NCT01422447

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42,016

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable anxiety

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 25, 2015

Status Verified

November 1, 2015

Enrollment Period

2.2 years

First QC Date

August 18, 2011

Last Update Submit

November 24, 2015

Conditions

AnxietyDepressionAlcohol-abuse

Keywords

mental health educationcommunity-based

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • prevalence of depression,anxiety and alcohol abuse

    12 months

  • public awareness and attitude towards mental health knowledge

    12 months

  • service needs and utilization

    12 months

  • the reliability and validity of PHQ-9, HPQ-7 and AUDIT

    6 months

  • assessment of the situation of community mental health service resources

    1 month

  • +1 more secondary outcomes

Study Arms (2)

community intervention

EXPERIMENTAL

Feedback on assessment results: distribute relevant brochures and hold regular lectures on depression, anxiety and alcohol-abuse.

Other: community intervention

regular intervention control

ACTIVE COMPARATOR

the subjects in the control group live in the used model

Other: regular intervention

Interventions

regular interventionOTHER

the subjects in the control group live in the used model

regular intervention control
community interventionOTHER

in addition to regular intervention, those subjects in the intervention group will be given education intervention.

community intervention

Eligibility Criteria

Age13 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • general population: 13-65-year-old,
  • 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).
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Capital Normal University

Beijing, Beijing Municipality, China

Location

Shenzhen mental health center

Shenzhen, Guangdong, China

Location

Mental Health Center in Hunan Province

Hunan, Hunan, China

Location

Harbin medical university

Harbin, Jilin, China

Location

中国

Shanghai, Shanghai Municipality, 200030, China

Location

Mental Health of Sichuan Province

Sichuan, Sichuan, China

Location

Mental Health of Xinjiang Province

Xinjiang, Xinjiang, China

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionAlcoholism

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Min ZHAO,, Ph.D.

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2011

First Posted

August 24, 2011

Study Start

October 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 25, 2015

Record last verified: 2015-11

Locations

CN(7)