【ChiCTR2300068085】A brief mindfulness intervention based on mobile apps to reduce anxiety and stress for Indonesian senior high school teachers: A Pilot Randomized Controlled Trial

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基本信息

登记号

ChiCTR2300068085

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

2023-02-06

临床申请受理号

靶点

适应症

Mental health

试验通俗题目

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

试验专业题目

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

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

81116

联系人通讯地址

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临床试验信息

试验目的

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.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

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.

盲法

无

试验项目经费来源

Universitas Pendidikan Ganesha, Indonesia

试验范围

目标入组人数

289;290

实际入组人数

第一例入组时间

2023-02-01

试验终止时间

2023-12-31

是否属于一致性

入选标准

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 access to smartphone use; 4. The total GAD-7 score is no more than 14 and the total GHQ-12 score is 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; 4. Refusal to fill in the informed consent.；

研究者信息

研究负责人姓名

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试验机构

Universitas Pendidikan Ganesha, Indonesia

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

81116

联系人通讯地址