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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04114565
Other study ID # 17051004
Secondary ID 96875479
Status Completed
Phase
First received
Last updated
Start date July 29, 2019
Est. completion date June 30, 2020

Study information

Verified date July 2020
Source Pontificia Universidad Catolica de Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Chile Pontificia Universidad Catolica de Chile Santiago RM

Sponsors (2)

Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Country where clinical trial is conducted

Chile, 

Outcome

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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