NCT05611606

Brief Summary

The objective of this observational study is to estimate the number of weeks of welfare benefits, i.e. sickness benefit, unemployment benefit and social assistance, for individuals with functional somatic disorders and compare them to

  1. 1.healthy individuals, and
  2. 2.individuals with severe physical disease.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,656

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2015

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
Last Updated

December 5, 2022

Status Verified

October 1, 2022

Enrollment Period

3.6 years

First QC Date

November 3, 2022

Last Update Submit

December 1, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Sickness benefit

    Wellfare benefit disbursed to employed citizens being ill, unemployed citizens currently ill, citizens in activation programs currently ill, and citizens in flexible jobs but currently ill

    10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation

  • Unemployment benefit

    Welfare benefit disbursed to unemployed citizens who receive unemployment benefit (full or part time, during vacation or activation) together with citizens on social assistance who are deemed ready-to-work, only receiving social assistance because of unemployment, but having no entitlement to unemployment benefit.

    10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation

  • Social assistance

    A welfare payment administered by the municipal social service department and is allocated if citizens are unable to support themselves.

    10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation

Secondary Outcomes (4)

  • No transfer income/self-support

    10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation

  • Public retirement pension

    10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation

  • Emigration

    10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation

  • Death

    10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation

Study Arms (1)

DanFunD baseline

Data from the DanFunD baseline cohort will be included (11). It comprises a total of 9,656 (33.7% of the invited participants) men and women aged 18-76 years born in Denmark and living in the Western part of greater Copenhagen. Individuals with FSD are identified by means of self-reported questionnaires (n=9,656) (2) and diagnostic research interviews (n=1,590) (12). Participants with FSD will be defined as follows: * FSD operationalised by the Bodily Distress Syndrome single- and multi-organ type will be defined with both self-reported questionnaires (14) and diagnostic interviews (3) * Three functional somatic syndromes, i.e. irritable bowel (15), chronic widespread pain (16), and chronic fatigue (17) will be defined with questionnaires. Severe physical disease will be defined as having received at least one of the following five diagnoses: Cancer, stroke, myocardial infarction, other heart disease, and obstructive pulmonary disease.

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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. All participants filled in questionnaires regarding physical symptoms and psychological factors, among others. A stratified subsample (n=2,450) of every tenth participant and every symptom high score participant on the DanFunD baseline symptom questionnaires were invited to participate in a diagnostic interview, the Research Interview for Functional somatic Disorders (RIFD), performed by trained family physicians (28); 1,590 (64.9%) accepted and participated in the interview.

You may qualify if:

  • None

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Petersen MW, Wellnitz KB, Carstensen TBW, Dantoft TM, Ornbol E, Bjerregaard AA, Jorgensen T, Fink P. Welfare benefit utilization for people with functional somatic disorder. A population-based cohort study. J Psychosom Res. 2025 Apr;191:112073. doi: 10.1016/j.jpsychores.2025.112073. Epub 2025 Feb 27.

MeSH Terms

Conditions

FibromyalgiaIrritable Bowel SyndromeFatigue Syndrome, ChronicSomatoform DisordersMedically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesEncephalomyelitisNeuroinflammatory DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersSigns and Symptoms

Study Officials

  • Per Fink, DMSc

    Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 10, 2022

Study Start

November 10, 2011

Primary Completion

June 30, 2015

Study Completion

August 30, 2015

Last Updated

December 5, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share