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临床试验/NCT04365881
NCT04365881已完成不适用

Loneliness During the Non-pharmacological Epidemiological Interventions for the COVID-19 Pandemic in Norway: Risk Factors and Associations With Psychopathology

Modum Bad1 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
发起方
Modum Bad
入组人数
10,084
试验地点
1
主要终点
UCLA Loneliness Scale-8 (ULS-8)

研究概览

简要总结

The present study of loneliness during the COVID-19-related NPIs is part of a larger project aiming to investigate psychological reactions and symptoms associated with the current and ongoing governmental initiatives in place in Norway.

The results will lead to a better understanding of the psychological effects on quarantine on the population and consequently will be relevant for the development of tailored prevention and intervention programs fit for pandemic crises.

Objectives Investigate the levels of loneliness in a general population during the strict social distancing government-initiated non-pharmacological interventions (NPIs) for the COVID-19 pandemic.

Investigate risk and resilience factors for loneliness and the associations between loneliness and psychopathology symptoms during the NPIs.

Aims Inform the general public, policy makers, scientists, and health practitioners about the associations of the NPIs with the mental health problem of loneliness and its potential effect on psychopathology.

Provide a foundation for policymakers and health-care professionals to employ interventions that protect the general public against increased psychological suffering and dysfunction during society's handling of pandemics.

详细描述

Objectives Investigate the levels of loneliness in a general population during the strict social distancing government-initiated non-pharmacological interventions (NPIs) for the COVID-19 pandemic.

Investigate risk and resilience factors for loneliness and the associations between loneliness and psychopathology symptoms during the NPIs.

Hypotheses (Hs) H1: The social distancing measures used to cope with the pandemic are associated with increased loneliness.

Exploratory: Investigate the differences in levels of loneliness across different demographic subgroups in the sample.

H2. With regard to risk factors existing before the NPIs, lower age, lower educational level, not being in a permanent relationship, not having children, not being in work, and having a psychological diagnosis will be associated with more loneliness during the NPIs when the potential effects of gender and childlessness are controlled.

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

  • all adults residing in Norway

排除标准

  • 未提供

结局指标

主要结局

UCLA Loneliness Scale-8 (ULS-8)

时间窗: From March31st 2020 to April 7th 2020

The UCLA Loneliness Scale-8 (ULS-8) measures the frequency and intensity of aspects of the lonely experience, using a 1 (never) to 4 (always) Likert-type scale. A composite score was computed by summing the items after reverse coding when appropriate, such that higher scores indicate greater loneliness. In terms of symptoms, validated measures routinely used in clinical practice to screen symptom-levels suggestive of psychiatric diagnosis were utilized.

Generalized Anxiety Disorder-7 (GAD-7)

时间窗: From March31st 2020 to April 7th 2020

The Generalized Anxiety Disorder-7 (GAD-7)17 consists of seven items covering the DSM-IV criteria for GAD on a four-point Likert scale (0-3) with scores ranging from 0 to 21. Higher scores reveal greater GAD symptoms, and scores above 10 are considered as the cut-off indicative of a GAD-diagnosis with a specificity of 82% and sensitivity of 89%.17 The GAD-7 has revealed construct validity and reliability (Kroenke, Spitzer, Williams, Monahan \& Löwe, 2007; Löwe et al., 2008).

Patient Health Questionnaire-9 (PHQ-9)

时间窗: From March31st 2020 to April 7th 2020

The Patient Health Questionnaire-9 (PHQ-9)16 consists of nine items covering the DSM-IV criteria for major depression scored on a four-point Likert-scale (0-3), with scores ranging from 0 to 27. High scores on the PHQ-9 reveal greater depression severity and scores above 10 are considered as the cut-off indicative of a depressive diagnosis with a sensitivity and specificity of 88%.16 The PHQ-9 has revealed good psychometric properties, as demonstrated by Kroenke et al. (2001).

次要结局

未报告次要终点

研究者

发起方
Modum Bad
申办方类型
Other
责任方
Sponsor

研究点 (1)

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