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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01422447
Other study ID # MZhao-001
Secondary ID
Status Completed
Phase N/A
First received August 18, 2011
Last updated November 24, 2015
Start date October 2010
Est. completion date December 2012

Study information

Verified date November 2015
Source Shanghai Mental Health Center
Contact n/a
Is FDA regulated No
Health authority China: Ethics CommitteeUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this research is to establish a suitable community-based model for Chinese culture,to improve the community recognition of common mental disorders,as well as its treatment and control.


Description:

The project will select seven metropolis,through multi-center collaborative research,use of interdisciplinary methods and combining qualitative and quantitative research methods.Community resources will be integrated so as to build the Chinese model of community mental health services and to establish the routine for common mental disorders. Evaluation criteria for community mental health needs to be developed for the process of health education and intervention techniques.


Recruitment information / eligibility

Status Completed
Enrollment 42016
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 65 Years
Eligibility Inclusion Criteria:

1. general population: 13-65-year-old,

2. high-risk groups: not yet shown symptoms of mental disorders, but exposed to epidemiological risk factors for anxiety,depression and alcohol abuse.A part may be at risk for future depression,anxiety and alcohol abuse,for example: post-disaster population,Stress-related groups, the unemployed and laid-off people, high risk of psychological disorders (chronic treatment of various medical institutions and disabled, the mentally ill family members).

3. early stage of mental disorders in population:the subjects have the problem of depression, anxiety or alcohol abuse, but not yet diagnosed with depression, anxiety disorders or alcohol abuse.

Exclusion Criteria:

those who have been diagnosed with depression,anxiety or alcohol abuse and other psychiatric disorders will be excluded from this study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
regular intervention
the subjects in the control group live in the used model
community intervention
in addition to regular intervention, those subjects in the intervention group will be given education intervention.

Locations

Country Name City State
China Capital Normal University Beijing Beijing
China Harbin medical university Harbin Jilin
China Mental Health Center in Hunan Province Hunan Hunan
China ?? Shanghai Shanghai
China Shenzhen mental health center Shenzhen Guangdong
China Mental Health of Sichuan Province Sichuan Sichuan
China Mental Health of Xinjiang Province Xinjiang Xinjiang

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary evaluate the changes of mental health state of community residents before and after intervention we will use several scales such as SRHMS,SE,SEI,PSS,SCSQ,PHQ,AUDIT,scale of mental health knowledge and attitude survey and suicide related problems to evaluate the effect of our intervention. 12 months No
Secondary prevalence of depression,anxiety and alcohol abuse use scales of PHQ-9,PHQ-7 and AUDIT to investigate prevalence of depression,anxiety and alcohol abuse. 12 months No
Secondary public awareness and attitude towards mental health knowledge designed related questionnaires to investigate the public's awareness and attitude towards mental health knowledge. 12 months No
Secondary service needs and utilization use qualitative research methods to ivestigate service needs and utilization of three target population in community. 12 months No
Secondary the reliability and validity of PHQ-9, HPQ-7 and AUDIT use MINI as the gold standard to evaluate the reliability and validity of PHQ-9, HPQ-7 and AUDIT in community and university students 6 months No
Secondary assessment of the situation of community mental health service resources we use scales to evaluate the situation of community mental health service resources 1 month No
Secondary assessment the changes of early stage of mental disorders in population before and after intervention we will use several sacles such as assessment scale of motivation changes,alclhol behavior and willingness and confidence of abstain from drinking to evaluate the changes before and after intervention with people who have alcohol abuse problems and use SAS,SDS and IBS to evaluate the changes in people who have depression and anxiety problems. 3 months No
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