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临床试验/NCT04497636
NCT04497636已完成不适用

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

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 1,092 人开始时间: 2020年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,092
试验地点
1
主要终点
Depressive symptoms

研究概览

简要总结

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

详细描述

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)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Unable to understand Spanish

结局指标

主要结局

Depressive symptoms

时间窗: 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.

Symptoms of anxiety

时间窗: 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.

次要结局

  • Symptoms of post-traumatic stress disorder(Month 1 (T1) and month 10 (T2))
  • Changes in hazardous and harmful alcohol drinking(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))
  • Changes in loneliness(Month 1 (T1) and month 10 (T2))
  • Changes in sleep difficulties(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 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 from last 2 weeks before pandemic to month 1 (T1) and to month 10 (T2).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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