ChiCTR2300068085 版本V1.0 版本创建时间2023/02/06 22:24:34 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：

 ChiCTR2300068085 

最近更新日期：

Date of Last Refreshed on：

 2023-02-06 22:24:18 

注册时间：

Date of Registration：

 2023-02-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A brief mindfulness intervention based on mobile apps to reduce anxiety and stress for Indonesian senior high school teachers: A Pilot Randomized Controlled Trial

Public title：

A brief mindfulness intervention based on mobile apps to reduce anxiety and stress for Indonesian senior high school teachers: A Pilot Randomized Controlled Trial

注册题目简写：

BM-MA

English Acronym：

BM-MA

研究课题的正式科学名称：

A brief mindfulness intervention based on mobile apps to reduce anxiety and stress for Indonesian senior high school teachers: A Pilot Randomized Controlled Trial

Scientific title：

A brief mindfulness intervention based on mobile apps to reduce anxiety and stress for Indonesian senior high school teachers: A Pilot Randomized Controlled Trial

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. Ni Komang Arie Suwastini 

Applicant：

Dr. Nice Maylani Asril 

Study leader：

Dr. Ni Komang Arie Suwastini 

申请注册联系人电话：

Applicant telephone：

 +6282145158155

研究负责人电话：

Study leader's
telephone：

+6281933100024

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：

 arie.suwastini@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/198004042003122001

申请注册联系人通讯地址：

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

研究负责人通讯地址：

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

Applicant address：

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

Study leader's address：

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

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

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 1828/UN.48.16/LT/2022

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：

 2022-09-02 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 Singaraja, Bali, Indonesia 81116

Contact Address of the ethic committee：

Jalan Udayana No.11 Singaraja, 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)：

Bali

市(区县)：

Country：

Indonesia

Province：

Bali

City：

单位(医院)：

Universitas Pendidikan Ganesha

具体地址：

Jalan Udayana,11 Kecamatan Buleleng, Kabupaten Buleleng, Bali, Indonesia 81116

Institution
hospital：

Universitas Pendidikan Ganesha

Address：

Jalan Udayana,11 Kecamatan Buleleng, Kabupaten Buleleng, Bali, Indonesia 81116

经费或物资来源：

Universitas Pendidikan Ganesha, Indonesia

Source(s) of funding：

Universitas Pendidikan Ganesha, Indonesia

研究疾病：

Mental health  

Target disease：

Mental health

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：

The main objective of this pilot study is to evaluate the potential of the brief mindfulness based on mobile apps implementation in real-world settings. The secondary objectives are to determine the effectiveness of the brief-mindfulness intervention based on mobile apps (BM-MA) in reducing participant-reported anxiety symptoms; to evaluate the effectiveness of the BM-MA in reducing participant-reported stress symptoms and improving life satisfaction, self-compassion and sense of self-efficacy; and to evaluate the BM-MA potential for implementation in real-world settings.  

Objectives of Study：

The main objective of this pilot study is to evaluate the potential of the brief mindfulness based on mobile apps implementation in real-world settings. The secondary objectives are to determine the effectiveness of the brief-mindfulness intervention based on mobile apps (BM-MA) in reducing participant-reported anxiety symptoms; to evaluate the effectiveness of the BM-MA in reducing participant-reported stress symptoms and improving life satisfaction, self-compassion and sense of self-efficacy; and to evaluate the BM-MA potential for implementation in real-world settings.

药物成份或治疗方案详述：

This trial will use a repeated-measures, between-group, randomized controlled design. Participants will be informed that they will be randomly assigned either to an experimental group or to a wait-list control group, and will be asked to provide informed consent before completing a brief demographics questionnaire. They will be randomized 1:1 to control and treatment groups. They will then be randomly allocated to the brief mindfulness intervention or to a control group. The control group will be informed that they are a ‘wait-list’ group, and will be required to complete questionnaire measures at baseline, and 7 and 14 days, and 28 days later, before being offered access to the intervention for a further 28 days (should they wish to use it). They will be given detailed instructions on how to download and use the intervention with their smartphone at the end of the wait-list period. The treatment group will be given instructions to complete questionnaire measures at baseline and then again at 7 and 14 days of the intervention. Following baseline measures, the participants in the treatment group will be given an access code and details on how to download the intervention programme to their smartphone. They will be given support to use the app every day during the 14-day study period, and to keep a diary to record hours/days of activity/usage. Between days 6 and 7 of the intervention, participants in both groups will receive an email encouraging them to complete all outcome measures again via Qualtrics. Another email reminder will be sent out within 24 hours of completing the full 14-day intervention (end line assessment) and the follow-up assessment will be held 14 days after end line assessment for both group. If no action is taken further emails will be sent within 5 days of completion. Participants in both groups will be informed that they have the right to withdraw at any point during the study. The primary outcome (anxiety, somatic and social dysfunction) and psychological secondary outcomes (life satisfaction, teacher sense self-efficacy, and self-compassion) will be measured using validated instruments. To evaluate study implementation, analysis will be carried out using repeated measures analysis of variance (ANOVA) with group (mindfulness vs control) and time as factors (baseline, day 7, day 14, day 28). Pearson’s correlation analysis will also be carried out to explore whether potential gains in well-being experienced by the experimental group are related to participants’ subjective ratings of task enjoyment and task difficulty. Post-hoc t-tests will also be carried out to assess mean score differences between the three time points in each group. The feasibility and acceptability assessment for the mobile app also will be done. Data will be analyzed using intention to treat principle and reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline. 

Description for medicine or protocol of treatment in detail：

This trial will use a repeated-measures, between-group, randomized controlled design. Participants will be informed that they will be randomly assigned either to an experimental group or to a wait-list control group, and will be asked to provide informed consent before completing a brief demographics questionnaire. They will be randomized 1:1 to control and treatment groups. They will then be randomly allocated to the brief mindfulness intervention or to a control group. The control group will be informed that they are a ‘wait-list’ group, and will be required to complete questionnaire measures at baseline, and 7 and 14 days, and 28 days later, before being offered access to the intervention for a further 28 days (should they wish to use it). They will be given detailed instructions on how to download and use the intervention with their smartphone at the end of the wait-list period. The treatment group will be given instructions to complete questionnaire measures at baseline and then again at 7 and 14 days of the intervention. Following baseline measures, the participants in the treatment group will be given an access code and details on how to download the intervention programme to their smartphone. They will be given support to use the app every day during the 14-day study period, and to keep a diary to record hours/days of activity/usage. Between days 6 and 7 of the intervention, participants in both groups will receive an email encouraging them to complete all outcome measures again via Qualtrics. Another email reminder will be sent out within 24 hours of completing the full 14-day intervention (end line assessment) and the follow-up assessment will be held 14 days after end line assessment for both group. If no action is taken further emails will be sent within 5 days of completion. Participants in both groups will be informed that they have the right to withdraw at any point during the study. The primary outcome (anxiety, somatic and social dysfunction) and psychological secondary outcomes (life satisfaction, teacher sense self-efficacy, and self-compassion) will be measured using validated instruments. To evaluate study implementation, analysis will be carried out using repeated measures analysis of variance (ANOVA) with group (mindfulness vs control) and time as factors (baseline, day 7, day 14, day 28). Pearson’s correlation analysis will also be carried out to explore whether potential gains in well-being experienced by the experimental group are related to participants’ subjective ratings of task enjoyment and task difficulty. Post-hoc t-tests will also be carried out to assess mean score differences between the three time points in each group. The feasibility and acceptability assessment for the mobile app also will be done. Data will be analyzed using intention to treat principle and reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline. 

纳入标准：

The inclusion criteria for cross sectional study and randomized controlled trial are 1) Indonesian certified senior high school teachers who are able to read and write in Indonesian, 2) adults who are above 18 years of age, 3) have an access to smartphone use, 4) the total GAD-7 score no more than 14 and the total GHQ-12 score no more than 20.

Inclusion criteria

The inclusion criteria for cross sectional study and randomized controlled trial are 1) Indonesian certified senior high school teachers who are able to read and write in Indonesian, 2) adults who are above 18 years of age, 3) have an access to smartphone use, 4) the total GAD-7 score no more than 14 and the total GHQ-12 score no more than 20.

排除标准：

The exclusion criteria for randomized controlled trial are set based on guidelines from MBSR (Santorelli, 2014) and MBCT (Crane et al., 2012), and include 1) engagement with regular practice of mindfulness meditation [e.g for 15-20 mins a day, 2-3 times a week; 2) a history of, presence, or ongoing treatment for a psychological disorder; 3) a positive answer to GHQ-12 questions regarding suicidal, and 4) refusal to fill in the informed consent.

Exclusion criteria：

The exclusion criteria for randomized controlled trial are set based on guidelines from MBSR (Santorelli, 2014) and MBCT (Crane et al., 2012), and include 1) engagement with regular practice of mindfulness meditation [e.g for 15-20 mins a day, 2-3 times a week; 2) a history of, presence, or ongoing treatment for a psychological disorder; 3) a positive answer to GHQ-12 questions regarding suicidal, and 4) refusal to fill in the informed consent.

研究实施时间：

Study execute time：

从 From 2023-02-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-02-01 00:00:00 至 To 2023-03-05 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 289

Group：

Intervention group

Sample size：

干预措施：

Mindfulness-based app

干预措施代码：

Intervention：

Mindfulness-based app

Intervention code：

组别：

Control group

样本量：

 290

Group：

Control group

Sample size：

干预措施：

None

干预措施代码：

Intervention：

None

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)：

  

Country：

Indonesia

Province：

Bali

City：

单位(医院)：

 Universitas Pendidikan Ganesha, Indonesia 

单位级别：

 University 

Institution
hospital：

Universitas Pendidikan Ganesha, Indonesia

Level of the institution：

University

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：

preliminary, baseline, monitoring, endline, follow up

测量方法：

mixed methods

Measure time point of outcome：

preliminary, baseline, monitoring, endline, follow up

Measure method：

mixed methods

指标中文名：

Anxiety

指标类型：

主要指标

Outcome：

Anxiety

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Somatic and social dysfunction

指标类型：

主要指标

Outcome：

Somatic and social dysfunction

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Life satisfaction

指标类型：

次要指标

Outcome：

Life satisfaction

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Teacher sense self-efficacy

指标类型：

次要指标

Outcome：

Teacher sense self-efficacy

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Self-compassion

指标类型：

次要指标

Outcome：

Self-compassion

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

标本中文名：

None

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 60 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 (BM-MA) and control group. 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 treatment (BM-MA) and control group. 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

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 study. To protect participant confidentiality, unique anonymous study IDs will be used for data storing, tracking, and reporting. Multiple imputations will be used to handle missing data as its validity in handling missing data in RCT and is available for most types of data.

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 study. To protect participant confidentiality, unique anonymous study IDs will be used for data storing, tracking, and reporting. Multiple imputations will be used to handle missing data as its validity in handling missing data in RCT and is available for most types of data.

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：

  2023-02-06 22:24:18