DepressionNCT02009358
Mental Health Promotion Interventions Among Migrant Workers in China
A study testing mental health promotion in people with Depression and Anxiety, run by Peking University.
Trial summary
The goals of this research were to conduct a mental health intervention study for reducing self-reported depression and anxiety among migrant workers in a labor-intensive industry in China and to assess the effectiveness of the integrated mental health interventions aimed at promoting the mental health of migrant… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- mental health promotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 913 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Nov 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People who worked in the factory agreed to take participant in this study and could understand the questionnaire.
Who cannot join
- People who don't want to take participant in the study; People can not understand the questionnaire.
About this study
Official title: Mental Health Promotion Interventions for Reducing Self-reported Depression and Improving Rates of Early Detection of Depression Among Migrant Workers in China, a Cluster Randomised Controlled Trial
The goals of this research were to conduct a mental health intervention study for reducing self-reported depression and anxiety among migrant workers in a labor-intensive industry in China and to assess the effectiveness of the integrated mental health interventions aimed at promoting the mental health of migrant workers in labor-intensive industries in China.
- Conditions
- Depression, Anxiety
- Being tested
- mental health promotion
- Keywords
- mental health promotion, depression, migrant workers, China
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mental health promotionOther
| Study group | Role | What they receive |
|---|---|---|
| Mental health promotion group | Experimental | Not described Receives: Other: mental health promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing rate of self-reported depression in BDI
Measured: Change from baseline to one year after
Secondary outcomes (1)
Reducing rate of early detection of depression
Measured: change from baseline to one year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startMar 2010
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 913 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Yu, Peking University
- Investigators
- Xin Yu, Professor, Study director, +86 13910229255
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009358
- Sponsor's protocol ID
- GCY2009
- Status last verified
- Dec 2013
- First submitted
- 3 Dec 2013
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Promotion Interventions for Reducing Self-reported Depression and Improving Rates of Early Detection of Depression Among Migrant Workers in China, a Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02009358
- Acronym / sponsor ID
- GCY2009
- Conditions
- Depression, Anxiety
- Keywords
- mental health promotion, depression, migrant workers, China
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 913 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 Dec 2013 (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 goals of this research were to conduct a mental health intervention study for reducing self-reported depression and anxiety among migrant workers in a labor-intensive industry in China and to assess the effectiveness of the integrated mental health interventions aimed at promoting the mental health of migrant workers in labor-intensive industries in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mental health promotion group | Experimental | Other: mental health promotion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- People who worked in the factory agreed to take participant in this study and could understand the questionnaire.
Key exclusion criteria (1 listed)
- People who don't want to take participant in the study; People can not understand the questionnaire.
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 |
|---|---|---|
| mental health promotion | Other | Mental health promotion group |
Primary outcome
Reducing rate of self-reported depression in BDI
Time frame: Change from baseline to one year after
1 secondary outcome
Reducing rate of early detection of depression
Time frame: change from baseline to one year after
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 Feb 2014.
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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.
Xin Yu, Professor study director
+86 13910229255
Questions about this trial
What is this clinical trial studying?
A study testing mental health promotion in people with Depression and Anxiety, run by Peking University.
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 1 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 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Reducing rate of self-reported depression in BDI (time frame: Change from baseline to one year after). 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 Feb 2014.