ChiCTR2200061574 版本V1.1 版本创建时间2022/06/29 12:04:08 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：

 ChiCTR2200061574 

最近更新日期：

Date of Last Refreshed on：

 2022-06-29 12:03:19 

注册时间：

Date of Registration：

 2022-06-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Emotion GPS: The Effectiveness of the Stepped-care model in a Mental Health Community Setting in Hong Kong

Public title：

Emotion GPS: The Effectiveness of the Stepped-care model in a Mental Health Community Setting in Hong Kong

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Emotion GPS: The Effectiveness of the Stepped-care model in a Mental Health Community Setting in Hong Kong

Scientific title：

Emotion GPS: The Effectiveness of the Stepped-care model in a Mental Health Community Setting in Hong Kong

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：

LEUNG JUN BEN BENJAMIN 

研究负责人：

PATRICK WING LEUNG LEUNG 

Applicant：

LEUNG JUN BEN BENJAMIN 

Study leader：

PATRICK WING LEUNG LEUNG 

申请注册联系人电话：

Applicant telephone：

 (852) 31882550

研究负责人电话：

Study leader's
telephone：

(852) 39436502

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：

 benjaminleung@nlpra.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 pleung@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：

Rm 601-602, Kimberley House, 35 Kimberley Road, Tsim Sha Tsui, Kowloon.

研究负责人通讯地址：

Rm 356, Sino Building, The Chinese University of Hong Kong, Shatin, New Territories

Applicant address：

Rm 601-602, Kimberley House, 35 Kimberley Road, Tsim Sha Tsui, Kowloon.

Study leader's address：

Rm 356, Sino Building, The Chinese University of Hong Kong, Shatin, New Territories

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：

Emotion GPS

Applicant's institution：

Emotion GPS

研究负责人所在单位：

Affiliation of the Leader：

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：

 2022.055-T

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：

 2022-03-23 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, HK

Contact Address of the ethic committee：

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

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：

研究实施负责（组长）单位：

N/A

Primary sponsor：

N/A

研究实施负责（组长）单位地址：

N/A

Primary sponsor's address：

N/A

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

N/A

省(直辖市)：

N/A

市(区县)：

Country：

N/A

Province：

N/A

City：

单位(医院)：

N/A

具体地址：

N/A

Institution
hospital：

N/A

Address：

N/A

经费或物资来源：

N/A

Source(s) of funding：

N/A

研究疾病：

Common mental disorders  

Target disease：

Common mental disorders

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：

随机抽样 

Study design：

Randomly Sampling 

研究目的：

This study will investigate the effectiveness of LICBT in order to provide insights into the development and application of LICBT for mild to moderate mood disorders. Results of this study will shed light on whether LICBT could improve depression and anxiety symptoms. This study will specifically target individuals with mild to moderate depression or anxiety due to the high prevalence of these disorders in Hong Kong. Individual guided self-help service and high intensity psychoeducational groups such as low intensity cognitive behavioural therapy and psychoeducational group (Unified Protocol group therapy) will be implemented in this study to help us understand the effectiveness of the "stepped-care model" in a mental health setting. The "stepped-care model" is used to reduce the burden of high priority services such as clinical psychologists where waiting times can be long. In our current practice, we adopted the stepped-care model in treating common mental disorders such as depression and anxiety with lower intensity therapies such that patients with milder to moderate symptoms are treated with shorter waiting times, while patients with more severe symptoms are "stepped up" to be treated with more high intensity treatments. Our current study would investigate the process of stepping up clients to higher intensity therapy who show no signs of remission after a course of lower intensity therapy compared with extending the duration of the lower intensity therapy to see the effectiveness of these respective mechanisms. Individuals would first receive a course of lower intensity cognitive behavioural therapy. The depression and anxiety levels, work and social adjustment, and psychological well-being of participants will be assessed at pre-treatment, post-treatment (at the end of the last session). We would then investigate the process of stepping up clients to 1.) higher intensity group therapy or 2.) extended low intensity cognitive behavioral therapy who show no signs of remission after a course of lower intensity therapy. We would again test their depression and anxiety levels along with the other measurements and compare them to see the effectiveness of these respective mechanisms. If LICBT is shown to be effective in treating mild to moderate depression and anxiety under an effective stepped care model, this intervention can be adopted widely in the community and the waiting time for psychological treatments can be minimised. Eventually, the development of LICBT could alleviate the burden of mental health professionals and reduce costs in the healthcare system.  

Objectives of Study：

This study will investigate the effectiveness of LICBT in order to provide insights into the development and application of LICBT for mild to moderate mood disorders. Results of this study will shed light on whether LICBT could improve depression and anxiety symptoms. This study will specifically target individuals with mild to moderate depression or anxiety due to the high prevalence of these disorders in Hong Kong. Individual guided self-help service and high intensity psychoeducational groups such as low intensity cognitive behavioural therapy and psychoeducational group (Unified Protocol group therapy) will be implemented in this study to help us understand the effectiveness of the "stepped-care model" in a mental health setting. The "stepped-care model" is used to reduce the burden of high priority services such as clinical psychologists where waiting times can be long. In our current practice, we adopted the stepped-care model in treating common mental disorders such as depression and anxiety with lower intensity therapies such that patients with milder to moderate symptoms are treated with shorter waiting times, while patients with more severe symptoms are "stepped up" to be treated with more high intensity treatments. Our current study would investigate the process of stepping up clients to higher intensity therapy who show no signs of remission after a course of lower intensity therapy compared with extending the duration of the lower intensity therapy to see the effectiveness of these respective mechanisms. Individuals would first receive a course of lower intensity cognitive behavioural therapy. The depression and anxiety levels, work and social adjustment, and psychological well-being of participants will be assessed at pre-treatment, post-treatment (at the end of the last session). We would then investigate the process of stepping up clients to 1.) higher intensity group therapy or 2.) extended low intensity cognitive behavioral therapy who show no signs of remission after a course of lower intensity therapy. We would again test their depression and anxiety levels along with the other measurements and compare them to see the effectiveness of these respective mechanisms. If LICBT is shown to be effective in treating mild to moderate depression and anxiety under an effective stepped care model, this intervention can be adopted widely in the community and the waiting time for psychological treatments can be minimised. Eventually, the development of LICBT could alleviate the burden of mental health professionals and reduce costs in the healthcare system.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

a) aged 18 years old or above;
b) capable to understand Cantonese;
c) completed a course of around 6 – 8 sessions of LICBT treatment
d) not in remission (phq-9 scores above 10, gad-7 scores above 8)

Inclusion criteria

a) aged 18 years old or above;
b) capable to understand Cantonese;
c) completed a course of around 6 – 8 sessions of LICBT treatment
d) not in remission (phq-9 scores above 10, gad-7 scores above 8)

排除标准：

(1) experiencing active psychotic symptoms; (2) experiencing bipolar symptoms; (3) experiencing
substance abuse; (4) with intellectual disability; (5) experiencing suicidal ideation; and (6) having changes in their medication for
depression or anxiety within past four months.

Exclusion criteria：

(1) experiencing active psychotic symptoms; (2) experiencing bipolar symptoms; (3) experiencing
substance abuse; (4) with intellectual disability; (5) experiencing suicidal ideation; and (6) having changes in their medication for
depression or anxiety within past four months.

研究实施时间：

Study execute time：

从 From 2022-06-15 00:00:00至 To 2023-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-06-15 00:00:00 至 To 2022-10-31 00:00:00

干预措施：

Interventions：

组别：

First group not in remission

样本量：

 45

Group：

First group not in remission

Sample size：

干预措施：

Extended LICBT

干预措施代码：

Intervention：

Extended LICBT

Intervention code：

组别：

Second group not in remission

样本量：

 45

Group：

Second group not in remission

Sample size：

干预措施：

High intensity therapy group

干预措施代码：

Intervention：

High intensity therapy group

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)：

 Hong Kong SAR 

Country：

China

Province：

Hong Kong SAR

City：

Hong Kong SAR

单位(医院)：

 New Life Psychiatric Rehabilitation Association 

单位级别：

 Emotion GPS 

Institution
hospital：

New Life Psychiatric Rehabilitation Association

Level of the institution：

Emotion GPS

测量指标：

Outcomes：

指标中文名：

Depression scores of non-remission participants who are stepped up to high intensity therapy groups will decrease significantly more than non remission participants who receive extended sessions of LICBT

指标类型：

主要指标

Outcome：

Depression scores of non-remission participants who are stepped up to high intensity therapy groups will decrease significantly more than non remission participants who receive extended sessions of LICBT

Type：

Primary indicator

测量时间点：

测量方法：

PHQ-9 questionnaires scores

Measure time point of outcome：

Measure method：

PHQ-9 questionnaires scores

指标中文名：

Anxiety scores of non-remission participants who are stepped up to high intensity therapy groups will decrease significantly more than non remission participants who receive extended sessions of LICBT

指标类型：

主要指标

Outcome：

Anxiety scores of non-remission participants who are stepped up to high intensity therapy groups will decrease significantly more than non remission participants who receive extended sessions of LICBT

Type：

Primary indicator

测量时间点：

测量方法：

GAD-7 questionnaires scores

Measure time point of outcome：

Measure method：

GAD-7 questionnaires scores

指标中文名：

Work and adjustment scale (WSAS) scores of non-remission participants who are stepped up to high intensity groups (UP) will improve significantly more than non remission participants who receive extended sessions of LICBT

指标类型：

次要指标

Outcome：

Work and adjustment scale (WSAS) scores of non-remission participants who are stepped up to high intensity groups (UP) will improve significantly more than non remission participants who receive extended sessions of LICBT

Type：

Secondary indicator

测量时间点：

测量方法：

WSAS questionnaires scores

Measure time point of outcome：

Measure method：

WSAS questionnaires scores

指标中文名：

Quality of life scale (EQ-5D-5L) scores of non-remission participants who are stepped up to high intensity groups (UP) will improve significantly more than non remission participants who receive extended sessions of LICBT

指标类型：

次要指标

Outcome：

Quality of life scale (EQ-5D-5L) scores of non-remission participants who are stepped up to high intensity groups (UP) will improve significantly more than non remission participants who receive extended sessions of LICBT

Type：

Secondary indicator

测量时间点：

测量方法：

EQ-5D-5L questionnaires scores

Measure time point of outcome：

Measure method：

EQ-5D-5L questionnaires scores

采集人体标本：

Collecting sample(s)
from participants：

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 18 岁 years
最大 Max age 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

Research assistant will generate the random number sequences via simple randomization

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

Research assistant will generate the random number sequences via simple randomization

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）：

Calculated Results after
the Study Completed(upload file)：

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：

To protect clients’ privacy, all research data would be handled in line with HA policy in handling/ storage/ destruction of patients’ medical records. Data will be stored electronically in the office computers of New Life Psychiatric Rehabilitation Association. Only relevant research staffs will have access to the data. The data will be kept for seven years after the study finished.

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

To protect clients’ privacy, all research data would be handled in line with HA policy in handling/ storage/ destruction of patients’ medical records. Data will be stored electronically in the office computers of New Life Psychiatric Rehabilitation Association. Only relevant research staffs will have access to the data. The data will be kept for seven years after the study finished.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-06-29 12:03:12