Psychological Risk Factors for Functional Somatic Disorders

NCT05631860 | Completed

• 1 other identifier: DanFunD psychol. risk factors
• Study Type: observational
• Target: 7,493
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Irritable Bowel Syndrome; Fibromyalgia; Chronic Fatigue Syndrome; Somatoform Disorders; Bodily Distress Syndrome; Medically Unexplained Symptoms; Medically Unexplained Syndrome

Outcome Measures

Primary Outcomes (10)

• Questionnaire-defined Functional somatic disorder at baseline

  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.

  At the DanFunD baseline investigation

• Interview-based Functional somatic disorder at baseline

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

  At the DanFunD baseline investigation

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

  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.

  At the DanFunD 5-year follow-up investigation

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

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

  At the DanFunD 5-year follow-up investigation

• Irritable bowel at baseline

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

  At the DanFunD baseline investigation

• Irritable bowel at 5-year follow-up

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

  At the DanFunD 5-year follow-up investigation

• Chronic widespread pain at baseline

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

  At the DanFunD baseline investigation

• Chronic widespread pain at 5-year follow-up

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

  At the DanFunD 5-year follow-up investigation

• Chronic fatigue at baseline

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

  At the DanFunD baseline investigation

• Chronic fatigue at 5-year follow-up

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

  At the DanFunD 5-year follow-up investigation

Other Outcomes (3)

• Neuroticism score at baseline

  Measured at baseline

• Perceived Stress score at baseline

  Measured at baseline

• The accumulated number of adverse life events score at baseline

  Measured at baseline

Study Arms (2)

DanFunD baseline

The baseline cohort (gathered in the years 2012-2015) is a random sample selected through the National Civil Registration system among people living in 10 municipalities in the western part of greater Copenhagen, Denmark, ages 18 to 76 years. The baseline cohort constitutes data from self-reported questionnaires (n=7,493) and diagnostic interviews data (n=1,590).

DanFunD 5-years follow-up investigation

The follow-up cohort (gathered in the years 2018-2020) consists of participants all born in Denmark, between 24 and 84 years of age. The follow-up cohort constitutes data from self-reported questionnaires (n=4,288) and diagnostic interviews data (n=1,094).

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 28773 participants were randomly drawn from the adult general Danish population by means of the the Danish Civil Registration system. The DanFunD baseline cohort comprises a total of 9,656 (33.7% of invited participants) men and women aged 18-76 years, born in Denmark, and living in the Western part of greater Copenhagen. The follow-up cohort (gathered in the years 2018-2020) consists of participants all born in Denmark, between 24 and 84 years of age. The follow-up cohort constitutes data from self-reported questionnaires (n=4,288) and diagnostic interviews data (n=1,094).

You may qualify if:

• \- None

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Center for Clinical Research and Prevention: collaborator

MeSH Terms

Conditions

Irritable Bowel Syndrome; Fibromyalgia; Fatigue Syndrome, Chronic; Somatoform Disorders; Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Signs and Symptoms

Study Officials

• Per Fink, DMSc

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 30, 2022
• Study Start: November 10, 2011
• Primary Completion: January 4, 2021
• Study Completion: August 30, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share