Condition category
Mental and Behavioural Disorders
Date applied
20/10/2018
Date assigned
30/10/2018
Last edited
21/11/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Evidence suggests that a personal or family history of migration is a psychologically stressful life event and a risk factor for developing psychotic disorders and schizophrenia in some ethnic minorities and/or immigrant populations. However, research on the potential influence of immigration on the prevalence of affective disorders (i.e. depression, bipolar disorder) is more limited and the evidence is more ambiguous. The general aim of this study is to explore the prevalence of affective disorders and use of mental health services on immigrant populations in the Metropolitan Region of Santiago in Chile.

Who can participate?
Adults residing in private households in the Metropolitan Region of Santiago, Chile who were born outside of Chile and have lived in the country for at least 6 months

What does the study involve?
A 45 minute face to face interview covering socioeconomic situation, immigration history, experience of victimization, discrimination, alcohol use, social support, mental wellbeing, affective disorders, depressive and anxiety symptoms and experience of childhood adversity.

What are the possible benefits and risks of participating?
There are no known benefits or risks of participating in this study.

Where is the study run from?
Department of Psychiatry, School of Medicine, Pontifical Catholic University of Chile (Chile)

When is the study starting and how long is it expected to run for?
October 2017 to October 2019

Who is funding the study?
Chilean National Commission for Scientific and Technological Research (CONICYT) (Chile)

Who is the main contact?
Antonia Errázuriz
anerrazuriz@uc.cl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Antonia Errazuriz

ORCID ID

Contact details

Departamento de Psiquiatría
Escuela de Medicina
Pontificia Universidad Católica de Chile
Diagonal Paraguay 362 piso 5
Santiago
8330077
Chile
+56953631333
anerrazuriz@uc.cl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Fondecyt 11170828

Study information

Scientific title

Prevalence of mood disorders and mental health service use among immigrants of the Metropolitan Region of Chile

Acronym

STRING

Study hypothesis

1. A healthy immigrant effect will be observed in the studied population by which their prevalence of Affective Disorders (AD) 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 AD in immigrants.
3. A significant association will be observed between the report of victimization experience(s) in the previous year and a greater probability of AD in immigrants.
4. A significant association will be observed between financial difficulties and a greater probability of AD in immigrants.

Ethics approval

1. Ethical Scientific Committee of the Social Sciences of the Pontifical Catholic University of Chile, 06/12/2017, ref: 170519004
2. Ethical Scientific Committee of the South Metropolitan Health Service of the Chilean Ministry of Health, 04/04/2018, ref: 145/2018

Study design

Observational epidemiological cross-sectional study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Affective/Mood Disorders

Intervention

The sampling framework of the Chilean National Institute of Statistics (INE) from the 2016 Census will be used in MRS and for the purpose of this research it included the following sampling units:
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 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) will be conducted to explore 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
Added 09/08/2019: 6. Experience of childhood adversity

Intervention type

Other

Phase

Drug names

Primary outcome measure

Major depressive episodes, assessed using the World Health Organisation Composite International Diagnostic Interview (WHO-CIDI) at the study interview

Secondary outcome measures

The following are assessed at the study interview:
1. Any affective disorder, assessed using the World Health Organisation Composite International Diagnostic Interview (WHO-CIDI)
2. Bipolar disorder, assessed using the WHO-CIDI
3. Suicidal ideation, plans and attempts, assessed using the WHO-CIDI
4. Mental health service use, assessed using items SR27, SR37, SR47, SR57, SR133, SR139, SR143 and SR149 of the Services Module of the WHO-CIDI
5. Discrimination, assessed using the Spanish-validated version of the Everyday Discrimination Scale (EDS)
6. Mental wellbeing, assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
7. Depressive symptoms, assessed using the nine-item Patient Health Questionnaire (PHQ-9)
8. Hazardous/harmful drinking, assessed using the Alcohol Use Disorders Identification Test (AUDIT)
9. Functional social support, assessed using the 11-item Duke-UNC Functional Social Support Questionnaire (FSSQ)

Added 09/08/2019:
10. Resilience assessed using the Connor-Davidson Resilience Scale (CD-RISC)
11. Childhood adversity using ítems from the Adverse Childhood Experience (ACE) Questionnaire
12. Anxiety symptoms assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale

Overall trial start date

01/10/2017

Overall trial end date

31/10/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Residents of the Metropolitan Area of Santiago (MAS), Chile
2. Born outside of Chile
3. Aged 18 or over
4. Lived in Chile for at least 3 months (updated 09/0/2019: for at least 6 months)
Added 09/08/2019: 5. Be able to provide informed consent (participants unable to understand Spanish will not be recruited)

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

1100

Total final enrolment

1098

Participant exclusion criteria

1. Inability to read and write
2. Suffering from disability or condition which makes participation in survey difficult
3. Both parents Chilean-born

Recruitment start date

01/08/2019

Recruitment end date

18/10/2019

Locations

Countries of recruitment

Chile

Trial participating centre

Department of Psychiatry, School of Medicine of the Pontifical Catholic University of Chile
Av Libertador Bernardo O'Higgins 340
Santiago
8331150
Chile

Sponsor information

Organisation

Pontifical Catholic University of Chile (Pontificia Universidad Catolica de Chile)

Sponsor details

Av Libertador Bernardo O'Higgins 340
Santiago
8331150
Chile
+5622 354 8170
didemuc@med.puc.cl

Sponsor type

University/education

Website

https://medicina.uc.cl/

Funders

Funder type

Government

Funder name

Comisión Nacional de Investigación Científica y Tecnológica

Alternative name(s)

National Commission for Scientific and Technological Research, CONICYT

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Chile

Results and Publications

Publication and dissemination plan

We intend to publish:
1. The study protocol in 2019
2. Cohort profile and prevalence estimates in 2019
3. Risk factors for affective disorders among immigrants in 2020

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Antonia Errazuriz (anerrazuriz@uc.cl). The anonymized database will be made available from 01/01/2022 to researchers from known research centers based upon the quality of the research proposal brought forward. Participants will give consent to this.

Intention to publish date

01/11/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/11/2019: The following changes have been made: 1. The recruitment end date has been changed from 31/10/2019 to 18/10/2019. 2. The final enrolment number has been added 3. The intention to publish date has been changed from 01/12/2019 to 01/11/2020. 09/08/2019: The interventions, secondary outcome measures and inclusion criteria were updated. 17/06/2019: The following changes were made to the trial record: 1. The recruitment start date was changed from 01/03/2019 to 01/08/2019. 2. The recruitment end date was changed from 31/05/2019 to 31/10/2019. 3. The overall end date was changed from 30/06/2019 to 31/10/2019. 4. The plain English summary was updated to reflect these changes. 13/05/2019: Internal review. 02/11/2018: Internal review.