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临床试验/NCT05631860
NCT05631860已完成不适用

Are Neuroticism, Perceived Stress, and Adverse Life Events Risk Factors for Functional Somatic Disorders: DanFunD

University of Aarhus0 个研究点目标入组 7,493 人开始时间: 2011年11月10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
7,493
主要终点
Irritable bowel at 5-year follow-up

研究概览

简要总结

The objective of this study is to explore the role of neuroticism, perceived stress, and adverse life events, respectively, in the development and perpetuation of functional somatic disorders.

详细描述

Functional somatic disorders (FSD) are common disorders with a multifactorial aetiology involving biological, social, and psychological factors. An often used explanation of the illness mechanisms behind FSD which is provided to the patients is, that FSD may be understood as a multi systemic physical response to stress. This relationship can be modelled as proposed in the Cognitive Behavioural Therapy (CBT) model of emotional distress where several cognitive, behavioural and psychological factors are thought to contribute to the onset and perpetuation of FSD. Personality traits e.g. neuroticism contribute to give rise to our cognitive, behavioural, and psychological reactions. Furthermore, neuroticism with its heightened reactivity to stressors, has shown to be an important predictor of a generic vulnerability to both physical and psychological conditions. Having been exposed to previous adverse life events/traumas and childhood adversities has also showed to impact the risk of having FSD. This relationship has been proposed to be induced by a heightened response to stimuli, i.e. sensitisation, caused by physical and emotional distress triggering a hormonal cascade in the hypothalamus pituitary adrenal (HPA) axis.

So far, most studies into these aspects have been carried out in selected patient samples, and general population-based studies including a large randomly obtained sample are sparse. In three recent population-based studies, strong associations between FSD and neuroticism, perceived stress, and the accumulated number of experienced adverse life events (ALE), respectively, have been established. However, these studies were cross-sectional, thereby not providing insight to whether these factors were risk factors of FSD. More studies are needed for further elucidation on these aspects.

Objective The objective of this study is to explore the role of neuroticism, perceived stress, and the accumulated number of ALE, respectively, in the development and perpetuation of FSD.

Hypotheses

  1. Higher neuroticism, higher perceived stress, and higher number of ALE at baseline are individual risk factors of having developed FSD in the 5-year period from baseline to follow-up:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Not born in Denmark
  • Not being a Danish citizen
  • Pregnancy

结局指标

主要结局

Irritable bowel at 5-year follow-up

时间窗: At the DanFunD 5-year follow-up investigation

Participants fulfilling the diagnostic criteria for irritable bowel will be identified with self-reported questionnaires

Irritable bowel at baseline

时间窗: At the DanFunD baseline investigation

Participants fulfilling the diagnostic criteria for irritable bowel will be identified with self-reported questionnaires

Questionnaire-defined Functional somatic disorder at baseline

时间窗: At the DanFunD baseline investigation

Participants fulfilling the diagnostic criteria of the unifying diagnostic concept Bodily Distress Syndrome single- and multi-organ type will be defined with self-reported questionnaires.

Questionnaire-defined Functional somatic disorder at 5-year follow-up

时间窗: At the DanFunD 5-year follow-up investigation

Participants fulfilling the diagnostic criteria of the unifying diagnostic concept Bodily Distress Syndrome single- and multi-organ type will be defined with self-reported questionnaires.

Interview-based Functional somatic disorder at 5-year follow-up

时间窗: At the DanFunD 5-year follow-up investigation

Participants fulfilling the diagnostic criteria of the unifying diagnostic concept Bodily Distress Syndrome single- and multi-organ type will be defined with diagnostic interviews.

Chronic widespread pain at baseline

时间窗: At the DanFunD baseline investigation

Participants fulfilling the diagnostic criteria for chronic widespread pain will be identified with self-reported questionnaires

Chronic fatigue at baseline

时间窗: At the DanFunD baseline investigation

Participants fulfilling the diagnostic criteria for chronic fatigue will be identified with self-reported questionnaires.

Interview-based Functional somatic disorder at baseline

时间窗: At the DanFunD baseline investigation

Participants fulfilling the diagnostic criteria of the unifying diagnostic concept Bodily Distress Syndrome single- and multi-organ type will be defined with diagnostic interviews.

Chronic widespread pain at 5-year follow-up

时间窗: At the DanFunD 5-year follow-up investigation

Participants fulfilling the diagnostic criteria for chronic widespread pain will be identified with self-reported questionnaires.

Chronic fatigue at 5-year follow-up

时间窗: At the DanFunD 5-year follow-up investigation

Participants fulfilling the diagnostic criteria for chronic fatigue will be identified with self-reported questionnaires.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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