Research of Prevention and Intervention of Mental Health Problems (RPIMHP)

November 24, 2015 updated by: Shanghai Mental Health Center

Prevention and Mental Health Education for Mental Health Problems in Community: A Model of Common Mental Health Problems in Seven Metropolis of China

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42016

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Capital Normal University
    • Guangdong
      • Shenzhen, Guangdong, China
        • Shenzhen mental health center
    • Hunan
      • Hunan, Hunan, China
        • Mental Health Center in Hunan Province
    • Jilin
      • Harbin, Jilin, China
        • Harbin Medical University
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • 中国
    • Sichuan
      • Sichuan, Sichuan, China
        • Mental Health of Sichuan Province
    • Xinjiang
      • Xinjiang, Xinjiang, China
        • Mental Health of Xinjiang Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: community intervention
Feedback on assessment results: distribute relevant brochures and hold regular lectures on depression, anxiety and alcohol-abuse.
Other: community intervention
in addition to regular intervention, those subjects in the intervention group will be given education intervention.
Active Comparator: regular intervention control
the subjects in the control group live in the used model
Other: regular intervention
the subjects in the control group live in the used model

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
evaluate the changes of mental health state of community residents before and after intervention
Time Frame: 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
prevalence of depression,anxiety and alcohol abuse
Time Frame: 12 months
use scales of PHQ-9,PHQ-7 and AUDIT to investigate prevalence of depression,anxiety and alcohol abuse.
12 months
public awareness and attitude towards mental health knowledge
Time Frame: 12 months
designed related questionnaires to investigate the public's awareness and attitude towards mental health knowledge.
12 months
service needs and utilization
Time Frame: 12 months
use qualitative research methods to ivestigate service needs and utilization of three target population in community.
12 months
the reliability and validity of PHQ-9, HPQ-7 and AUDIT
Time Frame: 6 months
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
assessment of the situation of community mental health service resources
Time Frame: 1 month
we use scales to evaluate the situation of community mental health service resources
1 month
assessment the changes of early stage of mental disorders in population before and after intervention
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mental Health Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Min ZHAO,, Ph.D., Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MZhao-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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