FibromyalgiaNCT05611606
Welfare Benefits in Functional Somatic Disorders
An observational study of Fibromyalgia and Irritable Bowel Syndrome, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome
- How many people
- 9,656 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2011to 30 Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- None
Who cannot join
- Not born in Denmark
- Not being a Danish citizen
- Pregnancy
About this study
Official title: Welfare Benefits for Individuals With Functional Somatic Disorders: DanFunD
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
- healthy individuals, and
- individuals with severe physical disease.
Read the 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
- Medical subject headings
- Fibromyalgia, Irritable Bowel Syndrome, Fatigue Syndrome, Chronic, Somatoform Disorders, Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Individuals that do not receive welfare payments under the circumstances of sickness, unemployment, or social benefits. Including leave-of-absence schemes and grants from State Education Fund.
Measured: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Public retirement pension
Public retirement pension
Measured: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Emigration
Participant not resident in Denmark
Measured: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Death
Participant dead
Measured: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start10 Nov 2011
- Primary completion30 Jun 2015
- Study completion30 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 9,656 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Clinical Research and Prevention
- Responsible party
- Sponsor
- Investigators
- Per Fink, DMSc, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611606
- Sponsor's protocol ID
- DanFunD welfare benefits
- Status last verified
- Oct 2022
- First submitted
- 3 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40037070
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Welfare Benefits for Individuals With Functional Somatic Disorders: DanFunD
- ClinicalTrials.gov ID
- NCT05611606
- Acronym / sponsor ID
- DanFunD welfare benefits
- Conditions
- Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome, Bodily Distress Syndrome, Somatoform Disorders, Medically Unexplained Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,656 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Center for Clinical Research and Prevention
- Study start
- 10 Nov 2011 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Aug 2015 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- healthy individuals, and
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- None
Key exclusion criteria (3 listed)
- Not born in Denmark
- Not being a Danish citizen
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sickness benefit
Time frame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
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
Unemployment benefit
Time frame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
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.
Social assistance
Time frame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
A welfare payment administered by the municipal social service department and is allocated if citizens are unable to support themselves.
4 secondary outcomes
No transfer income/self-support
Time frame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Public retirement pension
Time frame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Emigration
Time frame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Death
Time frame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Derived from this study: PubMed 40037070Petersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Fink, DMSc study chair
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Irritable Bowel Syndrome, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sickness benefit (time frame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.