NCT04497636

Brief Summary

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. 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. 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. 3.Identify risk / protective factors associated with a short (T1) and long-term (T2) increase in mental health problems

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,092

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2021

Completed
Last Updated

November 16, 2021

Status Verified

August 1, 2020

Enrollment Period

10 months

First QC Date

August 1, 2020

Last Update Submit

November 15, 2021

Conditions

Keywords

MigrantsDepressionAnxietyCOVID-19Within-group longitudinal design

Outcome Measures

Primary Outcomes (2)

  • Depressive symptoms

    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

    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 Outcomes (7)

  • Symptoms of post-traumatic stress disorder

    Month 1 (T1) and month 10 (T2)

  • Changes in sleep difficulties

    Month 1 (T1) and month 10 (T2)

  • Changes in hazardous and harmful alcohol drinking

    Month 1 (T1) and month 10 (T2)

  • Changes in loneliness

    Month 1 (T1) and month 10 (T2)

  • Change in general physical and mental health

    Change from last 2 weeks before pandemic to month 1 (T1) and month 10 (T2)

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Unable to understand Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, RM, 7550139, Chile

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionStress, PsychologicalSocial IsolationCOVID-19

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorSocial BehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Antonia Errazuriz, PhD

    Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2020

First Posted

August 4, 2020

Study Start

July 3, 2020

Primary Completion

April 18, 2021

Study Completion

April 18, 2021

Last Updated

November 16, 2021

Record last verified: 2020-08

Locations