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临床试验/NCT04356365
NCT04356365已完成不适用

The Mental Health Status of the General Population During the COVID-19 Pandemic and Its Association With Adherence to Government-initiated Non-pharmacological Epidemiological Interventions (NPI's)

University of Oslo1 个研究点 分布在 1 个国家目标入组 10,084 人开始时间: 2020年3月31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
10,084
试验地点
1
主要终点
Measures of adherence

研究概览

简要总结

This study seeks to investigate the levels of common psychopathology symptoms (i.e., depression and generalized anxiety) in a general population during the strict social distancing government-initiated non-pharmacological interventions (NPI's) related to the COVID-19 pandemic. The study also seeks to examine the predictors of generalized anxiety and depressive symptoms, as well as predictors of adherence rates to government-initiated non-pharmacological epidemiological interventions (NPI's).

The aim of the project is to:

  • Inform the policymakers, the general public, scientists, and health practitioners about the psychological associations of the COVID-19-related government-initiated measures.
  • Provide a foundation for policymakers and health-care professionals to employ interventions that protect the general public against possibly increased psychological stressors, suffering and dysfunction during society's handling of the pandemic.
  • Help policymakers better understand the associations of demographic variables and psychological symptoms with adherence, providing an initial understanding of adherence rates, which may be used to help society fight against the COVID-19-virus from an epidemiological perspective by promoting factors that increase adherence.

详细描述

This study seeks to investigate the levels of common psychopathology symptoms (i.e., depression and generalized anxiety) in a general population during the strict social distancing government-initiated non-pharmacological interventions (NPI's) related to the COVID-19 pandemic. The study also seeks to examine the predictors of generalized anxiety and depressive symptoms, as well as predictors of adherence rates to government-initiated non-pharmacological epidemiological interventions (NPI's).

The aim of the project is to:

  • Inform the policymakers, the general public, scientists, and health practitioners about the psychological associations of the COVID-19-related government-initiated measures.
  • Provide a foundation for policymakers and health-care professionals to employ interventions that protect the general public against possibly increased psychological stressors, suffering and dysfunction during society's handling of the pandemic.
  • Help policymakers better understand the associations of demographic variables and psychological symptoms with adherence, providing an initial understanding of adherence rates, which may be used to help society fight against the COVID-19-virus from an epidemiological perspective by promoting factors that increase adherence.

Hypotheses related to general psychopathology - Depressive and anxiety symptom levels

  1. H1: Social distancing measures related to the pandemic (NPI's) are associated with increased depressive and generalized anxiety symptoms in the general population, as revealed through comparisons with prevalence rates of GAD and depression during from other benchmark studies with similar sample during non-pandemic periods.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • Eligible participants are all adults including those of 18 years and above,
  • Who are currently living in Norway and thus experiencing identical NPIs, and
  • Who had provided digital consent to partake in the study.

排除标准

  • Children and adolescents (individuals below 18)
  • Adults not residing in Norway during the measurement period

结局指标

主要结局

Measures of adherence

时间窗: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (non-pharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

Measures of adherence to all eight non-pharmacological interventions (NPIs) employed against COVID-19 is measured, with each item being on a five-point Likert scale (0-4).

Patient Health Questionnaire 9

时间窗: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (non-pharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

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 where each is 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 indicating that the patient is within the depressive area.

Generalized Anxiety Disorder 7

时间窗: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (non-pharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams \& Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Higher scores indicate greater anxiety severity, and scores that are above the cut-off of 10 are considered to be in the clinical range (Spitzer et al., 2006). Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen \& Hoffart, 2019).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omid Ebrahimi

Doctoral Research Fellow (PI)

University of Oslo

研究点 (1)

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