An observational study in Anxiety, Depression and Stress, Psychological, sponsored by Pontificia Universidad Catolica de Chile. Completed at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-16.
Sponsored by Pontificia Universidad Catolica de Chile · Observational
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
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:
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 1,092 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
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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.
Exclusion Criteria:
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.
Time frame: 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.
Time frame: Month 1 (T1) and month 10 (T2)
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.
Time frame: Month 1 (T1) and month 10 (T2)
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.
Time frame: Month 1 (T1) and month 10 (T2)
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.
Time frame: Month 1 (T1) and month 10 (T2)
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.
Time frame: Month 1 (T1) and month 10 (T2)
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: Change from last 2 weeks before pandemic to month 1 (T1) and to month 10 (T2).
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Pontificia Universidad Catolica de Chile