Major Depressive Disorder Clinical Trial
— STRINGOfficial title:
The Santiago Immigrant Wellbeing Study (STRING): Prevalence of Mood Disorders Among Immigrants in Santiago, Chile
Verified date | July 2020 |
Source | Pontificia Universidad Catolica de Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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:
1. 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.
2. A significant association will be observed between the loss of socio-economic position
after migration and a greater probability of major depressive disorder.
3. 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.
4. 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:
1. Primary sampling units (PSUs): conglomerates or groups of adjoining houses, organized in
spatial blocks (200 households on average)
2. Secondary sampling units (SSUs): individual households within each of the conglomerates
selected in the first stage
3. 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:
1. Sociodemographics
2. Finance
3. Variation in socioeconomic position
4. Experience of victimization
5. Discrimination
6. Experience of childhood adversity
Status | Completed |
Enrollment | 1092 |
Est. completion date | June 30, 2020 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Country of birth other than Chile - Time since arrival to Chile: 3 months Exclusion Criteria: - Unable to understand Spanish |
Country | Name | City | State |
---|---|---|---|
Chile | Pontificia Universidad Catolica de Chile | Santiago | RM |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile | Fondo Nacional de Desarrollo Científico y Tecnológico, Chile |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major Depressive Disorder | Assessed using the World Health Organisation Composite International Diagnostic Interview (WHO-CIDI) | baseline | |
Primary | Any affective/mood disorder | Assessed using the WHO-CIDI | baseline | |
Primary | Suicidal ideation, plans and attempts | Assessed using the WHO-CIDI | baseline | |
Primary | Depressive symptoms | 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 | |
Primary | Anxiety symptoms | 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 | Mental wellbeing | 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 | |
Secondary | Mental health service use | Assessed using items of the Services Module of the WHO-CIDI | baseline | |
Secondary | Hazardous/harmful drinking | Assessed using the Alcohol Use Disorders Identification Test (AUDIT) | baseline |
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