Psychiatric Disorders and Functional Somatic Disorders
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ClinicalTrials.gov Identifier: NCT06006715 |
Recruitment Status :
Completed
First Posted : August 23, 2023
Last Update Posted : September 8, 2023
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Condition or disease |
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Irritable Bowel Fibromyalgia Chronic Fatigue Syndrome Bodily Distress Syndrome Medically Unexplained Syndrome |
Study Type : | Observational |
Actual Enrollment : | 7493 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Psychiatric Disorders as Risk Factor for Functional Somatic Disorders. DanFunD - a Population-based Study |
Actual Study Start Date : | November 10, 2011 |
Actual Primary Completion Date : | January 4, 2021 |
Actual Study Completion Date : | August 30, 2022 |
Group/Cohort |
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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).
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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).
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- Questionnaire-defined Functional somatic disorder at baseline [ 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 self-reported questionnaires.
- Interview-based Functional somatic disorder at baseline [ Time Frame: 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.
- Questionnaire-defined Functional somatic disorder at 5-year follow-up [ Time Frame: 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.
- Interview-based Functional somatic disorder at 5-year follow-up [ Time Frame: 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 baseline [ Time Frame: Time Frame: At the DanFunD baseline investigation ]Participants fulfilling the diagnostic criteria for irritable bowel will be identified with self-reported questionnaires
- Irritable bowel at 5-year follow-up [ Time Frame: 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 widespread pain at baseline [ Time Frame: Time Frame: At the DanFunD baseline investigation ]Participants fulfilling the diagnostic criteria for chronic widespread pain will be identified with self-reported questionnaires
- Chronic widespread pain at 5-year follow-up [ Time Frame: 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.
- Chronic fatigue at baseline [ Time Frame: Time Frame: At the DanFunD baseline investigation ]Participants fulfilling the diagnostic criteria for chronic fatigue will be identified with self-reported questionnaires.
- Chronic fatigue at 5-year follow-up [ Time Frame: 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.
- Presence of psychiatric disorders (overall): Yes/no [ Time Frame: Time frame: Given within 10 years before the DanFunD baseline investigation. ]Defined as having at least one of the following psychiatric diagnoses: Alcohol and drug abuse, anxiety disorders, depression and bipolar disorders, developmental and behavioural disorders, eating disorders, schizophrenia spectrum disorders, and stress-related disorders.
- Presence of anxiety disorders: Yes/no [ Time Frame: Time frame: Given within 10 years before the DanFunD baseline investigation. ]Defined as having at least one of the ICD-10 codes F40, F41, and F42 or ATC-codes N06A.
- Presence of depression: Yes/no [ Time Frame: Time frame: Given within 10 years before the DanFunD baseline investigation. ]Defined as having at least one of the ICD-10 codes F32 and F33 or ATC-codes N06A and N05AN01.
- Presence of bipolar disorder: Yes/no [ Time Frame: Time frame: Given within 10 years before the DanFunD baseline investigation. ]Defined as having at least one of the ICD-10 codes F30 and F31 or ATC-codes N06A and N05AN01.
- Presence of personality disorder: Yes/no [ Time Frame: Time frame: Given within 10 years before the DanFunD baseline investigation. ]Defined with the ICD-10 code F6.
- Presence of stress-related disorders: Yes/no [ Time Frame: Time frame: Given within 10 years before the DanFunD baseline investigation. ]Defined with the ICD-10 code F43.
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Ages Eligible for Study: | 18 Years to 84 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
A total of 25,368 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 7,493 (29.5% 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).
Inclusion Criteria:
- None
Exclusion Criteria:
- Not born in Denmark
- Not being a Danish citizen
- Pregnancy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06006715
Study Chair: | Per Fink, DMSc | Aarhus University Hospital |
Responsible Party: | Aarhus University Hospital |
ClinicalTrials.gov Identifier: | NCT06006715 |
Other Study ID Numbers: |
DanFunD Psychiatric disorders |
First Posted: | August 23, 2023 Key Record Dates |
Last Update Posted: | September 8, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Restrictions apply to the availability of data according to Danish law, which means that data cannot be made publicly available. A request for collaboration or access to data can be sent to ckff@regionh.dk. An application for data should consist of a short synopsis of the study planned. Please see our website (www. danfund.org) for more information. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Fibromyalgia Fatigue Syndrome, Chronic Syndrome Mental Disorders Problem Behavior Somatoform Disorders Disease Pathologic Processes Muscular Diseases |
Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Behavioral Symptoms Encephalomyelitis Neuroinflammatory Diseases Chronic Disease Disease Attributes |