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【ChiCTR1900020570】Effectiveness of a mental health promotion program to enhance the psychological well-being of elderly in Hong Kong

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基本信息

登记号

ChiCTR1900020570

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2019-01-09

临床申请受理号

靶点

适应症

Elderly mental health

试验通俗题目

Effectiveness of a mental health promotion program to enhance the psychological well-being of elderly in Hong Kong

试验专业题目

Effectiveness of a mental health promotion program to enhance the psychological well-being of elderly in Hong Kong

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

000000

联系人通讯地址

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临床试验信息

试验目的

To devise, implement and evaluate mindfulness and cognitive interventions in the community for the elderly to increase their engagement in promoting mental well-being, and enhance their knowledge and understanding about mental health.

试验分类

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试验类型

随机平行对照

试验分期

卫生服务研究

随机化

A cluster randomised controlled trial will be adopted. The estimated sample size is N=400, with n=200 for mindfulness and n=200 for CSSP, each intervention with n=100 intervention group and n=100 control group. There will be up to 30% over recruitment of subjects taking attrition into consideration. Randomisation&#

盲法

The researchers for data collection are blinded to the group allocation.

试验项目经费来源

Health Care and Promotion Scheme

试验范围

目标入组人数

493

实际入组人数

第一例入组时间

2018-03-14

试验终止时间

2018-12-24

是否属于一致性

入选标准

The inclusion criteria for the mindfulness programme are male or female of 60 years old or above, they are able to comprehend the instructions of the interveners and their physical condition and mobility is suitable to participate in the programme such as lying down, sitting, or walking without walking aids. The inclusion criteria for CSSP are male or female of 60 years old or above, they are able to comprehend the instructions of the interveners.；

排除标准

The exclusion criteria are lifetime history of psychiatric disorders, for example, psychosis, schizophrenia, bipolar affective disorder; substance abuse; alcohol abuse; presence of suicidal risk or ideation; current antipsychotic medication; currently under any counselling or clinically psychological interventions.；

研究者信息

研究负责人姓名

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试验机构

Health Care and Promotion Scheme

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

000000

联系人通讯地址