今天是:2019-07-21 星期日

职业康复治疗对精神分裂症残疾患者康复的作用
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注册号:

Registration number:

ChiCTR1900024103 

最近更新日期:

Date of Last Refreshed on:

2019-07-01 

注册时间:

Date of Registration:

2019-06-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

职业康复治疗对精神分裂症残疾患者康复的作用 

Public title:

The effect of occupational rehabilitation therapy on the rehabilitation of disabled patients with schizophenia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

职业康复治疗对精神分裂症残疾患者康复的作用 

Scientific title:

The effect of occupational rehabilitation therapy on the rehabilitation of disabled patients with schizophenia 

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:

姚淑敏 

研究负责人:

闫芳 

Applicant:

Shumin Yao 

Study leader:

Fang Yan 

申请注册联系人电话:

Applicant telephone:

+86 13269583301 

研究负责人电话:

Study leader's telephone:

+86 13488788273 

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:

bread82@163.com 

研究负责人电子邮件:

Study leader's E-mail:

emillyyf@163.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:

北京市西城区德胜门外安康胡同5号 

研究负责人通讯地址:

北京市西城区德胜门外安康胡同5号 

Applicant address:

5 Ankang Hutong, Deshengmen Wai, Xicheng District, Beijing, China 

Study leader's address:

5 Ankang Hutong, Deshengmen Wai, Xicheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100088 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

首都医科大学附属北京安定医院 

Applicant's institution:

Beijing Anding Hospital Affiliated to Capital Medical University 

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:

(2018)科研第(45)号 

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:

首都医科大学附属北京安定医院伦理委员会 

Name of the ethic committee:

Ethics committee of Beijing anding hospital affiliated to capital medical university 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-06-25 

伦理委员会联系人:

贾津晶 

Contact Name of the ethic committee:

Jinjing Jia 

伦理委员会联系地址:

北京市西城区德胜门外安康胡同5号 

Contact Address of the ethic committee:

5 Ankang Hutong, Deshengmen Wai, Xicheng District, Beijing, 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:

首都医科大学附属北京安定医院 

Primary sponsor:

Beijing Anding Hospital Affiliated to Capital Medical University 

研究实施负责(组长)单位地址:

北京市西城区德胜门外安康胡同5号 

Primary sponsor's address:

5 Ankang Hutong, Deshengmen Wai, Xicheng District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京安定医院

具体地址:

北京市西城区德胜门外安康胡同5号

Institution
hospital:

Beijing Anding Hospital Affiliated to Capital Medical University

Address:

5 Ankang Hutong, Deshengmen Wai, Xicheng District, Beijing, China

经费或物资来源:

首都临床特色应用研究与成果推广 

Source(s) of funding:

Application research and promotion of clinical characteristics in capital 

研究疾病:

精神分裂症 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

编制《精神分裂症职业康复技能训练程式》,包括操作流程、内容、标准和实施规范,培训精神专科医院门诊和基层精防队伍中康复治疗人员掌握本项技术,探讨以该程式为主要技术的职业康复治疗对减轻或消除精神分裂症所致精神残疾的作用,提高患者的社会功能和生活质量,促进其融入社会。 

Objectives of Study:

1. To compile the "Vocational Rehabilitation Skills Training Program for schizophrenia", including the treatment process, contents, standards and implementation norms and train the mental health workers in the community and psychiatric hospitals to master this techniques; 2. To explore the role of occupational rehabilitation therapy in alleviating or eliminating mental disability caused by schizophrenia, and to improve the social functioning of patients.  

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) 符合美国精神障碍分类与诊断统计手册第五版中精神分裂症诊断标准; (2) 18 岁≤年龄≤55 岁; (3) 初中及以上文化水平,居住地在北京市城区及近郊区; (4) 病情处于非急性期:阳性和阴性症状量表评分( positive and negative symptoms scale, PANSS) 评分≤50 分; (5) SDSS 评分达到轻度精神残疾及以上; (6) 康复者和/或康复者家属、监护人或法律代表签署知情同意书。  

Inclusion criteria

1. meet the diagnostic criteria of schizophrenia in the fifth edition of the American manual of classification and diagnostic statistics of mental disorders; 2. aged 18 to 55 years old; 3. junior high school education or above, living in urban area and suburbs of Beijing; 4. in the non-acute stage: positive and negative symptoms scale (PANSS) score <=50; 5. SDSS score of mild mental disability or above. 

排除标准:

(1) 伴器质性精神障碍,痴呆,盲、聋哑或严重肢体残疾者; (2) 共患其它精神疾病:如精神发育迟滞; (3) 精神活性物质依赖者; (4) 合并有严重的心、脑、肝、肺、肾或造血系统等躯体疾病者。  

Exclusion criteria:

1. Persons with organic mental disorders, dementia, blindness, deafness, or severe physical disability; 2. suffering from other mental diseases: such as mental retardation; 3. psychoactive substance dependence; 4. patients with severe physical diseases such as heart, brain, liver, lung, kidney or hematopoietic system. 

研究实施时间:

Study execute time:

From2019-07-01To 2020-07-01 

干预措施:

Interventions:

组别:

干预组

样本量:

80

Group:

Experimental group

Sample size:

干预措施:

常规康复训练+职业康复技能训练

干预措施代码:

Intervention:

Vocational Rehabilitation Skills Training

Intervention code:

组别:

对照组

样本量:

80

Group:

control group

Sample size:

干预措施:

常规康复训练

干预措施代码:

Intervention:

routine occupational therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京安定医院 

单位级别:

三级甲等医院 

Institution
hospital:

Beijing Anding Hospital Affiliated to Capital Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市朝阳区第三医院 

单位级别:

二级医院 

Institution
hospital:

Beijing chaoyang district third hospital  

Level of the institution:

Second A Hospital 

测量指标:

Outcomes:

指标中文名:

阳性和阴性症状量表

指标类型:

主要指标 

Outcome:

Positive and Negative Syndrome Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

社会功能缺陷筛选量表

指标类型:

主要指标 

Outcome:

Social Disability Screening Schedule

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

世界卫生组织生活质量量表简表

指标类型:

主要指标 

Outcome:

WHOQOL-BREF

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基本认知能力测验

指标类型:

次要指标 

Outcome:

primary cognitive abilites test

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:

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 55 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):

由专人(不参与评估与治疗)进行区组随机化分组的方法产生随机序列

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

specially-assigned person(who did not participate in the evaluation and treatment) generates the random number sequence by block randomization

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

网络平台

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

webbased

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:

病例记录表

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

Case Record Form,CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-25
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