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Randomised-controlled study on effectiveness of the Multidisciplinary Assessment and Psychosocial Intervention Program (MAP)

注册号:

Registration number:

ChiCTR-TRC-12002629 

注册号获得时间:

Date of releasing the registration number:

2012/10/27 

注册号状态:

补注册 

Registration Status:

Retrospective registration 

注册题目:

 

Public title:

Randomised-controlled study on effectiveness of the Multidisciplinary Assessment and Psychosocial Intervention Program (MAP) 

研究课题的正式科学名称:

 

Scientific title:

Randomized- controlled study of the effectiveness of a new psychiatric specialist outpatient service model - the Multidisciplinary Assessment and Psychosocial intervention Program (MAP) vs standard psychiatric out-patient care. 

研究课题代号(代码):

Study subject ID:

CRE-2011.583-T 

在其它机构的注册号:

Secondary ID:

CRE-2011.583-T 

申请注册联系人:

 

研究负责人:

 

Applicant:

Li Suk Man, Connie 

Study leader:

Wei Lin 

申请注册联系人电话:

Applicant telephone:

+852 93049220, 26321615 

研究负责人电话:

Study leader's telephone:

+852 26367754 

申请注册联系人传真 :

Applicant Fax:

+852 26324656 

研究负责人传真:

Study leader's fax:

+852 26475321 

申请注册联系人电子邮件:

Applicant E-mail:

lsm581@ha.org.hk 

研究负责人电子邮件:

Study leader's E-mail:

lw395@ha.org.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:

 

研究负责人通讯地址:

 

Applicant address:

Department of Clinical Psycholgy, Room 301, Block B, Staff Quarters, Prince of Wales Hospital, Shatin, Hong Kong 

Study leader's address:

Department of Psychiatry, 7/F Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, N.T. 

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:

 

Applicant's institution:

Prince of Wales Hospital 

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:

CRE-2011.583-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:

 

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:

2012/05/22 

研究实施负责(组长)单位:

 

Primary sponsor:

nil 

研究实施负责(组长)单位地址:

 

Primary sponsor's address:

nil 

试验主办单位(项目批准或申办者):

Secondary sponsor:

未填写任何试验主办单位。

No data added。

经费或物资来源:

 

Source(s) of funding:

nil 

研究疾病:

 

Target disease:

Common Mental Disorders e.g. Anxiety, Depression 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

I期临床试验 

Study phase:

Phase I 

研究目的:

 

Objectives of Study:

To compare symptomatic and functional outcomes of patients undergoing the Multidisciplinary Assessment and Psychosocial Intervention Program (MAP) versus standard psychiatric out-patient care. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

 

Inclusion criteria

All consecutive new referrals, aged 18 to 64, to the Li Ka Shing Psychiatric Outpatient Clinic, falling into ‘Category III’ from standard Hospital Authority clinic triage procedures (non-urgent cases with no active psychosis, no indicators of suicidality or violence) who gives informed written consent are recruited. 

排除标准:

 

Exclusion criteria:

Patients with the following conditions will be excluded from the study: literacy,Psychosis, mental retardation, organic brain syndromes, critical medical conditions and sub-specialty service referrals including sleep disorders clinic, pregnancy, sexual dysfunction, and substance abuse services. 

研究实施时间:

Study execute time:

From2012-7-2To 2014-7-31 

干预措施:

Interventions:

组别:

样本量:

100

Group:

Experimental group

Sample size:

干预措施:

干预措施代码:

Intervention:

Drug treatment and time-limited psychosocial intervention from MAP team

Intervention code:

组别:

样本量:

100

Group:

Control group

Sample size:

干预措施:

干预措施代码:

Intervention:

Standard care (from General Adult team)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

 

省(直辖市):

 

市(区县):

 

Country:

China 

Province:

Hong Kong 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

Chinese University of Hong Kong 

Level of the institution:

测量指标:

Outcomes:

指标中文名:

Outcome:

Global psychiatric symptom scores (SCL-90R global severity index)

指标中文名:

Outcome:

Quality of life (SF-36) scores

指标中文名:

Outcome:

Clinical Global Impressions Scale)

指标中文名:

Outcome:

Hospital Anxiety and Depression Scale

指标中文名:

Outcome:

Patient Satisfaction Scale

采集人体标本:

Collecting sample(s)
from participants:

未填写任何采集标本。

No sample added。

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

随机方法(请说明由何人用什么方法产生随机序列):

性别:

男女均可

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

Patients will receive information about the design and procedure of the study during the clinical sc

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

Data collection Institution:

Department of Psychiatry, The Prince of Wales Hospital

资料管理单位:

Data management Institution:

Department of Psychiatry, The Prince of Wales Hospital

资料分析单位:

Data analysis Institution:

Department of Psychiatry, The Prince of Wales Hospital

创建人:

Creater Name:

Connie Li 2012/9/19 9:45:11
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