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临床试验/NCT04444115
NCT04444115Unknown不适用

Loneliness During the COVID-19 Pandemic: Change and Predictors of Change From Strict to Lifted Social Distancing Protocols

Modum Bad0 个研究点目标入组 10,084 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
发起方
Modum Bad
入组人数
10,084
主要终点
UCLA Loneliness Scale-8 (ULS-8)

研究概览

简要总结

Description The aim of the present study is to investigate (a) changes in the levels of loneliness in the general adult population from a period of strict distancing protocols designed to impede transmission of the corona virus (T1) to a later period of lifted distancing protocols period (T2), (b) the risk and resilience factors for persistence in loneliness across these periods and (c) the associations between loneliness at T1 and changes in loneliness from T1 to T2 and changes in psychopathology symptoms from T1 to T2.

An investigation of loneliness persistence in addition to its association with risk factors and the persistence of psychopathology provides a knowledge basis for employing interventions that protect the general public against increased distress and dysfunction during and after society's handling of pandemics.

详细描述

Hypotheses and research questions:

The hypotheses (Hs) and explorative research questions of the present study were:

H1: The lifting of the social distancing protocols are associated with decreased loneliness. Exploratory question 1. What is the proportion showing a reliable change in loneliness? Exploratory question 2. What are the associations of the stable (demographic) factors age, gender, educational level, civil status, employment status, psychiatric diagnosis status and refugee status with change in loneliness from T1 to T2? H2: Of psychological factors, higher level at T1 and less reduction from T1 to T2 in worry about job and/or economy, worry about health (health anxiety), maladaptive mental and behavioral coping, and negative and positive metacognitions will be associated with less reduction in loneliness from T1 to T2, above and beyond the influence of pre-existing stable risk factors.

Explorative question 3. What are the potential protective effects of doing new positive activities at home, experiencing nature and performing aerobic physical exercise? That is, is higher level at T1 and more increase from T1 and T2 of these activities related to more reduction of loneliness from T1 to T2? H3: More loneliness at T1 will be associated with less reduction of depressive and anxiety symptoms from T1 to T2. Less reduction in loneliness from T1 to T2 will be associated with less reduction of symptoms in the same time frame. Because variables related to loneliness may confound the relationship between loneliness and psychopathology symptoms, the variables showing significant associations for Hypothesis 2 and 3 will be controlled for. However, psychiatric diagnosis will not be included as a control variable because T1 level of depression and anxiety symptoms is controlled.

Study design and participants The design is a longitudinal observational survey of the general adult Norwegian population during the COVID-19 pandemic. Eligible participants are all individuals of 18 years and above, who are living in Norway and thus experience identical distancing protocols, and who provide informed consent to participate in the study. The strict distancing protocols were implemented in Norway at March 12. 2020 and the first data collection in this period has already been done. It lasted seven days and was between March 31st 2020 and April 7th 2020. Thus, the strict protocols had been held constant during the two weeks prior to data collection, as well as during the data collection week. Furthermore, no new information was given by the government during this period with regard to changes of distancing protocols, keeping expectation effects constant. From June 15., the majority of the strict distancing protocols will be lifted in Norway, and lifted distancing protocol period is defined from this date. Data are set to be collected from the sample providing data in the first collection (N = 10 084), starting one week after the lifting data, that is, from 22th of June. The collection will last until enough data has been collected, but no longer than three weeks.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
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

  • 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 22nd of June to 13th of July

The UCLA Loneliness Scale-8 (ULS-8; Hays \& DiMatteo, 1987) measures the frequency and intensity of aspects of the lonely experience, using a 1 (never), 2 (rarely), 3 (sometimes) and 4 (often) scale. A composite score is computed by summing the items after reverse coding when appropriate, with composites ranging from 8 to 32. A score greater than half the maximum score (16) has been used to indicate caseness (Shevlin, Murphy, Mallett, Stringer, \& Murphy, 2013). This implies that respondents at least sometimes experience at least one of the loneliness aspects described in the 8 items. The ULS-8 has demonstrated good psychometric properties (Hays \& DiMatteo, 1987; Hartshorne, 1993).

Patient Health Questionnaire-9 (PHQ-9)

时间窗: From 22nd of June to 13th of July

The Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, \& Williams, 2001) consists of nine items covering the DSM-IV criteria for major depression scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 27. The PHQ-9 has revealed good psychometric properties, as demonstrated by Kroenke, Spitzer, and Williams (2001).

Generalized Anxiety Disorder-7 (GAD-7)

时间窗: From 22nd of June to 13th of July

The Generalized Anxiety Disorder-7 (GAD-7; Kroenke, Spitzer, Williams, Monahan \& Löwe, 2007) consists of seven items covering the DSM-IV criteria for GAD scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 21. The GAD-7 has revealed construct validity and reliability (Kroenke et al., 2007; Löwe et al., 2008).

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
Principal Investigator
主要研究者

Asle Hoffart

Prof

Modum Bad

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