Mental Health Impact of the COVID-19 Pandemic Among Migrants in Chile (STRING-COVID)

November 15, 2021 updated by: Pontificia Universidad Catolica de Chile

Mental Health Impact of the COVID-19 Pandemic Among Immigrants in Santiago, Chile (STRING-COVID)

The mental health of a representative sample of immigrants residing in Santiago, Chile (STRING cohort) was assessed nine months prior to the COVID-19 pandemic (T0). Evidence suggests that social isolation affects mental health by increasing symptoms of anxiety and depression. One of the main components of the current COVID-19 pandemic is the social isolation imposed on the population. This study seeks to explore the short (T1) and long-term (T2) effects of the pandemic on the psychological wellbeing of the cohort.

Specific aims are to

  1. Describe the variations in the levels of mental health problems (i.e. symptoms of depression, anxiety, post-traumatic stress, sleep difficulties) and wellbeing of immigrants during the first (T1) and second follow-up (T2)
  2. Calculate the short (T1) and long-term (T2) effects of social isolation on the levels of mental health problems of the immigrant population, and
  3. Identify risk / protective factors associated with a short (T1) and long-term (T2) increase in mental health problems

Study Overview

Detailed Description

Participants were interviewed at baseline (T0) 8 months before the COVID-19 pandemic. An online survey will be applied in two follow-up moments during the pandemic:

  1. At 9 months (also 1 month after lockdown measures imposed) (T1)
  2. At 18 months (also 10 months after lockdown measures imposed) (T2)

Study Type

Observational

Enrollment (Actual)

1092

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • RM
      • Santiago, RM, Chile, 7550139
        • Pontificia Universidad Catolica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The STRING cohort is comonsed of 1,092 adults residing in private households in the Metropolitan Region of Santiago, Chile who were born outside of Chile and had lived in the country for at least 3 months in the first wave.

Description

Inclusion Criteria:

  • Country of birth other than Chile
  • Time since arrival to Chile: 3 months (at baseline)

Exclusion Criteria:

  • Unable to understand Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: Month 1 (T1) and month 10 (T2)

The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicate that the patient is within the depressive area. Specific cut-off for primary care samples in Chile have been found yielding a cut-off of 7 and above for high sensitivity and specificity (Saldivia, Aslan, Cova, Vicente, Inostroza & Rincón, 2019).

Changes in depressive symptoms between baseline (T0) and two follow-up points (T1 and T2) will be assessed.

Month 1 (T1) and month 10 (T2)
Symptoms of anxiety
Time Frame: Month 1 (T1) and month 10 (T2)

The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is used to measure symptoms of anxiety and worry. The questionnaire consists of seven items scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for primary care samples in Spain have been found yielding a cut-off of 10 and above for high sensitivity and specificity (García-Campayo et al, 2010).

Changes in symptoms of anxiety between baseline (T0) and two follow-up points (T1 and T2) will be assessed.

Month 1 (T1) and month 10 (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of post-traumatic stress disorder
Time Frame: Month 1 (T1) and month 10 (T2)

The Impact of Events Scale (IES-R; Weiss & Marmar, 1997) is used to measure symptoms of post-traumatic stress disorder (PTSD). There scale consists of 22 questions which are scored on a five-point Likert scale (0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, 4=extremely). There are three subscales (i.e., avoidance, intrusion, hyperarousal) and the sum of the three subscales scores comprise the total score. A total score ≥33 indicates the likely presence of PTSD using criteria from the Diagnostic Symptom Manual (DSM-IV).

Changes in symptoms of post-traumatic stress between the two follow-up points (T1 and T2) will be assessed.

Month 1 (T1) and month 10 (T2)
Changes in sleep difficulties
Time Frame: Month 1 (T1) and month 10 (T2)

The Insomnia Severity Index (ISI; Bastein CH, et al. 2001) is used to assess the nature, severity, and impact of sleep difficulties. The questionnaire consists of 7 items scored on a five-point Likert scale (0=no problem, 4=very severe problem) with scores ranging from 0 to 28.

Changes in symptoms sleep difficulties between the two follow-up points (T1 and T2) will be assessed.

Month 1 (T1) and month 10 (T2)
Changes in hazardous and harmful alcohol drinking
Time Frame: Month 1 (T1) and month 10 (T2)
Using the three-item Alcohol Use Disorders Identification Test (AUDIT-C). Changes in hazardous and harmful alcohol drinking between baseline (T0) and two follow-up points (T1 and T2) will be assessed.
Month 1 (T1) and month 10 (T2)
Changes in loneliness
Time Frame: Month 1 (T1) and month 10 (T2)

Using the three-item Revised UCLA Loneliness Scale. Scores range from 3 to 9 with higher scores indicating higher perceived loneliness.

Changes in perceived loneliness between the two follow-up points (T1 and T2) will be assessed.

Month 1 (T1) and month 10 (T2)
Change in general physical and mental health
Time Frame: Change from last 2 weeks before pandemic to month 1 (T1) and month 10 (T2)

Change in general physical and mental health, self-rated, on a VAS scale from 0 to 100. Higher scores indicate worse self-reported health.

Changes in perceived general physical and mental health between the two follow-up points (T1 and T2) will be assessed.

Change from last 2 weeks before pandemic to month 1 (T1) and month 10 (T2)
Change in mental health symptoms from last 2 weeks before the pandemic to the last 2 weeks during the COVID-19 pandemic at T1 and T2.
Time Frame: Change from last 2 weeks before pandemic to month 1 (T1) and to month 10 (T2).
Change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms in the last 2 weeks compared to the last 2 weeks of "regular life" before the COVID-19 outbreak.
Change from last 2 weeks before pandemic to month 1 (T1) and to month 10 (T2).
Change in mental health well-being from last 2 weeks before the pandemic to the last 2 weeks during the COVID-19 pandemic at T1 and T2.
Time Frame: Change from last 2 weeks before pandemic to month 1 (T1) and to month 10 (T2).
Change in World Health Organization (WHO)-5 well-being in the last 2 weeks compared to the last 2 weeks of "regular life" before the COVID-19 outbreak.
Change from last 2 weeks before pandemic to month 1 (T1) and to month 10 (T2).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 3, 2020

Primary Completion (ACTUAL)

April 18, 2021

Study Completion (ACTUAL)

April 18, 2021

Study Registration Dates

First Submitted

August 1, 2020

First Submitted That Met QC Criteria

August 1, 2020

First Posted (ACTUAL)

August 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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