【ChiCTR2300068935】Brief Cognitive Behavioural Therapy Mobile Apps for Young Adults in Balinese rural area

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基本信息

登记号

ChiCTR2300068935

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

2023-03-01

临床申请受理号

靶点

适应症

Mental health

试验通俗题目

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

试验专业题目

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

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

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.

试验分类

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

盲法

试验项目经费来源

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

试验范围

目标入组人数

194;190

实际入组人数

第一例入组时间

2023-03-01

试验终止时间

2023-12-27

是否属于一致性

入选标准

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.；

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；

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