ChiCTR2300077472 版本V1.3 版本创建时间2024/06/21 16:04:48 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：

 ChiCTR2300077472 

最近更新日期：

Date of Last Refreshed on：

 2024-05-28 17:23:43 

注册时间：

Date of Registration：

 2023-11-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Identification of an Effective Two-stage Adaptive Intervention for Reducing Loneliness among Hong Kong Chinese Older Adults

Public title：

Identification of an Effective Two-stage Adaptive Intervention for Reducing Loneliness among Hong Kong Chinese Older Adults

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Identification of an Effective Two-stage Adaptive Intervention for Reducing Loneliness among Hong Kong Chinese Older Adults

Scientific title：

Identification of an Effective Two-stage Adaptive Intervention for Reducing Loneliness among Hong Kong Chinese Older Adults

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：

 

研究负责人：

 

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)：

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：

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：

 2022-2023-0117

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：

Human Research Ethics Committee of The Education University of Hong Kong

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：

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 8888

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：

Primary sponsor：

The Education University of Hong Kong

研究实施负责（组长）单位地址：

Primary sponsor's address：

10 Lo Ping Road, Tai Po, New Territories, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

具体地址：

Institution
hospital：

The Education University of Hong Kong

Address：

10 Lo Ping Road, Tai Po, New Territories, Hong Kong

经费或物资来源：

Source(s) of funding：

General Research Funding

研究疾病：

 

Target disease：

Loneliness

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：

The overarching objective of this proposed study is to develop and identify an effective two-stage adaptive intervention for optimizing the reduction of loneliness and four secondary outcomes (stress, sleeping problem, symptoms of depression and anxiety) among Hong Kong Chinese older adults using the sequential multiple assignment randomized trial (SMART) approach. The specific objectives of this proposed study are as follows:  

Objectives of Study：

To develop and identify an effective two-stage adaptive intervention for optimizing the reduction of loneliness and four secondary outcomes (stress, sleeping problem, symptoms of depression and anxiety) among Hong Kong Chinese older adults using the sequential multiple assignment randomized trial (SMART) approach. The specific objectives of this proposed study are as follows: 1. To evaluate whether a telephone-delivered behavioral activation (Tele-BA) intervention or a telephone-delivered mindfulness (Tele-MF) intervention is a more effective first-stage intervention in terms of reducing loneliness and four secondary outcomes. 2. To evaluate whether extending the original first-stage intervention with an additional motivation component or switching to an alternative intervention is more effective in reducing loneliness and four secondary outcomes when participants are not responding to the first-stage intervention. 3. To evaluate whether the Tele-BA-Tele-MF sequence (8 weeks) or the Tele-MF- Tele-BA sequence (8 weeks) is more effective in reducing loneliness and four secondary outcomes. 4. To identify which of our four embedded 2-stage adaptive interventions is most effective for reducing loneliness and the four secondary outcomes: (1) 4-week Tele-BA: if no response, deliver another 4 weeks of Tele-BA with an additional motivation component (Tele-BA-and-Tele-BA); otherwise, two monthly booster sessions; (2) 4- week Tele-BA: if no response, deliver a further 4 weeks of Tele-MF (Tele-BA-and- Tele-MF); otherwise, two monthly booster sessions; (3) 4-week Tele-MF: if no response, deliver another 4 weeks of Tele-MF with an additional motivation component (Tele-MF- and-Tele-MF); otherwise, two monthly booster sessions; (4) 4-week Tele-MF: if no response, deliver a further 4 weeks of Tele-BA (Tele-MF-and-Tele-BA); otherwise two monthly booster sessions.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1) Hong Kong Chinese older adults, aged 65 and older; 2) Able to communicate through Cantonese over the phone; 3) Have no cognitive impairment; 4) Have no psychiatric disorder, learning disability, or active suicidal ideation; 5) Not engaged in any psychotherapy, psychosocial intervention, regular systematic mindfulness meditation, or related mind-body practice in the past six months; 6) Feeling lonely (cut-off <6 of 3-item UCLA Loneliness Scale)

Inclusion criteria

1. Hong Kong Chinese older adults, aged >= 65 years; 2. Able to communicate through Cantonese over the phone; 3. Have no cognitive impairment; 4. Have no psychiatric disorder, learning disability, or active suicidal ideation; 5. Not engaged in any psychotherapy, psychosocial intervention, regular systematic mindfulness meditation, or related mind-body practice in the past six months; 6. Feeling lonely (cut-off < 6 of 3-item UCLA Loneliness Scale).

排除标准：

Those for do not meet the inclusion criteria.

Exclusion criteria：

Those for do not meet the inclusion criteria.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-05-15 00:00:00 至 To 2024-11-30 00:00:00

干预措施：

Interventions：

组别：

Tele-BA (Responders)

样本量：

 61

Group：

Tele-BA (Responders)

Sample size：

干预措施：

4 weeks with 8 biweekly intervention session focusing on behavioural activation. Afterwhich, participants will receive 2 biweekly booster session.

干预措施代码：

Intervention：

4 weeks with 8 biweekly intervention session focusing on behavioural activation. Afterwhich, participants will receive 2 biweekly booster session.

Intervention code：

组别：

Tele-MF (Responders)

样本量：

 61

Group：

Tele-MF (Responders)

Sample size：

干预措施：

4 weeks with 8 biweekly intervention session focusing on mindfulness. Afterwhich, participants will receive 2 biweekly booster session.

干预措施代码：

Intervention：

4 weeks with 8 biweekly intervention session focusing on mindfulness. Afterwhich, participants will receive 2 biweekly booster session.

Intervention code：

组别：

Tele-BA (Non-responders)

样本量：

 61

Group：

Tele-BA (Non-responders)

Sample size：

干预措施：

Will only receive a 4 weeks behavioural activation intervention.

干预措施代码：

Intervention：

Will only receive a 4 weeks behavioural activation intervention.

Intervention code：

组别：

Tele-MF (Non-responders)

样本量：

 61

Group：

Tele-MF (Non-responders)

Sample size：

干预措施：

Will only receive a 4 weeks mindfulness intervention.

干预措施代码：

Intervention：

Will only receive a 4 weeks mindfulness intervention.

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)：

 Community 

单位级别：

 Community 

Institution
hospital：

Community

Level of the institution：

Community

测量指标：

Outcomes：

指标中文名：

Loneliness

指标类型：

主要指标

Outcome：

Loneliness

Type：

Primary indicator

测量时间点：

测量方法：

20-item Revised-UCLA

Measure time point of outcome：

Measure method：

20-item Revised-UCLA

指标中文名：

Stress

指标类型：

次要指标

Outcome：

Stress

Type：

Secondary indicator

测量时间点：

测量方法：

10-item Perceived Stress Scale

Measure time point of outcome：

Measure method：

10-item Perceived Stress Scale

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：

19-item Pittsburgh Sleep Quality Index

Measure time point of outcome：

Measure method：

19-item Pittsburgh Sleep Quality Index

指标中文名：

Depression

指标类型：

次要指标

Outcome：

Depression

Type：

Secondary indicator

测量时间点：

测量方法：

9-item Patient Health Questionnaire

Measure time point of outcome：

Measure method：

9-item Patient Health Questionnaire

指标中文名：

Anxiety

指标类型：

次要指标

Outcome：

Anxiety

Type：

Secondary indicator

测量时间点：

测量方法：

7-item Generalised Anxiety Disorder scale

Measure time point of outcome：

Measure method：

7-item Generalised Anxiety Disorder scale

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：

20-item Five Facet Mindfulness Questionnaire; FFMQ-SF

Measure time point of outcome：

Measure method：

20-item Five Facet Mindfulness Questionnaire; FFMQ-SF

指标中文名：

Health

指标类型：

附加指标

Outcome：

Health

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Positive and meaning activities

指标类型：

次要指标

Outcome：

Positive and meaning activities

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Engagement of activities

指标类型：

次要指标

Outcome：

Engagement of activities

Type：

Secondary indicator

测量时间点：

测量方法：

10-item Social Engagement and Activities Questionnaire

Measure time point of outcome：

Measure method：

10-item Social Engagement and Activities Questionnaire

指标中文名：

Loneliness

指标类型：

次要指标

Outcome：

Loneliness

Type：

Secondary indicator

测量时间点：

测量方法：

6-items De Jong Gierveld

Measure time point of outcome：

Measure method：

6-items De Jong Gierveld

指标中文名：

Age

指标类型：

附加指标

Outcome：

Age

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Gender

指标类型：

附加指标

Outcome：

Gender

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Marital Status

指标类型：

附加指标

Outcome：

Marital Status

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Living arrangements

指标类型：

附加指标

Outcome：

Living arrangements

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Education attainment

指标类型：

附加指标

Outcome：

Education attainment

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Employment status

指标类型：

附加指标

Outcome：

Employment status

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Household income

指标类型：

附加指标

Outcome：

Household income

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Financial Status

指标类型：

附加指标

Outcome：

Financial Status

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Use of social and healthcare services

指标类型：

附加指标

Outcome：

Use of social and healthcare services

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：

NA

组织：

NA

Sample Name：

NA

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 65 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）：

After participants have taken a quiz to test their understanding that their participation is voluntary, they will be randomized into one of four groups stratified by gender (female, male), age (65-74; 75-84; 85+) and baseline loneliness score to ensure equal representation between intervention groups.

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

After participants have taken a quiz to test their understanding that their participation is voluntary, they will be randomized into one of four groups stratified by gender (female, male), age (65-74; 75-84; 85+) and baseline loneliness score to ensure equal representation between intervention groups.

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：

NA

Blinding：

NA

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）：

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：

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

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-11-09 16:24:02