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Can we prevent insomnia? A randomized controlled trial of brief cognitive-behavioral insomnia prevention program for high-risk adolescents
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注册号:

Registration number:

ChiCTR-IPC-15005966 

最近更新日期:

Date of Last Refreshed on:

2019-03-19 

注册时间:

Date of Registration:

2015-02-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

失眠可以預防嗎? 針對高危青少年預防失眠的隨機對照認知行為計劃 

Public title:

Can we prevent insomnia? A randomized controlled trial of brief cognitive-behavioral insomnia prevention program for high-risk adolescents 

注册题目简写:

Brief CBT-I prevention programme for high risk adolescents 

English Acronym:

Brief CBT-I prevention programme for high risk adolescents 

研究课题的正式科学名称:

失眠可以預防嗎? 針對高危青少年預防失眠的隨機對照認知行為計劃 

Scientific title:

Can we prevent insomnia? A randomized controlled trial of brief cognitive-behavioral insomnia prevention program for high-risk adolescents 

研究课题代号(代码):

Study subject ID:

CRE-2012.576-T 

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:

CUHK_CCT00447 

申请注册联系人:

Mandy Yu 

研究负责人:

Prof. Wing Yun Kwok 

Applicant:

Mandy Yu 

Study leader:

Prof. Wing Yun Kwok 

申请注册联系人电话:

Applicant telephone:

+852 26367593 

研究负责人电话:

Study leader's telephone:

+852 26367748 

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:

mandyyu@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

ykwing@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00447 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00447 

申请注册联系人通讯地址:

Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Shan 

研究负责人通讯地址:

Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Sh 

Applicant address:

Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Shan 

Study leader's address:

Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Sh 

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 Chinese University of Hong Kong 

Applicant's institution:

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:

Nil 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

The Chinese University of Hong Kong 

Name of the ethic committee:

The Chinese University of Hong Kong 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-01-19 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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 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 

Primary sponsor's address:

The Chinese University of Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

Research Grants Council-General Research Fund 

Source(s) of funding:

Research Grants Council-General Research Fund 

研究疾病:

Insomnia 

Target disease:

Insomnia 

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 

研究目的:

針對高危青少年預防失眠的隨機對照認知行為計劃 

Objectives of Study:

A brief cognitive-behavioral insomnia prevention program for high-risk adolescents 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. Chinese aged 12-18 years old; 2. Written informed consent of participation into the study is given by his/her parents or caregivers; 3. Being able to comply with the study protocol; 4. Having at least one of the biological parents (either mother or father) reporting lifetime history or current insomnia disorder as defined by DSM-V (Having >/= 3 times of DIS, DMS, or EMA for 3 months, with significant distress or impairment of daytime functioning; 5. Reporting sub-threshold insomnia symptoms [having sleep difficulty in one of the following domains at least once per month but less than three times per week in the past one month: DIS, DMS, or EMA]. 

Inclusion criteria

1. Chinese aged 12-18 years old; 2. Written informed consent of participation into the study is given by his/her parents or caregivers; 3. Being able to comply with the study protocol; 4. Having at least one of the biological parents (either mother or father) reporting lifetime history or current insomnia disorder as defined by DSM-V (Having >/= 3 times of DIS, DMS, or EMA for 3 months, with significant distress or impairment of daytime functioning; 5. Reporting sub-threshold insomnia symptoms [having sleep difficulty in one of the following domains at least once per month but less than three times per week in the past one month: DIS, DMS, or EMA]. 

排除标准:

1. A current or past history of psychiatric disorder(s) or neurodevelopmental disorder(s); 2. Receiving a medication known to affect sleep continuity and quality (e.g. psychotropics); 3. Having a prominent medical condition known to interfere with sleep continuity and quality(e.g. Eczema, Gastric acid reflux); 4. Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, as ascertained by the Structured Diagnostic Interview for Sleep Patterns and Disorders (DISP). 

Exclusion criteria:

1. A current or past history of psychiatric disorder(s) or neurodevelopmental disorder(s); 2. Receiving a medication known to affect sleep continuity and quality (e.g. psychotropics); 3. Having a prominent medical condition known to interfere with sleep continuity and quality(e.g. Eczema, Gastric acid reflux); 4. Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, as ascertained by the Structured Diagnostic Interview for Sleep Patterns and Disorders (DISP). 

研究实施时间:

Study execute time:

From2015-03-01To  

干预措施:

Interventions:

组别:

Two groups

样本量:

250

Group:

Two groups

Sample size:

干预措施:

Cognitive-behavioral therapy for four weeks versus no active intervention

干预措施代码:

Intervention:

Cognitive-behavioral therapy for four weeks versus no active intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

The Chinese University of Hong Kong 

单位级别:

The Chinese University of Hong Kong 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

The Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

1. Incidence of insomnia disorder as confirmed by a clinical diagnosis of insomnia disorder based on DSM-V criteria

指标类型:

主要指标 

Outcome:

1. Incidence of insomnia disorder as confirmed by a clinical diagnosis of insomnia disorder based on DSM-V criteria

Type:

Primary indicator 

测量时间点:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month, and 18 month after the interventional trial.

测量方法:

Measure time point of outcome:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month, and 18 month after the interventional trial.

Measure method:

指标中文名:

2. The severity of insomnia symptoms as measured by Insomnia Severity Index (ISI) All primary outcomes will be measured at baseline and reassessed at 2-week, 6-month, 12 month, and 18 month after the interventional trial.

指标类型:

主要指标 

Outcome:

2. The severity of insomnia symptoms as measured by Insomnia Severity Index (ISI) All primary outcomes will be measured at baseline and reassessed at 2-week, 6-month, 12 month, and 18 month after the interventional trial.

Type:

Primary indicator 

测量时间点:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month, and 18 month after the interventional trial.

测量方法:

Measure time point of outcome:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month, and 18 month after the interventional trial.

Measure method:

指标中文名:

PDSS (daytime sleepiness scale)

指标类型:

次要指标 

Outcome:

PDSS (daytime sleepiness scale)

Type:

Secondary indicator 

测量时间点:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

测量方法:

Measure time point of outcome:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

Measure method:

指标中文名:

DBAS(sleep belief)

指标类型:

次要指标 

Outcome:

DBAS(sleep belief)

Type:

Secondary indicator 

测量时间点:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

测量方法:

Measure time point of outcome:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

Measure method:

指标中文名:

FIRST(vulnerability to stress-related insomnia)

指标类型:

次要指标 

Outcome:

FIRST(vulnerability to stress-related insomnia)

Type:

Secondary indicator 

测量时间点:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

测量方法:

Measure time point of outcome:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

Measure method:

指标中文名:

ASHS(Adolescent Sleep Hygiene Practice)

指标类型:

次要指标 

Outcome:

ASHS(Adolescent Sleep Hygiene Practice)

Type:

Secondary indicator 

测量时间点:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

测量方法:

Measure time point of outcome:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

Measure method:

指标中文名:

MEQ(Morningness and eveningness questionnaire)

指标类型:

次要指标 

Outcome:

MEQ(Morningness and eveningness questionnaire)

Type:

Secondary indicator 

测量时间点:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

测量方法:

Measure time point of outcome:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

Measure method:

指标中文名:

sleep diary

指标类型:

次要指标 

Outcome:

sleep diary

Type:

Secondary indicator 

测量时间点:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

测量方法:

Measure time point of outcome:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

Measure method:

指标中文名:

actiwatch and salivary cortisol

指标类型:

次要指标 

Outcome:

actiwatch and salivary cortisol

Type:

Secondary indicator 

测量时间点:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

测量方法:

Measure time point of outcome:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

Measure method:

指标中文名:

Mental health and fatigue will be measured by HADS, MFI and Kidscreen-27.

指标类型:

次要指标 

Outcome:

Mental health and fatigue will be measured by HADS, MFI and Kidscreen-27.

Type:

Secondary indicator 

测量时间点:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

测量方法:

Measure time point of outcome:

will be measured at baseline and reassessed at 2-week, 6-month, 12 month and 18 month after the interventional trial.

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 12 years
最大 Max age 18 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):

RCT

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

RCT

盲法:

Single-blind

Blinding:

Single-blind

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-02-11
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