- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04114565
Prevalence of Major Depression Among Immigrants in Santiago, Chile (STRING)
The Santiago Immigrant Wellbeing Study (STRING): Prevalence of Mood Disorders Among Immigrants in Santiago, Chile
The general aim of this study is to explore the prevalence of major depressive disorder and the use of mental health services in the immigrant populations in the Metropolitan Region of Santiago, Chile.
The hypotheses are:
- A healthy immigrant effect will be observed in the studied population by which their prevalence of major depressive disorder will be lower than the prevalence in the general Chilean population.
- A significant association will be observed between the loss of socio-economic position after migration and a greater probability of major depressive disorder.
- A significant association will be observed between the report of victimization experience(s) in the previous year and a greater probability of major depressive disorder.
- A significant association will be observed between financial difficulties and a greater probability of major depressive disorder.
The sampling framework of the Chilean National Institute of Statistics (INE) from the 2016 Census will be used for the purpose of this research. The sampling units are as follows:
- Primary sampling units (PSUs): conglomerates or groups of adjoining houses, organized in spatial blocks (200 households on average)
- Secondary sampling units (SSUs): individual households within each of the conglomerates selected in the first stage
- Final sampling units: persons meeting the study's inclusion criteria Multi-stage random probability sampling involving a 3-stage sampling design will be used - first, the sampling of the primary sampling units (PSUs); second, the sampling of households within the selected PSUs and finally, the random sampling of a household member.
Participants (n=1,100) will then take part in a 45-minute interview. This interview will be a household survey using the modular version of the Composite International Diagnostic Interview (WHO-CIDI) looking at exploring a broad spectrum of factors traditionally associated with increased risk of affective disorders:
- Sociodemographics
- Finance
- Variation in socioeconomic position
- Experience of victimization
- Discrimination
- Experience of childhood adversity
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
RM
-
Santiago, RM, Chile, 7550139
- Pontificia Universidad Catolica de Chile
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Country of birth other than Chile
- Time since arrival to Chile: 3 months
Exclusion Criteria:
- Unable to understand Spanish
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Major Depressive Disorder
Time Frame: baseline
|
Assessed using the World Health Organisation Composite International Diagnostic Interview (WHO-CIDI)
|
baseline
|
|
Any affective/mood disorder
Time Frame: baseline
|
Assessed using the WHO-CIDI
|
baseline
|
|
Suicidal ideation, plans and attempts
Time Frame: baseline
|
Assessed using the WHO-CIDI
|
baseline
|
|
Depressive symptoms
Time Frame: baseline
|
Assessed using the nine-item Patient Health Questionnaire (PHQ-9). The PHQ-9 score can range from 0 to 27, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-19 Moderate to Severe; 20-27 Severe. |
baseline
|
|
Anxiety symptoms
Time Frame: baseline
|
Assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 score can range from 0 to 21, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-21 Severe. |
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental wellbeing
Time Frame: baseline
|
Assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The 14 Items are scored on a range from 1 to 5, providing a total score between 14 and 70 with higher values indicating higher mental well-being. |
baseline
|
|
Mental health service use
Time Frame: baseline
|
Assessed using items of the Services Module of the WHO-CIDI
|
baseline
|
|
Hazardous/harmful drinking
Time Frame: baseline
|
Assessed using the Alcohol Use Disorders Identification Test (AUDIT)
|
baseline
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17051004
- 96875479 (Registry Identifier: ISRCTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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