简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
Mitigating loneliness of older adults through cognitive behavioral approach and peer and family support: A randomized controlled trial
下载XML文档

注册号：

Registration number：

 ChiCTR2400079712 

最近更新日期：

Date of Last Refreshed on：

 2024-01-10 11:28:26 

注册时间：

Date of Registration：

 2024-01-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Mitigating loneliness of older adults through cognitive behavioral approach and peer and family support: A randomized controlled trial

Public title：

Mitigating loneliness of older adults through cognitive behavioral approach and peer and family support: A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Mitigating loneliness of older adults through cognitive behavioral approach and peer and family support: A randomized controlled trial

Scientific title：

Mitigating loneliness of older adults through cognitive behavioral approach and peer and family support: 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：

Phoenix Kit Han Mo 

研究负责人：

Phoenix Kit Han Mo 

Applicant：

Phoenix Kit Han Mo 

Study leader：

Phoenix Kit Han Mo 

申请注册联系人电话：

Applicant telephone：

 +852 2252 8765

研究负责人电话：

Study leader's
telephone：

+852 2252 8765

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：

 phoenix.mo@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 phoenix.mo@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：

202D, The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Hong Kong

研究负责人通讯地址：

202D, The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Hong Kong

Applicant address：

202D, The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Hong Kong

Study leader's address：

202D, The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, 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 Chinese Univesity of Hong Kong

Applicant's institution：

The Chinese Univesity of Hong Kong

研究负责人所在单位：

The Chinese Univesity of Hong Kong

Affiliation of the Leader：

The Chinese Univesity 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：

 SBRE‐22‐0288

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：

Survey and Behavioural Research Ethics

Name of the ethic committee：

Survey and Behavioural Research Ethics

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-12-13 00:00:00

伦理委员会联系人：

Mugi Lau

Contact Name of the ethic committee：

Mugi Lau

伦理委员会联系地址：

Room G05, G/F, Choh-Ming Li Basic Medical Sciences Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Contact Address of the ethic committee：

Room G05, G/F, Choh-Ming Li Basic Medical Sciences Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3943 5233

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 mugilau@cuhk.edu.hk

研究实施负责（组长）单位：

The Chinese Univesity of Hong Kong

Primary sponsor：

The Chinese Univesity of Hong Kong

研究实施负责（组长）单位地址：

The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Hong Kong 9/F, Rumsey Street Multi-storey Carpark Building

Primary sponsor's address：

The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Hong Kong 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 Chinese Univesity of Hong Kong

具体地址：

The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Hong Kong

Institution
hospital：

The Chinese Univesity of Hong Kong

Address：

The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Hong Kong

经费或物资来源：

Health and Medical Research Fund, Food and Health Bureau

Source(s) of funding：

Health and Medical Research Fund, Food and Health Bureau

研究疾病：

Mitigating loneliness  

Target disease：

Mitigating 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：

To evaluate the efficacy of an intervention based on the cognitive behavioral therapy and peer and family support in reducing loneliness, depression, anxiety, and improving social support, life satisfaction, social cognition and quality of life among older adults in Hong Kong  

Objectives of Study：

To evaluate the efficacy of an intervention based on the cognitive behavioral therapy and peer and family support in reducing loneliness, depression, anxiety, and improving social support, life satisfaction, social cognition and quality of life among older adults in Hong Kong

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) currently receiving psychiatric care; and 2) have taken part in any psychological interventions in the past six months.

Exclusion criteria：

1) currently receiving psychiatric care; and 2) have taken part in any psychological interventions in the past six months.

研究实施时间：

Study execute time：

从 From 2023-10-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-03-01 00:00:00 至 To 2024-09-30 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 127

Group：

Intervention group

Sample size：

干预措施：

Participants assigned to the Intervention group will be invited to take part in a 3-month intervention program. The proposed intervention aims to reduce both social and emotional loneliness, by utilizing the four primary intervention techniques that has been proven to be effective in reducing loneliness: increasing opportunities for social interactions, improving social skills and addressing maladaptive cognitions related to loneliness and on quality of social interaction [13]. It includes: 1) CBT sessions; 2) Social activities; 3) Online interactions with family members.

干预措施代码：

Intervention：

Participants assigned to the Intervention group will be invited to take part in a 3-month intervention program. The proposed intervention aims to reduce both social and emotional loneliness, by utilizing the four primary intervention techniques that has been proven to be effective in reducing loneliness: increasing opportunities for social interactions, improving social skills and addressing maladaptive cognitions related to loneliness and on quality of social interaction [13]. It includes: 1) CBT sessions; 2) Social activities; 3) Online interactions with family members.

Intervention code：

组别：

Control group

样本量：

 127

Group：

Control group

Sample size：

干预措施：

Participants in the control group will receive standard care including regular follow-up visits to the GOPC / collaborating NGO. In addition, they will receive the health education materials that will also be received by those in the intervention group bi-weekly through social networking apps.

干预措施代码：

Intervention：

Participants in the control group will receive standard care including regular follow-up visits to the GOPC / collaborating NGO. In addition, they will receive the health education materials that will also be received by those in the intervention group bi-weekly through social networking apps.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 The Chinese University of Hong Kong 

单位级别：

  

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

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：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

测量方法：

6-item De Jong Gierveld Loneliness Scale (DJGLS)

Measure time point of outcome：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

Measure method：

6-item De Jong Gierveld Loneliness Scale (DJGLS)

指标中文名：

Depression

指标类型：

次要指标

Outcome：

Depression

Type：

Secondary indicator

测量时间点：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

测量方法：

15-item Geriatric Depression Scale (GDS)

Measure time point of outcome：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

Measure method：

15-item Geriatric Depression Scale (GDS)

指标中文名：

Anxiety

指标类型：

次要指标

Outcome：

Anxiety

Type：

Secondary indicator

测量时间点：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

测量方法：

7-item General Anxiety Disorder scale (GAD-7)

Measure time point of outcome：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

Measure method：

7-item General Anxiety Disorder scale (GAD-7)

指标中文名：

Social cognition

指标类型：

次要指标

Outcome：

Social cognition

Type：

Secondary indicator

测量时间点：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

测量方法：

Young Schema Questionnaire – Short Form (YSQ-SF)

Measure time point of outcome：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

Measure method：

Young Schema Questionnaire – Short Form (YSQ-SF)

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：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

测量方法：

EuroQOL five-dimension questionnaire (EQ-5D)

Measure time point of outcome：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

Measure method：

EuroQOL five-dimension questionnaire (EQ-5D)

指标中文名：

Satisfaction with life

指标类型：

次要指标

Outcome：

Satisfaction with life

Type：

Secondary indicator

测量时间点：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

测量方法：

5-item Satisfaction with life Scale (SWLS)

Measure time point of outcome：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

Measure method：

5-item Satisfaction with life Scale (SWLS)

指标中文名：

Social support

指标类型：

次要指标

Outcome：

Social support

Type：

Secondary indicator

测量时间点：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

测量方法：

12-item Multidimensional Scale of Perceived Social Support (MSPSS)

Measure time point of outcome：

Baseline (Month 0), post-intervention (Month 3), and 3 months follow up (Month 6)

Measure method：

12-item Multidimensional Scale of Perceived Social Support (MSPSS)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Nil

组织：

Sample Name：

Nil

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 75 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）：

Randomization will be performed by the research assistant who will not be involved in participation recruitment and assessment. Block randomization (size =6) will be used, and participants will be randomly allocated to either intervention or control group, using a computer-generated random numbers table. Allocation will be concealed by serial-numbered opaque sealed envelopes (SNOSE). Such a masking procedure can avoid any bias in completing the baseline questionnaire, and the design follows recommendations of CONSORT Statements to guide randomized controlled studies.

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

Randomization will be performed by the research assistant who will not be involved in participation recruitment and assessment. Block randomization (size =6) will be used, and participants will be randomly allocated to either intervention or control group, using a computer-generated random numbers table. Allocation will be concealed by serial-numbered opaque sealed envelopes (SNOSE). Such a masking procedure can avoid any bias in completing the baseline questionnaire, and the design follows recommendations of CONSORT Statements to guide randomized controlled studies.

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：

None

Blinding：

None

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）：

N/A

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

N/A

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：

Consent will be made before the administration of the survey and intervention. Due to confidentiality, only PI, Co-Is, research assistant and NTEC-CREC can have access to the data. All data collected will be kept strictly confidential and are only accessible by designated adjudication committee, corresponding investigators and research staff. All data will be stored in a confidential database with limited assess. After three years, all data will be destroyed.

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

Consent will be made before the administration of the survey and intervention. Due to confidentiality, only PI, Co-Is, research assistant and NTEC-CREC can have access to the data. All data collected will be kept strictly confidential and are only accessible by designated adjudication committee, corresponding investigators and research staff. All data will be stored in a confidential database with limited assess. After three years, all data will be destroyed.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-01-10 11:28:05
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统