中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500100266
最近更新日期： Date of Last Refreshed on：	2025-04-07 11:16:38
注册时间： Date of Registration：	2025-04-07 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	Just ACT: School-Based Program Using Acceptance and Commitment Therapy (ACT) to Promote Student Well-being
Public title：	Just ACT: School-Based Program Using Acceptance and Commitment Therapy (ACT) to Promote Student Well-being
注册题目简写：
English Acronym：
研究课题的正式科学名称：	Just ACT: School-Based Program Using Acceptance and Commitment Therapy (ACT) to Promote Student Well-being
Scientific title：	Just ACT: School-Based Program Using Acceptance and Commitment Therapy (ACT) to Promote Student Well-being
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：	Amanda Kingsze Cheung	研究负责人：	Amanda Kingsze Cheung
Applicant：	Amanda Kingsze Cheung	Study leader：	Amanda Kingsze Cheung
申请注册联系人电话： Applicant telephone：	+852 3917 5889	研究负责人电话： Study leader's telephone：	+852 3917 5889
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：	aksc@hku.hk	研究负责人电子邮件： Study leader's E-mail：	aksc@hku.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：	Room 666, 6/F, The Jockey Club Tower, Centennial Campus, The University of Hong Kong, Pokfulam Road, Hong Kong	研究负责人通讯地址：	Room 666, 6/F, The Jockey Club Tower, Centennial Campus, The University of Hong Kong, Pokfulam Road, Hong Kong
Applicant address：	Room 666, 6/F, The Jockey Club Tower, Centennial Campus, The University of Hong Kong, Pokfulam Road, Hong Kong	Study leader's address：	Room 666, 6/F, The Jockey Club Tower, Centennial Campus, The University of Hong Kong, Pokfulam Road, 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：	The University of Hong Kong
Applicant's institution：	The University of Hong Kong
研究负责人所在单位：	The University of Hong Kong
Affiliation of the Leader：	The 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：	EA240507	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：	Human Research Ethics Committee, The University of Hong Kong
Name of the ethic committee：	Human Research Ethics Committee, The University of Hong Kong
伦理委员会批准日期： Date of approved by ethic committee：	2024-10-22 00:00:00
伦理委员会联系人：	Eva Poon
Contact Name of the ethic committee：	Eva Poon
伦理委员会联系地址：	9/F Knowles Building, the University of Hong Kong
Contact Address of the ethic committee：	9/F Knowles Building, the University of Hong Kong
伦理委员会联系人电话： Contact phone of the ethic committee：	+852 3917 5267	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

The University of Hong Kong

Primary sponsor：

The University of Hong Kong

研究实施负责（组长）单位地址：

332 Nam Cheong Street, Kowloon, Hong Kong

Primary sponsor's address：

332 Nam Cheong Street, Kowloon, 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 SAR	市(区县)：
Country：	China	Province：	Hong Kong SAR	City：
单位(医院)：	The University of Hong Kong	具体地址：	332 Nam Cheong Street, Kowloon, Hong Kong
Institution hospital：	The University of Hong Kong	Address：	332 Nam Cheong Street, Kowloon, Hong Kong

经费或物资来源：

Lump sum grant received by NLPRA (as part of their routine service)

Source(s) of funding：

Lump sum grant received by NLPRA (as part of their routine service)

研究疾病：

Common mental conditions

Target disease：

Common mental conditions

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：

非随机对照试验

Study design：

Non randomized control

研究目的：

Considering the high level of academic stress among Hong Kong students and the emphasis in the Chinese culture on bringing honor to one’s family (Chyu & Chen, 2022), there is an urgent need for a local prevention program that can help build their psychological capital and strengthen their mental health. The transdiagnostic nature of ACT and its priority on improving well-being to symptom reduction make it a promising approach in school-based programs. Leveraging ACT principles and techniques, this pilot study aims to develop a brief prevention program for local secondary and tertiary school students.

Objectives of Study：

Considering the high level of academic stress among Hong Kong students and the emphasis in the Chinese culture on bringing honor to one’s family (Chyu & Chen, 2022), there is an urgent need for a local prevention program that can help build their psychological capital and strengthen their mental health. The transdiagnostic nature of ACT and its priority on improving well-being to symptom reduction make it a promising approach in school-based programs. Leveraging ACT principles and techniques, this pilot study aims to develop a brief prevention program for local secondary and tertiary school students.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1.Active or current history of psychosis, bipolar disorder, or personality disorder, 2.Active or current report of suicidal attempts, 3.Active or current report of suicidal ideations for more than half the days, 4.Any history of intellectual deficits.

Exclusion criteria：

1.Active or current history of psychosis, bipolar disorder, or personality disorder, 2.Active or current report of suicidal attempts, 3.Active or current report of suicidal ideations for more than half the days, 4.Any history of intellectual deficits.

研究实施时间：

Study execute time：

从 From 2024-10-23 00:00:00至 To 2026-09-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-04-15 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：	Adolescents enrolled in local secondary schools	样本量：	32
Group：	Adolescents enrolled in local secondary schools	Sample size：	32
干预措施：	A four-session group of Acceptance and Commitment Therapy	干预措施代码：
Intervention：	A four-session group of Acceptance and Commitment Therapy	Intervention code：

组别：	Adolescents enrolled in local tertiary schools	样本量：	32
Group：	Adolescents enrolled in local tertiary schools	Sample size：	32
干预措施：	A four-session group of Acceptance and Commitment Therapy	干预措施代码：
Intervention：	A four-session group of Acceptance and Commitment Therapy	Intervention code：

组别：	Adolescents who are out of school	样本量：	32
Group：	Adolescents who are out of school	Sample size：	32
干预措施：	A four-session group of Acceptance and Commitment Therapy	干预措施代码：
Intervention：	A four-session group of Acceptance and Commitment Therapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	China	省(直辖市)：	Hong Kong SAR	市(区县)：
Country：	China	Province：	Hong Kong SAR	City：
单位(医院)：	New Life Psychiatric Rehabilitation Association	单位级别：	Community Mental Health Center
Institution hospital：	New Life Psychiatric Rehabilitation Association	Level of the institution：	Community Mental Health Center

国家：	China	省(直辖市)：	Hong Kong SAR	市(区县)：
Country：	China	Province：	Hong Kong SAR	City：
单位(医院)：	The University of Hong Kong	单位级别：	University
Institution hospital：	The University of Hong Kong	Level of the institution：	University

测量指标：

Outcomes：

指标中文名：	Multidimensional Psychological Flexibility Inventory	指标类型：	主要指标
Outcome：	Multidimensional Psychological Flexibility Inventory	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Flourishing Scale Score	指标类型：	主要指标
Outcome：	Flourishing 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：	Patient Health Questionnaire (9-item) Score	指标类型：	主要指标
Outcome：	Patient Health Questionnaire (9-item) 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：	Generalized Anxiety Disorder (7-item) Score	指标类型：	主要指标
Outcome：	Generalized Anxiety Disorder (7-item) 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：	Cognitive Fusion Questionnaire Score	指标类型：	次要指标
Outcome：	Cognitive Fusion Questionnaire 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：	Child and Adolescent Mindfulness Measure Score	指标类型：	次要指标
Outcome：	Child and Adolescent Mindfulness Measure 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：	Self-as-Context Scale Score	指标类型：	次要指标
Outcome：	Self-as-Context 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：	Engaged Living Scale Score	指标类型：	次要指标
Outcome：	Engaged Living 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：	Demographics	指标类型：	附加指标
Outcome：	Demographics	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Satisfaction with Intervention	指标类型：	附加指标
Outcome：	Satisfaction with Intervention	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Feasibility (attendance and withdrawal/drop-out tracking)	指标类型：	附加指标
Outcome：	Feasibility (attendance and withdrawal/drop-out tracking)	Type：	Additional 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		岁 years
最大 Max age	35	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）：

N/A

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

N/A

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）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	N/A
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	N/A
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：	Data are collected and stored on Qualtrics, a secured online platform to which only authorized research personnel have access. Paperwork from participants who opt for pen-and-paper method are stored in locked cabinets in secured project facilities. Questionnaire data and identifying information are stored separately, linked via a unique code assigned to each participant. Identifying data will be destroyed 5 years after the first publication of study results.
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data are collected and stored on Qualtrics, a secured online platform to which only authorized research personnel have access. Paperwork from participants who opt for pen-and-paper method are stored in locked cabinets in secured project facilities. Questionnaire data and identifying information are stored separately, linked via a unique code assigned to each participant. Identifying data will be destroyed 5 years after the first publication of study results.
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：	2025-04-07 11:16:26