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临床试验/NCT04442204
NCT04442204Unknown不适用

Predictors and Mechanisms of Depression and Anxiety During the COVID-19 Pandemic

University of Oslo0 个研究点目标入组 4,000 人开始时间: 2020年6月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
4,000
主要终点
Patient Health Questionnaire 9

研究概览

简要总结

Study description:

The present study seeks to investigate the predictors and maintaining mechanisms of depression and anxiety symptoms during the COVID-19 pandemic, exactly 3 months following the strictest viral mitigation strategies initiated in Norway in response to the pandemic. This is the time period where the major pandemic protocols are lifted in Norway, following three months of strict pandemic mitigation protocols. The study further aims to identify subgroups with highest levels of depressive and anxiety symptoms during the measurement period, to identify vulnerable subgroups with maintained symptoms three months following the pandemic.

Hypotheses and research questions:

Research Question 1: What is the level of depressive and anxiety symptoms three months following the employment of the strict viral mitigation protocols (i.e., physical distancing protocols) in the general adult population? What are the proportion above the validated cut-offs for depression and general anxiety? Hypothesis 1: There will be a significant decrease in the levels of depression and anxiety symptoms from the baseline (T1) with the strictest mitigation protocols to measurement the measurement period three months into pandemic (T2) where major pandemic mitigation protocols are lifted. Additionally, there will be a significant decrease in the proportion of the sample meeting validated cut-offs for depression and anxiety from T1 to T2.

Hypothesis 2: Higher level at T1 and less reduction from T1 to T2 in positive metacognitions, negative metacognitions, and unhelpful coping strategies all measured with CAS-1, will be related to less reduction in depression and anxiety, above and beyond age, gender, and education. Higher level at T1 and increases from T1 to T2 in physical activity and perceived competence will be related to greater reduction in depression and anxiety, above and beyond, age, gender, and education.

Exploratory: The investigators will further explore the proportion showing reliable change in depression and anxiety and investigate the differences in changes in depression and anxiety across different demographic subgroups in the sample

详细描述

Hypotheses and research questions:

Research Question 1: What is the level of depressive and anxiety symptoms three months following the employment of the strict viral mitigation protocols (i.e., physical distancing protocols) in the general adult population? What are the proportion above the validated cut-offs for depression and general anxiety? Hypothesis 1: There will be a significant decrease in the levels of depression and anxiety symptoms from the baseline (T1) with the strictest mitigation protocols to measurement the measurement period three months into pandemic (T2) where major pandemic mitigation protocols are lifted. Additionally, there will be a significant decrease in the proportion of the sample meeting validated cut-offs for depression and anxiety from T1 to T2.

Hypothesis 2: Higher level at T1 and less reduction from T1 to T2 in positive metacognitions, negative metacognitions, and unhelpful coping strategies all measured with CAS-1, will be related to less reduction in depression and anxiety, above and beyond age, gender, and education. Higher level at T1 and increases from T1 to T2 in physical activity and perceived competence will be related to greater reduction in depression and anxiety, above and beyond, age, gender, and education.

Explorative: The investigators will further explore the proportion showing reliable change in depression and anxiety and investigate the differences in changes in depression and anxiety across different demographic subgroups in the sample.

Statistical analyses:

研究设计

研究类型
Observational
观察模型
Other
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

  • Eligible participants are all adults including those of 18 years and above,
  • Who are currently living in Norway and thus experiencing identical viral mitigation protocols, and
  • Who provide 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

Patient Health Questionnaire 9

时间窗: Data is set to be collected starting from 22nd of June until enough data has been collected.The data collection period will last no longer than three weeks.

• 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: Data is set to be collected starting from 22nd of June until enough data has been collected.The data collection period will last no longer than three weeks.

• 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. 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 V. Ebrahimi

Mr.

University of Oslo

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