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【ChiCTR2500113086】Effectiveness of Digital CBT-I and BT-I combined ACT for Insomnia and Anxiety Symptoms in Youth: A Randomised Control Trial

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基本信息

登记号

ChiCTR2500113086

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

2025-11-24

临床申请受理号

靶点

适应症

Insomnia and anxiety

试验通俗题目

Effectiveness of Digital CBT-I and BT-I combined ACT for Insomnia and Anxiety Symptoms in Youth: A Randomised Control Trial

试验专业题目

Effectiveness of Digital CBT-I and BT-I combined ACT for Insomnia and Anxiety Symptoms in Youth: A Randomised Control Trial

申办单位信息

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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

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临床试验信息

试验目的

1.To compare the effect of dCBT-I, dBT-I-ACT and Health Education in improving anxiety symptoms in youth 2.To compare the effect of dCBT-I, dBT-I-ACT and Health Education in improving insomnia symptoms in youth 3.To compare the effect of dCBT-I, dBT-I-ACT and Health Education in improving depressive symptoms, cognitive flexibility, dysfunctional beliefs about sleep, pre-sleep hyperarousal, and quality of life in youth

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

Stratified randomization will be employed to balance gender and age distribution.

盲法

The data analyst will remain blinded to group allocation to prevent expectation or analysis bias.

试验项目经费来源

None

试验范围

目标入组人数

实际入组人数

第一例入组时间

2025-11-24

试验终止时间

2027-11-30

是否属于一致性

入选标准

i.Chinese youth aged 15-24 years old, ii.Presence of acute insomnia disorder as determined by validated Diagnostic Interview for Sleep Patterns and Disorders (DISP), iii.Presence of anxiety features as defined by General Anxiety Disorder-7 (GAD-7) using cut-off of 15 for detecting moderate anxiety symptoms, iv.Ability to listen, speak, and read Chinese and Cantonese, and v.Written informed consent of participation into the study is given by youth and his/her parent’s if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old vi.Possession of a smartphone；

排除标准

i.A clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability, ii.Having a diagnosed sleep disorder (e.g. delayed sleep phase and narcolepsy) that may potentially contribute to the disruption of sleep quantity and quality as determined by validated Diagnostic Interview for Sleep Patterns and Disorders (DISP), iii.Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by The Structured Clinical Interview (SCID), and iv.Currently receiving psychological treatment and/or pharmacological treatment for insomnia or anxiety disorder.；

研究者信息

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试验机构

The Chinese University of Hong Kong

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研究负责人邮编

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