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AnxietySTRING-COVIDNCT04497636

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

An observational study of Anxiety and Depression, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety, Depression, Stress, Psychological
How many people
1,092 participants
Where
1 siteChile
Study dates
3 Jul 2020to 18 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Unable to understand Spanish

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Pontificia Universidad Catolica de Chile

    Santiago, RM, 7550139

Other trials in Chile

About this study

Official title: 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
Read the 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)
Keywords
Migrants, Depression, Anxiety, COVID-19, Within-group longitudinal design
Medical subject headings
Anxiety Disorders, Depression, Stress, Psychological, Social Isolation, COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 1 (T1) and month 10 (T2)

  2. 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.

    Measured: Month 1 (T1) and month 10 (T2)

Secondary outcomes (7)

  1. Symptoms of post-traumatic stress disorder

    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.

    Measured: Month 1 (T1) and month 10 (T2)

  2. Changes in sleep difficulties

    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.

    Measured: Month 1 (T1) and month 10 (T2)

  3. Changes in hazardous and harmful alcohol drinking

    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.

    Measured: Month 1 (T1) and month 10 (T2)

  4. Changes in loneliness

    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.

    Measured: Month 1 (T1) and month 10 (T2)

  5. Change in general physical and mental health

    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.

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

  6. 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.

    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.

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

  7. 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.

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2020
  2. Study start3 Jul 2020
  3. Primary completion18 Apr 2021
  4. Study completion18 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,092 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04497636
Sponsor's protocol ID
170519004
Acronym
STRING-COVID
Status last verified
Aug 2020
First submitted
1 Aug 2020
Last updated
16 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anxiety and Depression, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depressive symptoms (time frame: Month 1 (T1) and month 10 (T2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04497636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.

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