AnxietyRPIMHPNCT01422447
Research of Prevention and Intervention of Mental Health Problems
A study testing regular intervention and community intervention in people with Anxiety and Depression, run by Shanghai Mental Health Center at 7 sites in China.
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. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Anxiety, Depression, Alcohol-abuse
- What is being tested?
- regular intervention and community intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42,016 participants
- Where
- 7 sitesChina
- Study dates
- Oct 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- those who have been diagnosed with depression,anxiety or alcohol abuse and other psychiatric disorders will be excluded from this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Capital Normal University
Beijing, Beijing Municipality
Harbin medical university
Harbin, Jilin
Mental Health Center in Hunan Province
Hunan, Hunan
中国
Shanghai, Shanghai Municipality, 200030
Shenzhen mental health center
Shenzhen, Guangdong
Mental Health of Sichuan Province
Sichuan, Sichuan
Mental Health of Xinjiang Province
Xinjiang, Xinjiang
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Depression, Alcohol-abuse
- Being tested
- regular intervention, community intervention
- Keywords
- mental health education, community-based
- Medical subject headings
- Anxiety Disorders, Depression, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular interventionOther
the subjects in the control group live in the used model
community interventionOther
in addition to regular intervention, those subjects in the intervention group will be given education intervention.
| Study group | Role | What they receive |
|---|---|---|
| community intervention | Experimental | Feedback on assessment results: distribute relevant brochures and hold regular lectures on depression, anxiety and alcohol-abuse. Receives: Other: community intervention |
| regular intervention control | Active comparator | the subjects in the control group live in the used model Receives: Other: regular intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
public awareness and attitude towards mental health knowledge
designed related questionnaires to investigate the public's awareness and attitude towards mental health knowledge.
Measured: 12 months
service needs and utilization
use qualitative research methods to ivestigate service needs and utilization of three target population in community.
Measured: 12 months
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
Measured: 6 months
assessment of the situation of community mental health service resources
we use scales to evaluate the situation of community mental health service resources
Measured: 1 month
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min ZHAO,, Ph.D., Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422447
- Sponsor's protocol ID
- MZhao-001
- Acronym
- RPIMHP
- Status last verified
- Nov 2015
- First submitted
- 18 Aug 2011
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Mental Health Education for Mental Health Problems in Community: A Model of Common Mental Health Problems in Seven Metropolis of China
- ClinicalTrials.gov ID
- NCT01422447
- Acronym / sponsor ID
- RPIMHP / MZhao-001
- Conditions
- Anxiety, Depression, Alcohol-abuse
- Keywords
- mental health education, community-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42,016 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| community intervention | Experimental | Other: community interventionFeedback on assessment results: distribute relevant brochures and hold regular lectures on depression, anxiety and alcohol-abuse. |
| regular intervention control | Active comparator | Other: regular interventionthe subjects in the control group live in the used model |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- those who have been diagnosed with depression,anxiety or alcohol abuse and other psychiatric disorders will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regular interventionthe subjects in the control group live in the used model | Other | regular intervention control |
| community interventionin addition to regular intervention, those subjects in the intervention group will be given education intervention. | Other | community intervention |
Primary outcome
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.
6 secondary outcomes
prevalence of depression,anxiety and alcohol abuse
Time frame: 12 months
public awareness and attitude towards mental health knowledge
Time frame: 12 months
service needs and utilization
Time frame: 12 months
the reliability and validity of PHQ-9, HPQ-7 and AUDIT
Time frame: 6 months
assessment of the situation of community mental health service resources
Time frame: 1 month
assessment the changes of early stage of mental disorders in population before and after intervention
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min ZHAO,, Ph.D. principal investigator
Shanghai Mental Health Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regular intervention and community intervention in people with Anxiety and Depression, run by Shanghai Mental Health Center at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the changes of mental health state of community residents before and after intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.