ChiCTR2000034959 版本V1.0 版本创建时间2020/07/27 04:40:51 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：

 ChiCTR2000034959 

最近更新日期：

Date of Last Refreshed on：

 2020-07-26 00:01:23 

注册时间：

Date of Registration：

 2020-07-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Digital intervention for overseas Filipino workers

Public title：

Digital intervention for overseas Filipino workers

注册题目简写：

English Acronym：

DI-OFW

研究课题的正式科学名称：

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

Scientific title：

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

Dr. Andrian Liem 

研究负责人：

Prof. Brian J Hall 

Applicant：

Dr. Andrian Liem 

Study leader：

Prof. Brian J Hall 

申请注册联系人电话：

Applicant telephone：

 +853 62832518

研究负责人电话：

Study leader's
telephone：

+85362899837

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：

 andrianliem@um.edu.mo

研究负责人电子邮件：

Study leader's E-mail：

 brianhall@nyu.edu

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www.um.edu.mo/fss/psychology/people_1.html

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://www.um-gmh.com/bjh-2/

申请注册联系人通讯地址：

中國澳門特別行政區氹仔大馬路大學

研究负责人通讯地址：

中國上海浦東世紀大道1555

Applicant address：

Avenida da Universidade, Taipa, Macao SAR, China

Study leader's address：

1555 Century Ave, Pudong, Shanghai, 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：

澳門大學

Applicant's institution：

University of Macau

研究负责人所在单位：

紐約大學（上海）& 澳門大學

Affiliation of the Leader：

New York University (Shanghai) & University of Macau

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：

 SSHRE19-APP074-FSS

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：

Research Ethics Committee at the University Macau

Name of the ethic committee：

Research Ethics Committee at the University Macau

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-01-16 00:00:00

伦理委员会联系人：

Drina Wu

Contact Name of the ethic committee：

Drina Wu

伦理委员会联系地址：

中國澳門特別行政區氹仔大馬路大學

Contact Address of the ethic committee：

Avenida da Universidade, Taipa, Macao SAR, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +853 8822 9425

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 drinawu@um.edu.mo

研究实施负责（组长）单位：

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

Primary sponsor：

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

研究实施负责（组长）单位地址：

中國澳門特別行政區氹仔大馬路大學

Primary sponsor's address：

Avenida da Universidade, Taipa, Macao (SAR), China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

澳門特別行政區

市(区县)：

澳門

Country：

China

Province：

Macao SAR

City：

Macao

单位(医院)：

澳門基金會

具体地址：

阿爾梅達里貝羅街

Institution
hospital：

Macao Foundation

Address：

Avenida de Almeida Ribeiro, Macao

经费或物资来源：

澳門大學

Source(s) of funding：

University of Macau

研究疾病：

抑鬱症  

Target disease：

depression

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：

 I期临床试验 

Study phase：

1

研究设计：

随机抽样 

Study design：

Randomly Sampling 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

The digital mental health intervention in this study is a mobile application named Step-by-Step for Filipino users (SbS-F). The original SbS program was developed by experts in the field of psychiatry and global mental health in concert with colleagues at the WHO (Carswell et al., 2018). Behavioral activation (BA) is the primary treatment component in the intervention, which is simple and effective at reducing depressive symptoms (Cuijpers, van Straten, & Warmerdam, 2007; Ekers et al., 2014) and can be delivered digitally with minimum assistance (Ly et al., 2014). Previous trials (e.g., Arjadi et al., 2018; Bolton et al., 2014) demonstrated that BA could be delivered by lay health workers, in person and digitally, to reduce anxiety, depression, and PTSD. Also, BA for PTSD among American veterans was associated with greater reduction in depressive symptoms and higher treatment satisfaction than treatment as usual (Wagner, Jakupcak, Kowalski, Bittinger, & Golshan, 2019). The SbS-F program content is delivered through a series of illustrated sessions that teach users specific skills that can be applied to reduce psychological distress. The sessions articulate into an overall story which is delivered by two main characters, available in female and male versions. They guide the user through the intervention content in an interactive, supportive, and culturally appropriate manner. As informed by our cultural adaptation, the first main character is a wise community elder and the second character is a younger person who applied the Step-by-Step techniques themselves. Each character teaches the user about the program, the intervention techniques and why they work, and model how to apply them through easy to follow real-world examples. The community elder character also teaches the user techniques in greater detail and coaches on how to complete intervention activities. This type of illustrated and adapted format is shown to be an effective digital mental health intervention format (Harper Shehadeh, Heim, Chowdhary, Maercker, & Albanese, 2016). The five therapeutic sessions are: Get started (psychoeducation and trying small and pleasant activities), “Get active” (behavioral activation) “Beat obstacles” (more complex behavioral activation, relaxation), “Get together” (increasing social support) and “Keep it up” (relapse prevention). The intervention will be available online (in mobile application format) with some minimal guidance from trained research assistants called e-helpers. For participants in the intervention group, e-helpers will contact them to explain briefly the SbS-F application. 

Description for medicine or protocol of treatment in detail：

The digital mental health intervention in this study is a mobile application named Step-by-Step for Filipino users (SbS-F). The original SbS program was developed by experts in the field of psychiatry and global mental health in concert with colleagues at the WHO (Carswell et al., 2018). Behavioral activation (BA) is the primary treatment component in the intervention, which is simple and effective at reducing depressive symptoms (Cuijpers, van Straten, & Warmerdam, 2007; Ekers et al., 2014) and can be delivered digitally with minimum assistance (Ly et al., 2014). Previous trials (e.g., Arjadi et al., 2018; Bolton et al., 2014) demonstrated that BA could be delivered by lay health workers, in person and digitally, to reduce anxiety, depression, and PTSD. Also, BA for PTSD among American veterans was associated with greater reduction in depressive symptoms and higher treatment satisfaction than treatment as usual (Wagner, Jakupcak, Kowalski, Bittinger, & Golshan, 2019). The SbS-F program content is delivered through a series of illustrated sessions that teach users specific skills that can be applied to reduce psychological distress. The sessions articulate into an overall story which is delivered by two main characters, available in female and male versions. They guide the user through the intervention content in an interactive, supportive, and culturally appropriate manner. As informed by our cultural adaptation, the first main character is a wise community elder and the second character is a younger person who applied the Step-by-Step techniques themselves. Each character teaches the user about the program, the intervention techniques and why they work, and model how to apply them through easy to follow real-world examples. The community elder character also teaches the user techniques in greater detail and coaches on how to complete intervention activities. This type of illustrated and adapted format is shown to be an effective digital mental health intervention format (Harper Shehadeh, Heim, Chowdhary, Maercker, & Albanese, 2016). The five therapeutic sessions are: Get started (psychoeducation and trying small and pleasant activities), “Get active” (behavioral activation) “Beat obstacles” (more complex behavioral activation, relaxation), “Get together” (increasing social support) and “Keep it up” (relapse prevention). The intervention will be available online (in mobile application format) with some minimal guidance from trained research assistants called e-helpers. For participants in the intervention group, e-helpers will contact them to explain briefly the SbS-F application. 

纳入标准：

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).

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2020-07-25 00:00:00至 To 2021-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-07-25 00:00:00 至 To 2020-10-31 00:00:00

干预措施：

Interventions：

组别：

Control group

样本量：

 53

Group：

Control group

Sample size：

干预措施：

Brief psychoeducation

干预措施代码：

Intervention：

Brief psychoeducation

Intervention code：

组别：

Experimental

样本量：

 53

Group：

Experimental group

Sample size：

干预措施：

Digital intervention

干预措施代码：

Intervention：

Digital intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 澳門特別行政區 

市(区县)：

  

Country：

China

Province：

Macao SAR

City：

单位(医院)：

 澳門大學 

单位级别：

 大學 

Institution
hospital：

University of Macau

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

self-reported depression symptoms

指标类型：

主要指标

Outcome：

self-reported depression symptoms

Type：

Primary indicator

测量时间点：

baseline, endline, follow-up

测量方法：

psychological questionnaire (online)

Measure time point of outcome：

baseline, endline, follow-up

Measure method：

psychological questionnaire (online)

指标中文名：

self-reported anxiety symptoms

指标类型：

次要指标

Outcome：

self-reported anxiety symptoms

Type：

Secondary indicator

测量时间点：

baseline, endline, follow-up

测量方法：

psychological questionnaire (online)

Measure time point of outcome：

baseline, endline, follow-up

Measure method：

psychological questionnaire (online)

指标中文名：

self-reported wellbeing

指标类型：

次要指标

Outcome：

self-reported wellbeing

Type：

Secondary indicator

测量时间点：

baseline, endline, follow-up

测量方法：

psychological questionnaire (online)

Measure time point of outcome：

baseline, endline, follow-up

Measure method：

psychological questionnaire (online)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

No

Sample Name：

Nil

Tissue：

none

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

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 岁 years
最大 Max age 99 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）：

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.

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

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.

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：

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

Blinding：

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

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）：

we will share the findings in scientific journals

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

we will share the findings in scientific journals

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：

All data in the study will be collected electronically and will be held securely on password-protected computers that can be accessed only by the members of the research group. To protect participant confidentiality, unique anonymous study IDs will be used for data storing, tracking, and reporting. The data cleaning process will actively search for errors in a planned way. Multiple imputation will be used to handle missing data as its validity in handling missing data in RCT and is available for most types of data (Jakobsen, Gluud, Wetterslev, & Winkel, 2017).

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

All data in the study will be collected electronically and will be held securely on password-protected computers that can be accessed only by the members of the research group. To protect participant confidentiality, unique anonymous study IDs will be used for data storing, tracking, and reporting. The data cleaning process will actively search for errors in a planned way. Multiple imputation will be used to handle missing data as its validity in handling missing data in RCT and is available for most types of data (Jakobsen, Gluud, Wetterslev, & Winkel, 2017).

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：

  2020-07-26 00:01:23