ChiCTR2100050579 版本V1.0 版本创建时间2022/05/01 15:07:10 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：

 ChiCTR2100050579 

最近更新日期：

Date of Last Refreshed on：

 2021-08-29 15:15:50 

注册时间：

Date of Registration：

 2021-08-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Repetitive Negative Thinking of Patients with Common Mental Disorders

Public title：

Repetitive Negative Thinking of Patients with Common Mental Disorders

注册题目简写：

English Acronym：

RNT of Patients with CMD

研究课题的正式科学名称：

Repetitive Negative Thinking of Patients with Common Mental Disorders: The Role of Goal Discrepancy, Rationality, and Psychological Flexibility

Scientific title：

Repetitive Negative Thinking of Patients with Common Mental Disorders: The Role of Goal Discrepancy, Rationality, and Psychological Flexibility

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：

Li Suk Man, Connie 

研究负责人：

Professor CHAN Kin Yuen Calais 

Applicant：

Li Suk Man, Connie 

Study leader：

Professor CHAN Kin Yuen Calais 

申请注册联系人电话：

Applicant telephone：

 +852 93049220

研究负责人电话：

Study leader's
telephone：

+852 2525 8830

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

 +852 2525 0177

申请注册联系人电子邮件：

Applicant E-mail：

 h9611874@connect.hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 calaischan@gmail.com

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：

Department of Clinical Psychology, Room 412, Block B, Staff Quarter, Prince of Wales Hospital, Shatin, Hong Kong

研究负责人通讯地址：

Room 302, Tesbury Centre 28 Queen’s Road East Hong Kong.

Applicant address：

Department of Clinical Psychology, Room 412, Block B, Staff Quarter, Prince of Wales Hospital, Shatin, Hong Kong

Study leader's address：

Room 302, Tesbury Centre 28 Queen’s Road East 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：

香港醫院管理局

Applicant's institution：

Hospital Authority, Hong Kong

研究负责人所在单位：

香港中文大學

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：

 2021.325

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

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：

 2021-08-20 00:00:00

伦理委员会联系人：

Ms. Envy Lee

Contact Name of the ethic committee：

Ms. Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Chee 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：

 +852-35053935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 NA

研究实施负责（组长）单位：

N/A

Primary sponsor：

NA

研究实施负责（组长）单位地址：

N/A

Primary sponsor's address：

NA

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

NA

Source(s) of funding：

NA

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：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

The present study aims at exploring the roles of goal adjustment, irrationality/rationality, and psychological inflexibility/flexibility in the relationship between goal discrepancy and repetitive negative thoughts (RNT) on one hand, as well as the relationship between RNT and psychological distress/well-being on the other hand. By delineating the mechanisms underlying RNT and psychological distress, and examining the relatively importance of each predictors, an integrated model will then provide a preliminary theoretical framework for conceptualizing and tailoring effective ways for reducing RNT and psychological distress among CMD patients in future.  

Objectives of Study：

The present study aims at exploring the roles of goal adjustment, irrationality/rationality, and psychological inflexibility/flexibility in the relationship between goal discrepancy and repetitive negative thoughts (RNT) on one hand, as well as the relationship between RNT and psychological distress/well-being on the other hand. By delineating the mechanisms underlying RNT and psychological distress, and examining the relatively importance of each predictors, an integrated model will then provide a preliminary theoretical framework for conceptualizing and tailoring effective ways for reducing RNT and psychological distress among CMD patients in future.

药物成份或治疗方案详述：

The participants will be invited to complete a psychological battery including a consent form, demographic questionnaire and nine self-reported psychological assessment inventories.  

Description for medicine or protocol of treatment in detail：

The participants will be invited to complete a psychological battery including a consent form, demographic questionnaire and nine self-reported psychological assessment inventories.  

纳入标准：

- Patients are diagnosed having Common Mental Disorders;
- Attends the Li Ka Shing Psychiatric Specialist Clinic of Prince of Wales Hospital (LKSPSC/PWH);
- 18 years of age or older;
- Fluent in Cantonese and/or being literate in Chinese.

Inclusion criteria

- Patients are diagnosed having Common Mental Disorders;
- Attends the Li Ka Shing Psychiatric Specialist Clinic of Prince of Wales Hospital (LKSPSC/PWH);
- 18 years of age or older;
- Fluent in Cantonese and/or being literate in Chinese.

排除标准：

Patients with psychosis, intellectual disabilities, organic brain syndromes, critical medical conditions, and substance-related disorders, indicators of active suicidality or violence.

Exclusion criteria：

Patients with psychosis, intellectual disabilities, organic brain syndromes, critical medical conditions, and substance-related disorders, indicators of active suicidality or violence.

研究实施时间：

Study execute time：

从 From 2021-09-06 00:00:00至 To 2022-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-09-06 00:00:00 至 To 2022-05-01 00:00:00

干预措施：

Interventions：

组别：

patients with Common Mental Disorders

样本量：

 350

Group：

patients with Common Mental Disorders

Sample size：

干预措施：

Self-reported Questionnaires

干预措施代码：

Intervention：

Self-reported Questionnaires

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)：

 威爾士親王醫院 

单位级别：

  

Institution
hospital：

Prince of Wales Hospital, Hospital Authority

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Repetitive Negative Thinking

指标类型：

主要指标

Outcome：

Repetitive Negative Thinking

Type：

Primary indicator

测量时间点：

测量方法：

questionnaires

Measure time point of outcome：

Measure method：

questionnaires

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

组织：

Sample Name：

NA

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 18 岁 years
最大 Max age 80 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）：

NA

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

NA

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：

NA

Blinding：

NA

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)：

NA

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：

NA

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

NA

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：

  2021-08-29 15:15:50