洞察市场格局
解锁药品研发情报

客服电话

400-9696-311

医药数据查询

【ChiCTR2000034959】Digital intervention for overseas Filipino workers

查看原文

立即下载

基本信息

登记号

ChiCTR2000034959

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2020-07-26

临床申请受理号

靶点

适应症

抑鬱症

试验通俗题目

Digital intervention for overseas Filipino workers

试验专业题目

A digital mental health intervention to reduce depressive symptoms among overseas Filipino workers: Hybrid type 1 effectiveness-implementation randomized controlled trial

申办单位信息

申请人联系人

请登录查看

申请人名称

请登录查看

联系人邮箱

请登录查看

联系人邮编

联系人通讯地址

请登录查看

临床试验信息

试验目的

The main objective of this study is to determine the effectiveness of the Filipino version of the WHO Step-by-Step (SbS-F) program to decrease participant-reported depressive symptoms compared to enhanced care as usual (ECAU); and the secondary objectives are to evaluate the effectiveness of the SbS-F to decrease participant-reported anxiety symptoms and improve wellbeing; and evaluate the SbS-Fs potential for implementation in real-world settings.

试验分类

请登录查看

试验类型

随机抽样

试验分期

Ⅰ期

随机化

Participants will be randomized by the built-in algorithm in the mobile app with 1:1 ratio to the treatment (SbS-F) and control (ECAU) arms. The algorithm is designed for permuted block randomization where the total number of participants is set prior to the randomization. The algorithm will also randomly.

盲法

Due to the characteristics and design of this study, blinding of treatment assignment and outcome assessments will not be feasible.

试验项目经费来源

澳門大學

试验范围

目标入组人数

实际入组人数

第一例入组时间

2020-07-25

试验终止时间

2021-07-31

是否属于一致性

入选标准

Male or female overseas Filipino workers (OFWs) will be included if they meet the following criteria: 1) aged 18 or over; 2) understand English and/or Tagalog; 3) holds a valid working visa in Macao; 4) will stay in Macao for at least six months more; 5) have a mobile phone; 6) have internet access; 7) score 10 on the Patient Health Questionnaire (PHQ-9).；

排除标准

OFWs will be excluded from the study if they: 1) have suicidal intent (more than half the days or nearly every day of the previous two weeks) based on item 9 on the PHQ-9; 2) currently or in the last three months received psychological treatment.；

研究者信息

研究负责人姓名

请登录查看

试验机构

Research Services and Knowledge Transfer Office (RSKTO), University of Macau

研究负责人电话

请登录查看

研究负责人邮箱

请登录查看

研究负责人邮编

联系人通讯地址

请登录查看