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Recovery-oriented cognitive-behaviour approach for people with schizophrenia in Hong Kong
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注册号：

Registration number：

 ChiCTR1900028695 

最近更新日期：

Date of Last Refreshed on：

 2019-12-31 13:45:21 

注册时间：

Date of Registration：

 2019-12-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Recovery-oriented cognitive-behaviour approach for people with schizophrenia in Hong Kong

Public title：

Recovery-oriented cognitive-behaviour approach for people with schizophrenia in Hong Kong

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effectiveness of a professionally-facilitated recovery-oriented cognitive-behaviour approach for people with schizophrenia in Hong Kong: A comparison to a peer-led peer support programme

Scientific title：

The effectiveness of a professionally-facilitated recovery-oriented cognitive-behaviour approach for people with schizophrenia in Hong Kong: A comparison to a peer-led peer support programme

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：

Professor Daniel Fu Keung Wong 

研究负责人：

Professor Daniel Fu Keung Wong 

Applicant：

Professor Daniel Fu Keung Wong 

Study leader：

Professor Daniel Fu Keung Wong 

申请注册联系人电话：

Applicant telephone：

 +852 39172287

研究负责人电话：

Study leader's
telephone：

+852 39172287

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：

 dfkwong@hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 dfkwong@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：

Pokfulam Road, Hong Kong, China

研究负责人通讯地址：

Pokfulam Road, Hong Kong, China

Applicant address：

Pokfulam Road, Hong Kong, China

Study leader's address：

Pokfulam Road, Hong Kong, China

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：

香港大學

Applicant's institution：

The University of Hong Kong

研究负责人所在单位：

香港大學

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：

 1802026

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：

Human Research Ethics Committee of the University of Hong Kong

Name of the ethic committee：

Human Research Ethics Committee of the University of Hong Kong

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-01-17 00:00:00

伦理委员会联系人：

Human Research Ethics Committee

Contact Name of the ethic committee：

Human Research Ethics Committee

伦理委员会联系地址：

Research Services, the Registry, The University of Hong Kong 9th Floor, Knowles Building Pokfulam, Hong Kong, China

Contact Address of the ethic committee：

Research Services, the Registry, The University of Hong Kong 9th Floor, Knowles Building Pokfulam, Hong Kong, China

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：

香港大學

Primary sponsor：

The University of Hong Kong

研究实施负责（组长）单位地址：

Pokfulam, Hong Kong, China

Primary sponsor's address：

Pokfulam, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

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)：

香港大學

具体地址：

Pokfulam Road, Hong Kong, China

Institution
hospital：

the University of Hong Kong

Address：

Pokfulam Road, Hong Kong, China

经费或物资来源：

General Research Fund (GRF) of the University Grants Committee of the HKSAR

Source(s) of funding：

General Research Fund (GRF) of the University Grants Committee of the HKSAR

研究疾病：

schizophrenia  

Target disease：

schizophrenia

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

This study primarily intends to evaluate the effectiveness and differential benefits of two recovery models, namely, professionally-facilitated recovery-oriented cognitive-behaviour approach (ROCBA) and a peer-led peer support programme (PSP), which have shown initial promising results for Chinese people with schizophrenia in Hong Kong.  

Objectives of Study：

This study primarily intends to evaluate the effectiveness and differential benefits of two recovery models, namely, professionally-facilitated recovery-oriented cognitive-behaviour approach (ROCBA) and a peer-led peer support programme (PSP), which have shown initial promising results for Chinese people with schizophrenia in Hong Kong.

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：

Exclusion criteria include neurological disease or damage that would compromise cognitive functioning, physical handicaps that would interfere with assessment procedures or therapy attendance, and/or suicidal attempts or ideation in the past three months.

Exclusion criteria：

Exclusion criteria include neurological disease or damage that would compromise cognitive functioning, physical handicaps that would interfere with assessment procedures or therapy attendance, and/or suicidal attempts or ideation in the past three months.

研究实施时间：

Study execute time：

从 From 2020-01-01 00:00:00至 To 2020-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-02-01 00:00:00 至 To 2020-06-30 00:00:00

干预措施：

Interventions：

组别：

experimental group 1

样本量：

 50

Group：

experimental group 1

Sample size：

干预措施：

Strength-based cognitive behavioural therapy

干预措施代码：

Intervention：

Strength-based cognitive behavioural therapy

Intervention code：

组别：

experimental group 2

样本量：

 50

Group：

experimental group 2

Sample size：

干预措施：

Peer support programme

干预措施代码：

Intervention：

Peer support programme

Intervention code：

组别：

Control group

样本量：

 50

Group：

Control group

Sample size：

干预措施：

Standard case management

干预措施代码：

Intervention：

Standard case management

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：

Hong Kong

单位(医院)：

 香港大學 

单位级别：

 大學 

Institution
hospital：

the University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

social functioning

指标类型：

主要指标

Outcome：

social functioning

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Mental health recovery

指标类型：

主要指标

Outcome：

Mental health recovery

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Hope

指标类型：

主要指标

Outcome：

Hope

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Quality of life

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Defeatist performance belief

指标类型：

次要指标

Outcome：

Defeatist performance belief

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Asocial belief

指标类型：

次要指标

Outcome：

Asocial belief

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Social support

指标类型：

次要指标

Outcome：

Social support

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：

No

组织：

Sample Name：

No

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 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）：

A research assistant who is blind to the research design will generate the random number sequence for randomization. A series of block sequence following mixed block sizes (the lock size can be three and six) to assign sample numbers equally to each group. And then randomize the possible sequences block

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

A research assistant who is blind to the research design will generate the random number sequence for randomization. A series of block sequence following mixed block sizes (the lock size can be three and six) to assign sample numbers equally to each group. And then randomize the possible sequences block

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：

Open label

Blinding：

Open label

是否共享原始数据：

IPD sharing

是Yes

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）：

We will submit the dataset with metadata information to the HKU repository after the publication of the results and the study. The URL link for the repository is http://hub.hku.hk/

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

We will submit the dataset with metadata information to the HKU repository after the publication of the results and the study. The URL link for the repository is http://hub.hku.hk/

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：

The data is personal survey data approved by HREC. The data is quantitative and will be processed as SPSS system files. Thus the data will mainly be created as .sav data file. The data will also be distributed in several widely used formats, including tab-delimited (for use with Excel), SPSS, HLM, and LISREL. The data will be collected using pencil-and-paper format. Participants went through different intervention arms and completed a battery of standardized questionnaires before the intervention, six months of the intervention, after the intervention and six months after the completion of the intervention. The data will be entered into SPSS files by a research assistant and will be reviewed and double checked by another research assistant to ensure the quality of the data entry. As the data will be consecutively inputted, data file will be saved as a new data file and named using the date when the data file is updated. And the versions of data files will be stored in the laptops of the research assistants and the project manager. The case intake form, case record form and the case summary will be completed by the social workers who provide services to the participants. The data will be uploaded to the HKU repository and the ResMan as required after all the data have been published.

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

The data is personal survey data approved by HREC. The data is quantitative and will be processed as SPSS system files. Thus the data will mainly be created as .sav data file. The data will also be distributed in several widely used formats, including tab-delimited (for use with Excel), SPSS, HLM, and LISREL. The data will be collected using pencil-and-paper format. Participants went through different intervention arms and completed a battery of standardized questionnaires before the intervention, six months of the intervention, after the intervention and six months after the completion of the intervention. The data will be entered into SPSS files by a research assistant and will be reviewed and double checked by another research assistant to ensure the quality of the data entry. As the data will be consecutively inputted, data file will be saved as a new data file and named using the date when the data file is updated. And the versions of data files will be stored in the laptops of the research assistants and the project manager. The case intake form, case record form and the case summary will be completed by the social workers who provide services to the participants. The data will be uploaded to the HKU repository and the ResMan as required after all the data have been published.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-12-31 13:45:21
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