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临床试验/NCT06006715
NCT06006715已完成不适用

Psychiatric Disorders as Risk Factor for Functional Somatic Disorders. DanFunD - a Population-based Study

Aarhus University Hospital0 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
发起方
入组人数
7,493
主要终点
Questionnaire-defined Functional somatic disorder at 5-year follow-up

研究概览

简要总结

The objectives of this study are: Firstly, to investigate the association between psychiatric disorders and functional somatic disorder (FSD). Secondly, to investigate whether psychiatric disorders are risk factors for newly developed (incident) FSD after a 5-year follow-up period.

详细描述

Functional somatic disorder (FSD) is a common condition characterized by a persistent pattern of impairing physical symptoms. Our knowledge about what causes the development and perpetuating of these disorders is still sparse, however, it is well accepted that they have a multifactorial aetiology, comprising both biological, psychological, and social factors.

The relationship between FSD and other conditions have been investigated in different manners: A study in patients with severe FSD have shown an increased number of other physical diagnoses compared to healthy controls. A general population-based study has shown FSD to be associated with other self-reported physical diseases, depression, and anxiety. Further, psychopathology has shown to predict irritable bowel syndrome and fibromyalgia, while irritable bowel syndrome has shown to predict common mental disorders (5). However, for some diagnoses, e.g. whiplash associated disorders, the relationship with psychiatric disorders is more inconsistent.

The previous research may carry some limitations: Clinical studies into highly selected patient samples may carry risk of selection bias, and most population-based studies have used self-report for establishing FSD diagnoses and psychiatric diagnoses which may bring risk of misclassification. Hence, more studies with a sound methodology into these aspects are needed.

The proposed longitudinal study includes data from two investigations of the same cohort from the general Danish population. Both validated symptom questionnaires and diagnostic interviews will be used for the establishment of FSD diagnoses and psychiatric discharge diagnoses and prescription medication will be obtained from the comprehensive Danish Central Registries.

Objective

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

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

时间窗: Time Frame: 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.

Irritable bowel at baseline

时间窗: Time Frame: 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.

Interview-based Functional somatic disorder at baseline

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

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

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

时间窗: Time Frame: 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.

Irritable bowel at 5-year follow-up

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

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

Chronic fatigue at 5-year follow-up

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

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

Chronic widespread pain at baseline

时间窗: Time Frame: 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: Time Frame: At the DanFunD baseline 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

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Sponsor

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