注册号：

Registration number：

最近更新日期：

Date of Last Refreshed on：

注册时间：

Date of Registration：

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

MoCA量表对创伤后应激障碍患者认知功能损伤的临床研究

Public title：

The clinical study of cognitive impairment in patients with post-traumatic stress disorder by MoCA scale

注册题目简写：

English Acronym：

研究课题的正式科学名称：

精神创伤后应激相关障碍的识别与干预技术研究

Scientific title：

Research on Identification and Intervention Techniques of Posttraumatic Stress Related Disorders

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：

刘超猛

研究负责人：

张桂青

Applicant：

Chaomeng Liu

Study leader：

Guiqing Zhang

申请注册联系人电话：

Applicant telephone：

研究负责人电话：

Study leader's telephone：

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：

研究负责人电子邮件：

Study leader's E-mail：

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：

新疆维吾尔自治区石河子大学医学院中区17号楼

研究负责人通讯地址：

新疆维吾尔自治区石河子大学医学院第一附属医院

Applicant address：

17th Building, Central District of Medical School of Shihezi University, Xinjiang Uygur Autonomous Region, China

Study leader's address：

The First Affiliated Hospital of Medical College, Shihezi University, Xinjiang Uygur Autonomous Region, 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：

新疆维吾尔自治区石河子大学医学院

Applicant's institution：

Medical College, Shihezi University, Xinjiang Uygur Autonomous Region, China

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：

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：

石河子大学医学院第一附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee, First Affiliated Hospital, Medical College, Shihezi University

伦理委员会批准日期：

Date of approved by ethic committee：

伦理委员会联系人：

刘梦明

Contact Name of the ethic committee：

Mengming Liu

伦理委员会联系地址：

新疆石河子大学医学院第一附属医院行政楼

Contact Address of the ethic committee：

The Administrative Building of the First Affiliated Hospital, Shihezi University School of Medicine, Medical College, Shihezi University, Xinjiang Uygur Autonomous Region, 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：

新疆石河子大学医学院

Primary sponsor：

Medical College, Shihezi University, Xinjiang

研究实施负责（组长）单位地址：

新疆石河子大学医学院中区17号楼

Primary sponsor's address：

17th Building, Central District of Medical School of Shihezi University, Xinjiang Uygur Autonomous Region, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

课题资助-精神创伤后应激相关障碍的识别与干预研究

Source(s) of funding：

Research Funding - Identification and Intervention of Post-traumatic Stress-related Disorders

研究疾病：

创伤后应应激障碍

Target disease：

Post-traumatic Stress Disorders

研究疾病代码：

Target disease code：

研究类型：

相关因素研究

Study type：

Relative factors research

研究所处阶段：

Study phase：

Diagnostic New Technique Clincal Study

研究目的：

在《精神障碍诊断与统计手册》（Diagnostic and Statistical Manual of Mental Disorders-four,DSM-4）中，创伤后应激障碍（Post-traumatic Stress Disorder ,PTSD）有三大核心症状，即重体验、麻木回避和高警觉性，在DSM-5中增加了分离感 ，弱化了对情绪情感的关注，对麻木和回避解读更深，更重视在认知领域创伤暴露者心境上的消极改变。以往我们对PTSD患者的记忆功能损害研究较多，如闯入性记忆、创伤性遗忘和自传体记忆，而对其认知功能损伤研究较少，评估工具多以简易精神状态检查表MMSE( Minimum Mental State Examination)为主，Munro C等发现，PTSD患者的记忆损伤与认知障碍并无明显相关，郑莉莎等研究表明，MMSE量表更注重对认知功能损伤中记忆层面的评估，而蒙特利尔量表（Montreal Cognitive Assesssment，MoCA）对认知障碍中执行力的评估效果更好。我们拟运用MoCA量表（北京-广州版）观察创伤事件暴露者的认知功能损伤情况，希望为PTSD临床治疗提供帮助

Objectives of Study：

In the Diagnostic and Statistical Manual of Mental Disorders-four (DSM-4), post-traumatic stress disorder (PTSD) has three core symptoms, namely, re-experience and numbness. Avoidance and high alertness, increased sense of separation in the DSM-5, weakened the concern for emotions and emotions, interpreted numbness and avoidance more deeply, and paid more attention to the negative changes in the mood of traumatic exposed people in the cognitive field. In the past, we have studied a large number of memory impairments in patients with PTSD, such as invasive memory, traumatic amnesia, and autobiographical memory. However, there are few studies on cognitive function impairment, and the assessment tools are mostly MMSE (Minimum Emotion Checklist). (Mental State Examination) mainly, Munro C et al. found that there was no significant correlation between memory impairment and cognitive impairment in PTSD patients. Zheng Lisha et al. showed that the MMSE scale pays more attention to the evaluation of memory in cognitive impairment, while Montreal The table (Montreal Cognitive Assesssment, MoCA) is more effective in assessing executive power in cognitive disorders. We intend to use the MoCA scale (Beijing-Guangzhou version) to observe the cognitive impairment of exposed people with traumatic events and hope to provide assistance for the clinical treatment of PTSD.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

研究设计：

病例对照研究

Study design：

Case-Control study

纳入标准：

选取被石河子大学医学院第一附属医院诊断为PTSD的患者、经历创伤事件未被诊断为PTSD的人群和未经历创伤性事件的健康体检者各28例，签署知情同意书后纳入本次研究（84例全部完成），其中PTSD的诊断依据DSM-5的标准，按照PTSD自评量表（The PTSD Checklist-Civilian Version,PCL-C平时版）评分≧49作为PTSD组和非PTSD组的分界点且均是第一次发病。三组人员在年龄、性别、文化程度（小学至初中为低，高中至大专为中，本科及以上为高）、婚姻状况、民族、月收入（≦2000为低，2000到4000为中，≧4000为高）和医疗支付方式等一般资料具有可比性

Inclusion criteria

A total of 28 patients with PTSD diagnosed in the First Affiliated Hospital of Shihezi University School of Medicine, 28 patients with undiagnosed PTSD who experienced traumatic events, and no physical examination without traumatic events were selected and included in the study after signing informed consent (84). All cases were completed. The diagnosis of PTSD was based on the criteria of DSM-5, and the score of PTSD Checklist-Civilian Version (PCL-C) was 49 as the cut-off point between PTSD group and non-PTSD group. All are the first onset. The three groups were aged, gender, and educational level (low from primary to middle school, high school to college, middle school and above, marriage status, ethnic, monthly income (≦2000 is low, 2000 to 4000 is middle, 4,000 is high) and general information such as medical payment methods are comparable.

排除标准：

⑴有脑外伤、脑占位性病变和严重肝肾功能损伤等重大疾病者； ⑵有精神系统疾病史，如帕金森、癫痫、药物依赖等； ⑶意识不清、不能配合者（如视力、听力障碍和构音障碍等）；

Exclusion criteria：

(1) There are major diseases such as brain trauma, brain occupying lesions, and severe liver and kidney damage; (2) History of psychiatric disorders such as Parkinson's, epilepsy, and drug dependence; (3) Those who are unclear and unable to cooperate (such as visual acuity, hearing impairment and dysarthria);

研究实施时间：

Study execute time：

干预措施：

Interventions：

研究实施地点：

Countries of recruitment and research settings：

测量指标：

Outcomes：

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：

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

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

原始数据公开时间：

The time of sharing IPD：

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）：

2018年12月，丁香园-我的论坛-帖子 http://i.dxy.cn/home#bbs/topic

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

December 2018, Lilac Park - My Forum - Posts

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：

考虑使用ResMan

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

Consider using ResMan

数据管理委员会：

Data Managemen Committee：