Welfare Benefits in Functional Somatic Disorders

NCT ID: NCT05611606

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9656 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-10
• Study Completion Date: 2015-08-30

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. healthy individuals, and

2. individuals with severe physical disease.

Detailed Description

Functional somatic disorders (FSD) are common conditions characterized by persistent patterns of physical symptoms that cannot be better explained by other physical or mental conditions (1). The conditions may cause severe impairment for the patients who present with reduced physical and mental health, lower social status, and poor labour market association (2-4).

In 2005, it was estimated that FSD accounted for 3% of hospitalizations and 10-20% of health care expenses in Denmark (5), and a newer Danish primary care study has shown patients with FSD to have higher annual health care costs compared with conventionally-defined conditions (6). In other countries, studies in clinical samples have shown increased direct and indirect health care costs of FSD (7, 8) showing a dose-response relationship with severity of the FSD (9). These studies into highly selected clinical samples may induce high risk of selection bias, and studies including random selected general population samples are therefore needed. One Canadian population-based study on health care costs of children, adolescents, and young adults with FSD also found increased health care use and costs for this group (10). Studies investigating the socioeconomic burden in terms of welfare benefits of FSD in an adult random sample from the general population are, however, lacking.

Objective To estimate the number of weeks of welfare benefits, i.e. sickness benefit, unemployment benefit and social assistance, for individuals with FSD and compare them to individuals without FSD and individuals with severe physical disease.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• None

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Clinical Research and Prevention

NETWORK

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Fink, DMSc

Role: STUDY_CHAIR

Aarhus University Hospital

References

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.

Reference Type: DERIVED

PMID: 40037070 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DanFunD welfare benefits

Identifier Type: -

Identifier Source: org_study_id