ChiCTR2500113086 版本V1.0 版本创建时间2025/11/24 18:45:50 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：

 ChiCTR2500113086 

最近更新日期：

Date of Last Refreshed on：

 2025-11-24 18:45:44 

注册时间：

Date of Registration：

 2025-11-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia (CBT?I) and BT?I Combined with Acceptance and Commitment Therapy (ACT) for Insomnia and Anxiety Symptoms in Youth: A Randomized Controlled Trial

研究课题代号(代码)：

Study subject ID：

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：

Sun Wai Han 

研究负责人：

Chan Ngan Yin Rachel 

Applicant：

Sun Wai Han 

Study leader：

Chan Ngan Yin Rachel 

申请注册联系人电话：

Applicant telephone：

 +852 3791 0547

研究负责人电话：

Study leader's
telephone：

+852 3791 0548

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：

 julia.sun@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 rachel.chan@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

7/F, Shatin Hospital, 33 A Kung Kok, Ma On Shan, Shatin, New Territories, Hong Kong

研究负责人通讯地址：

7/F, Shatin Hospital, 33 A Kung Kok, Ma On Shan, Shatin, New Territories, Hong Kong

Applicant address：

7/F, Shatin Hospital, 33 A Kung Kok, Ma On Shan, Shatin, New Territories, Hong Kong

Study leader's address：

7/F, Shatin Hospital, 33 A Kung Kok, Ma On Shan, Shatin, New Territories, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Department of Psychiatry, The Chinese University of Hong Kong

Applicant's institution：

Department of Psychiatry, The Chinese University of Hong Kong

研究负责人所在单位：

Department of Psychiatry, The Chinese University of Hong Kong

Affiliation of the Leader：

Department of Psychiatry, The Chinese University of Hong Kong

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：

 2025.272

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：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-10-14 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec@cuhk.edu.hk

研究实施负责（组长）单位：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

Primary sponsor's address：

The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Chinese University of Hong Kong

具体地址：

The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

Institution
hospital：

The Chinese University of Hong Kong

Address：

The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

Insomnia and anxiety  

Target disease：

Insomnia and anxiety

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：

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  

Objectives of Study：

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

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

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

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2025-11-24 00:00:00至 To 2027-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-24 00:00:00 至 To 2026-11-30 00:00:00

干预措施：

Interventions：

组别：

Digital behavioral therapy for insomnia group

样本量：

 72

Group：

Digital behavioral therapy for insomnia group

Sample size：

干预措施：

Treatment content is based on the well-established CBT-I manual with adaptation to the adolescent and youth population. The content of dCBT-I consists of behavioural and cognitive strategies including basic sleep science, circadian and sleep hygiene education, stimulus control, sleep restriction, relaxation techniques, structured worry time, cognitive restructuring, and relapse prevention.

干预措施代码：

Intervention：

Treatment content is based on the well-established CBT-I manual with adaptation to the adolescent and youth population. The content of dCBT-I consists of behavioural and cognitive strategies including basic sleep science, circadian and sleep hygiene education, stimulus control, sleep restriction, relaxation techniques, structured worry time, cognitive restructuring, and relapse prevention.

Intervention code：

组别：

Digital behavioral therapy for insomnia combined with acceptance commitment therapy group

样本量：

 72

Group：

Digital behavioral therapy for insomnia combined with acceptance commitment therapy group

Sample size：

干预措施：

dBT-I-ACT integrated components from acceptance and commitment therapy into the core behavioural strategies for insomnia elements. The additional parts encompass value clarification, mindfulness, and cognitive defusion. Mindfulness meditation audio will be given to the participants for their home practice. Psychoeducation comprises both BT-I and ACT perspective.

干预措施代码：

Intervention：

dBT-I-ACT integrated components from acceptance and commitment therapy into the core behavioural strategies for insomnia elements. The additional parts encompass value clarification, mindfulness, and cognitive defusion. Mindfulness meditation audio will be given to the participants for their home practice. Psychoeducation comprises both BT-I and ACT perspective.

Intervention code：

组别：

Digital health education goup

样本量：

 72

Group：

Digital health education goup

Sample size：

干预措施：

Health Education is served as an active control. It aims at providing an overview on how to achieve health from physiological and psychological perspective. The content ranges from nutrient, functions of different organs, healthy diet, exercise, and sleep.

干预措施代码：

Intervention：

Health Education is served as an active control. It aims at providing an overview on how to achieve health from physiological and psychological perspective. The content ranges from nutrient, functions of different organs, healthy diet, exercise, and sleep.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 The Chinese University of Hong Kong 

单位级别：

 University 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Hamilton Anxiety Rating Scale Score

指标类型：

主要指标

Outcome：

Hamilton Anxiety Rating Scale Score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Hospital Anxiety and Depression Scale Score

指标类型：

主要指标

Outcome：

Hospital Anxiety and Depression Scale Score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

State-trait Anxiety Scale Score

指标类型：

主要指标

Outcome：

State-trait Anxiety Scale Score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Insomnia Severity Index (ISI)

指标类型：

次要指标

Outcome：

Insomnia Severity Index (ISI)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Prospective 7-day Sleep diary

指标类型：

次要指标

Outcome：

Prospective 7-day Sleep diary

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Pediatric Daytime Sleepiness Scale Score

指标类型：

次要指标

Outcome：

Pediatric Daytime Sleepiness Scale Score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Dysfunctional Beliefs and Attitudes about Sleep Scale-16-item (DBAS-16)

指标类型：

次要指标

Outcome：

Dysfunctional Beliefs and Attitudes about Sleep Scale-16-item (DBAS-16)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Acceptance and Action Questionnaire–II (AAQ-II)

指标类型：

次要指标

Outcome：

Acceptance and Action Questionnaire–II (AAQ-II)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Pre-Sleep Arousal Scale Score

指标类型：

次要指标

Outcome：

Pre-Sleep Arousal Scale Score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

White Bear Suppression Inventory (WBSI)

指标类型：

次要指标

Outcome：

White Bear Suppression Inventory (WBSI)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

The Satisfaction With Life Scale Score

指标类型：

次要指标

Outcome：

The Satisfaction With Life Scale Score

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：

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 15 岁 years
最大 Max age 24 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）：

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

Randomization Procedure (please state who generates the random number sequence and by what method)：

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

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

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

Blinding：

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

是否共享原始数据：

IPD sharing

否No

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）：

None

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

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：

EDC

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

EDC

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：

  2025-11-24 18:45:44