ChiCTR2300068935 版本V1.0 版本创建时间2023/03/01 22:47:48 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：

ChiCTR2300068935 

最近更新日期：

Date of Last Refreshed on：

2023-03-01 22:47:34 

注册时间：

Date of Registration：

2023-03-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Brief Cognitive Behavioural Therapy Mobile Apps for Young Adults in Balinese rural area

Public title：

Brief Cognitive Behavioural Therapy Mobile Apps for Young Adults in Balinese rural area

注册题目简写：

English Acronym：

MB-CBT

研究课题的正式科学名称：

A Development and Implementation of a Brief Cognitive Behavioural Therapy (B-CBT) Based on Mobile Apps (Bali Sujati) in Overcoming Anxiety in Young Adults in Bali Rural Areas: Mixed Methods Study’s Protocol

Scientific title：

A Development and Implementation of a Brief Cognitive Behavioural Therapy (B-CBT) Based on Mobile Apps (Bali Sujati) in Overcoming Anxiety in Young Adults in Bali Rural Areas: Mixed Methods Study’s Protocol

研究课题代号(代码)：

Study subject ID：

 PSYCHOLOGY; COMPUTER SCIENCE

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. Nice Maylani Asril 

研究负责人：

Dr. Nice Maylani Asril 

Applicant：

Dr. Nice Maylani Asril 

Study leader：

Dr. Nice Maylani Asril 

申请注册联系人电话：

Applicant telephone：

+6282145158155

研究负责人电话：

Study leader's telephone：

+6282145158155

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：

nicemaylani.asril@undiksha.ac.id

研究负责人电子邮件：

Study leader's E-mail：

nicemaylani.asril@undiksha.ac.id

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://dosen.undiksha.ac.id/profile/198705082012122001

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

https://dosen.undiksha.ac.id/profile/198705082012122001

申请注册联系人通讯地址：

Jalan Udayana No 11, Kecamatan Buleleng, Kabupaten Buleleng, Bali Indonesia 81116

研究负责人通讯地址：

Jalan Udayana No 11, Kecamatan Buleleng, Kabupaten Buleleng, Bali Indonesia 81116

Applicant address：

Jalan Udayana No 11, Kecamatan Buleleng, Kabupaten Buleleng, Bali Indonesia 81116

Study leader's address：

Jalan Udayana No 11, Kecamatan Buleleng, Kabupaten Buleleng, Bali Indonesia 81116

申请注册联系人邮政编码：

Applicant postcode：

81116

研究负责人邮政编码：

Study leader's postcode：

81116

申请人所在单位：

Universitas Pendidikan Ganesha, Indonesia

Applicant's institution：

Universitas Pendidikan Ganesha, Indonesia

研究负责人所在单位：

Universitas Pendidikan Ganesha, Indonesia

Affiliation of the Leader：

Universitas Pendidikan Ganesha, Indonesia

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

38/UN48.16/LT/2023

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 Universitas Pendidikan Ganesha

Name of the ethic committee：

Research Ethics Committee at the Universitas Pendidikan Ganesha

伦理委员会批准日期：

Date of approved by ethic committee：

2023-02-07 00:00:00

伦理委员会联系人：

Prof. Drs. Sariyasa, M.Sc., Ph.D.

Contact Name of the ethic committee：

Prof. Drs. Sariyasa, M.Sc., Ph.D.

伦理委员会联系地址：

Jalan Udayana No 11, Kecamatan Buleleng, Kabupaten Buleleng, Bali Indonesia 81116

Contact Address of the ethic committee：

Jalan Udayana No 11, Kecamatan Buleleng, Kabupaten Buleleng, Bali Indonesia 81116

伦理委员会联系人电话：

Contact phone of the ethic committee：

+62362 22570

伦理委员会联系人邮箱：

Contact email of the ethic committee：

lppm@undiksha.ac.id

研究实施负责（组长）单位：

Universitas Pendidikan Ganesha, Indonesia

Primary sponsor：

Universitas Pendidikan Ganesha, Indonesia

研究实施负责（组长）单位地址：

Jalan Udayana No 11, Kecamatan Buleleng, Kabupaten Buleleng, Bali Indonesia 81116

Primary sponsor's address：

Jalan Udayana No 11, Kecamatan Buleleng, Kabupaten Buleleng, Bali Indonesia 81116

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Indonesia

省(直辖市)：

DKI Jakarta, Indonesia

市(区县)：

Jakarta

Country：

Indonesia

Province：

DKI Jakarta, Indonesia

City：

Jakarta

单位(医院)：

Direktorat Riset, Teknologi, dan Pengabdian kepada Masyarakat, Kementerian Pendidikan, Kebudayaan, Riset, dan Teknologi, Ministry of Education, Culture, Research and Technologies in Indonesia

具体地址：

Jalan Raya Jenderal Sudirman Pintu I, Gedung D Depdiknas, Senayan Jakarta 10270

Institution
hospital：

Direktorat Riset, Teknologi, dan Pengabdian kepada Masyarakat, Kementerian Pendidikan, Kebudayaan, Riset, dan Teknologi, Ministry of Education, Culture, Research and Technologies in Indonesia

Address：

Jalan Raya Jenderal Sudirman Pintu I, Gedung D Depdiknas, Senayan Jakarta 10270

经费或物资来源：

DIPA Direktorat Riset, Teknologi, dan Pengabdian kepada Masyarakat, Kementerian Pendidikan, Kebudayaan, Riset, dan Teknologi (Ministry of Education, Culture, Research and Technologies in Indonesia) un

Source(s) of funding：

DIPA Direktorat Riset, Teknologi, dan Pengabdian kepada Masyarakat, Kementerian Pendidikan, Kebudayaan, Riset, dan Teknologi (Ministry of Education, Culture, Research and Technologies in Indonesia) un

Target disease：

Mental health

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：

This study aims at finding out the potential of the MB-CBT implementation in real-world settings. In the long term this interventional study aimed to investigate the impact of the MB-CBT, while measuring well-being and perceived social support in young adults in Balinese rural areas. The secondary objectives are to evaluate the effectiveness of the MB-CBT in reducing participant-reported anxiety and stress.  

Objectives of Study：

This study aims at finding out the potential of the MB-CBT implementation in real-world settings. In the long term this interventional study aimed to investigate the impact of the MB-CBT, while measuring well-being and perceived social support in young adults in Balinese rural areas. The secondary objectives are to evaluate the effectiveness of the MB-CBT in reducing participant-reported anxiety and stress.

药物成份或治疗方案详述：

This trial are the 8-session adaptation of the B-CBT programme with the total of 16 days will be delivered to young adults aged 18-30 years with anxiety symptoms. In developing Bali Sujati, we will help user to activate support group features as one of coping strategies techniques in B-CBT considering the characteristics of the Bali rural areas population who strongly hold togetherness values. This study aims at finding out the effectiveness of participating in the Bali Sujati produces significant decreases in the anxiety symptoms and perceived stress. In addition, the aims of this study to investigate the effectiveness of participating in the Bali Sujati produces significant increases in the perceived social support and well being. Data will be analysed with repeated measures analysis of variance using group and time as factors. Post-hoc t-tests will also be carried out to assess mean score differences between the three time points in each group. The intervention participants will be interviewed too examine acceptability and barriers to the intervention. Data will be analyzed using intention to treat principle and reported according the Consolidated Standards of Reporting Trials (CONSORT) guideline. 

Description for medicine or protocol of treatment in detail：

This trial are the 8-session adaptation of the B-CBT programme with the total of 16 days will be delivered to young adults aged 18-30 years with anxiety symptoms. In developing Bali Sujati, we will help user to activate support group features as one of coping strategies techniques in B-CBT considering the characteristics of the Bali rural areas population who strongly hold togetherness values. This study aims at finding out the effectiveness of participating in the Bali Sujati produces significant decreases in the anxiety symptoms and perceived stress. In addition, the aims of this study to investigate the effectiveness of participating in the Bali Sujati produces significant increases in the perceived social support and well being. Data will be analysed with repeated measures analysis of variance using group and time as factors. Post-hoc t-tests will also be carried out to assess mean score differences between the three time points in each group. The intervention participants will be interviewed too examine acceptability and barriers to the intervention. Data will be analyzed using intention to treat principle and reported according the Consolidated Standards of Reporting Trials (CONSORT) guideline. 

纳入标准：

The inclusion criteria are indicate good general health, and no recent adverse life events, have access with smartphone and internet use, and have experienced mild anxiety symptoms as assessed via an initial screening tool with GAD-7 score no more than 14 through survey monkey.

Inclusion criteria

The inclusion criteria are indicate good general health, and no recent adverse life events, have access with smartphone and internet use, and have experienced mild anxiety symptoms as assessed via an initial screening tool with GAD-7 score no more than 14 through survey monkey.

排除标准：

The exclusion criteria for participation in this study are having hard hearing, sight and speech problems, having a serious mental disorder, the GAD-7 score more than 14, and refusing to fill in the informed consent form

Exclusion criteria：

The exclusion criteria for participation in this study are having hard hearing, sight and speech problems, having a serious mental disorder, the GAD-7 score more than 14, and refusing to fill in the informed consent form

研究实施时间：

Study execute time：

从 From 2023-03-01 00:00:00至 To 2023-12-27 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-03-01 00:00:00 至 To 2023-06-08 00:00:00  

干预措施：

Interventions：

组别：

Intervention group

样本量：

194

Group：

Intervention group

Sample size：

干预措施：

Brief CBT based on mobile apps

干预措施代码：

Intervention：

Brief CBT based on mobile apps

Intervention code：

组别：

Control group

样本量：

190

Group：

Control group

Sample size：

干预措施：

Wait for access Bali Sujati programme if they wish to use it after collecting follow up data

干预措施代码：

Intervention：

Wait for access Bali Sujati programme if they wish to use it after collecting follow up data

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Indonesia

省(直辖市)：

 Bali 

市(区县)：

 Singaraja 

Country：

Indonesia 

Province：

Bali 

City：

Singaraja 

单位(医院)：

Universitas Pendidikan Ganesha, Indonesia 

单位级别：

National 

Institution
hospital：

Universitas Pendidikan Ganesha, Indonesia

Level of the institution：

National

测量指标：

Outcomes：

指标中文名：

Feasibility

指标类型：

主要指标

Outcome：

Feasibility

Type：

Primary indicator

测量时间点：

baseline, endline, 2-weeks after treatment, follow-up

测量方法：

mixed methods

Measure time point of outcome：

baseline, endline, 2-weeks after treatment, follow-up

Measure method：

mixed methods

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Psychological assessment

组织：

Sample Name：

Psychological assessment

Tissue：

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 30 岁 years

性别：

男性

Gender：

Male

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 intervention and control groups. The algorithm is designed for permuted block randomization where the total number of participants is set prior to the randomization.

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 intervention and control groups. The algorithm is designed for permuted block randomization where the total number of participants is set prior to the randomization.

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：

Blinding：

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

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.

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.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-03-01 22:47:34