuhk.edu.hk

研究负责人电子邮件:

Study leader's E-mail:

cwlam@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:

中国香港特别行政区新界沙田区马料水

研究负责人通讯地址:

中国香港特别行政区新界沙田区马料水

Applicant address:

Ma Liu Shui, Sha Tin District, New Territories, Hong Kong Special Administrative Region, China

Study leader's address:

Ma Liu Shui, Sha Tin District, New Territories, Hong Kong Special Administrative Region, China

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:

香港中文大學

Applicant's institution:

The Chinese University of Hong Kong

研究负责人所在单位:

香港中文大學

Affiliation of the Leader:

The Chinese University of Hong Kong

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

SBRE-25-0495

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:

香港中文大學調查及行為研究操守委員會

Name of the ethic committee:

Survey and Conduct Research Conduct Committee of the University of Chinese Hong Kong

伦理委员会批准日期:

Date of approved by ethic committee:

2025-12-22 00:00:00

伦理委员会联系人:

Ms. Eva Yeung

Contact Name of the ethic committee:

Ms. Eva Yeung

伦理委员会联系地址:

中国香港特别行政区新界沙田区马料水

Contact Address of the ethic committee:

Ma Liu Shui, Sha Tin District, New Territories, Hong Kong Special Administrative Region, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+852 3943 9263

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:

香港中文大學

Primary sponsor:

The Chinese University of Hong Kong

研究实施负责(组长)单位地址:

中国香港特别行政区新界沙田区马料水

Primary sponsor's address:

Ma Liu Shui, Sha Tin District, New Territories, Hong Kong Special Administrative Region, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

香港特别行政区

市(区县):

Country:

China

Province:

Hong Kong Special Administrative Region

City:

单位(医院):

香港中文大學

具体地址:

中国香港特别行政区新界沙田区马料水

Institution
hospital:

The Chinese University of Hong Kong

Address:

Ma Liu Shui, Sha Tin District, New Territories, Hong Kong Special Administrative Region, China

经费或物资来源:

陳廷驛基金會善行舍有限公司

Source(s) of funding:

DHCF Institute of Wellbeing Limited

研究疾病:

精神健康问题和神经认知障碍  

Target disease:

mental health problems and neurocognitive disorders

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:

单臂 

Study design:

Single arm 

研究目的:

The current study aims to develop an online platform with therapeutic stories to facilitate learning of positive aspects of caregiving for caregivers of elders with neurocognitive disorders and psychological distress, and evaluate the effectiveness of an online support platform in mental health outcomes of participants.  

Objectives of Study:

The current study aims to develop an online platform with therapeutic stories to facilitate learning of positive aspects of caregiving for caregivers of elders with neurocognitive disorders and psychological distress, and evaluate the effectiveness of an online support platform in mental health outcomes of participants.

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:

未提及

Exclusion criteria:

Not stated

研究实施时间:

Study execute time:

From 2026-02-01 00:00:00 To 2027-10-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-02-01 00:00:00 To 2027-10-31 00:00:00

干预措施:

Interventions:

组别:

干预组

样本量:

180

Group:

Intervention group

Sample size:

干预措施:

干预将通过一个封闭的Facebook/Instagram群组以短篇故事(文本+音频)的形式发布,每周两次,持续26周(总共52篇帖子)。参与者将被提醒查看帖子,并可以分享匿名的反思/评论。主管将以简短的正念为基础的反思,回答问题,并提供实际的护理指导。

干预措施代码:

Intervention:

The intervention will be delivered through a closed Facebook/Instagram group as short story posts (text + audio), twice a week for 26 weeks (total 52 posts). Participants will be reminded to view the posts and can share anonymous reflections/comments. Supervisors will reply with brief mindfulness-based reflections, answer questions, and provide practical caregiving guidance.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China

Province:

Hong Kong Special Administrative Region

City:

单位(医院):

香港中文大學 

单位级别:

大學 

Institution
hospital:

The Chinese University of Hong Kong

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

常見精神健康徵狀

指标类型:

主要指标

Outcome:

Presence of symptoms of common mental disorders

Type:

Primary indicator

测量时间点:

测量方法:

临床访谈时间表-修订(CIS-R)

Measure time point of outcome:

Measure method:

Clinical Interview Schedule-revised (CIS-R)

指标中文名:

社會和職業功能

指标类型:

主要指标

Outcome:

Social and Occupational Functioning

Type:

Primary indicator

测量时间点:

测量方法:

社会与职业功能评估量表(SOFAS)

Measure time point of outcome:

Measure method:

Social and Occupational Functioning Assessment Scale (SOFAS)

指标中文名:

照顧者負擔

指标类型:

主要指标

Outcome:

Caregiver Burden

Type:

Primary indicator

测量时间点:

测量方法:

护理员负担访谈4项(ZBI)

Measure time point of outcome:

Measure method:

Zarit Caregiver Burden Interview 4-item (ZBI)

指标中文名:

正向照顧經驗

指标类型:

主要指标

Outcome:

Positive Aspects of Caregiving

Type:

Primary indicator

测量时间点:

测量方法:

照顾的积极方面(PAC)量表

Measure time point of outcome:

Measure method:

Positive Aspects of Caregiving (PAC) scale

指标中文名:

照顧者照顧能力

指标类型:

主要指标

Outcome:

Caregiving Competence

Type:

Primary indicator

测量时间点:

测量方法:

中文版照顾能力量表(CCS-C)

Measure time point of outcome:

Measure method:

Chinese Version of the Caregiving Competence Scale (CCS-C)

指标中文名:

身心健康狀況

指标类型:

主要指标

Outcome:

Mental Well-being

Type:

Primary indicator

测量时间点:

测量方法:

沃里克-爱丁堡心理健康量表(WEMWBS)

Measure time point of outcome:

Measure method:

Warwick–Edinburgh Mental Well-being Scale (WEMWBS)

指标中文名:

靜觀覺察注意

指标类型:

主要指标

Outcome:

Mindfulness Attention Awareness

Type:

Primary indicator

测量时间点:

测量方法:

正念注意意识量表(MAAS)

Measure time point of outcome:

Measure method:

Mindfulness Attention Awareness Scale (MAAS)

指标中文名:

生活目標

指标类型:

主要指标

Outcome:

Purpose in Life

Type:

Primary indicator

测量时间点:

测量方法:

人生目标量表(中文版,C-PIL,共4题)

Measure time point of outcome:

Measure method:

Purpose in Life Scale (Chinese version, C-PIL, with 4 questions)

指标中文名:

生活滿意度

指标类型:

主要指标

Outcome:

Satisfaction with Life

Type:

Primary indicator

测量时间点:

测量方法:

人生目标量表(中文版,C-PIL,共4题)

Measure time point of outcome:

Measure method:

Satisfaction with Life Scale (SWLS)

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

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 years
最大 Max age 100 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):

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

None

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

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):

http://www.medresman.org.cn/login.aspx,在试验结束6个月内上传试验数据

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

http://www.medresman.org.cn/login.aspx,Data will be uploaded within 6 months of the end of the trial

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:

电子采集和管理系统

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

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:

 2026-02-01 13:42:52