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临床试验/NCT04444713
NCT04444713Unknown不适用

Centrality in the Cross-sectional Network of Depressive Symptom and Metacognitive Variables During COVID-19: Do Central Variables Predict Overall Symptom Reduction From Periods of 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
Cognitive-Attentional Syndrome-1 (CAS-1)

研究概览

简要总结

The aim of the study is to identify symptom-level intervention targets for depression related to the COVID-19 outbreak. First, we will assess centrality indices of the network of depression symptoms plus mechanism variables derived from the metacognitive model of psychopathology measured at a period of strict social distancing protocols (T1). Then, we will examine whether change in the most central symptom and metacognitive variables are more related to overall symptom reduction from the period of strict (T1) to a period of lifted social distancing protocols (T2) three months later. On the basis of the results, interventions can be suggested that protect the general public against increased psychological suffering and dysfunction during society's handling of pandemics.

详细描述

Hypotheses (Hs) H1: In the cross-sectional depression-metacognitive network at T1, the symptoms depressed mood, little interest/pleasure, and self-blame and the metacognitive coping variables rumination/worry, threat monitoring, situational avoidance, thought suppression, and uncontrollability of thoughts will be the most central variables.

H2: Reductions of the most central variables of the cross-sectional network from T1 to T2 will be more related to overall reduction of symptoms in the same time frame than reductions of the less central variables.

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. For this study, only participants reaching the cut-off value (>= 5; Kroenke et al, 2001) for subclinical symptoms on the PHQ-9 at T1 will be included, amounting to 6 508 individuals. The strict social distancing protocols were implemented in Norway at March 12. 2020 and the first data collection in this period (T1) 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 distancing protocols will be lifted in Norway, and the T2 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 of the protocols, that is, from 22th of June. The collection will last until enough data has been collected, but no longer than three weeks.

Ethical approval of the study was granted by The Regional Committee for Medical and Health Research Ethics and the Norwegian Centre for Research Data (reference numbers: 125510 and 802810, respectively, for the first data collection, and , respectively for the second data collection), where the study protocol and analysis plan was approved prior to data collection. The study is conducted in accordance with the guidelines of the Strengthening the Reporting of Observational Studies in Epidemiology statement (STROBE; Von Elm et al., 2007). The pre-registered protocol for a study of loneliness based on the first (T1) data collection can be found at Clinicaltrials.gov (Identifier: NCT04365881). The study is part of The Norwegian COVID-19, Mental Health and Adherence Project (Ebrahimi, Hoffart, & Johnson, 2020).

Procedures The survey is disseminated online. At T1, it was disseminated in a systematic manner to give the adult population an equal opportunity to participate in the study. The dissemination procedure involved information about the survey through broadcasting on national, regional, and local news channels and provision of the online survey to a random selection of Norwegian adults on Facebook. The dissemination procedure is described in detail elsewhere (Ebrahimi et al., 2020).

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 during the government-initiated interventions for the COVID-19 pandemia

排除标准

  • 未提供

结局指标

主要结局

Cognitive-Attentional Syndrome-1 (CAS-1)

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

The Cognitive Attentional Syndrome-1 (CAS-1; Wells, 2009) measures maladaptive mental and behavioral coping with thoughts and feelings (8 items, 0-8 scales) and negative and positive metacognitions (8 items, 0-100 scales). The CAS-1 has proved to have satisfactory psychometric properties (Nordahl \& Wells, 2019).

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).

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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