An observational study in Fibromyalgia, Irritable Bowel Syndrome and Somatic Symptom, sponsored by Helsinki University Central Hospital. Status unknown at 1 site in Finland. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-16.
Sponsored by Helsinki University Central Hospital · Observational
This cohort study implements patient reported outcome measures (PROMs) for patients with bodily stress syndrome in a clinic for functional disorders.
The Sympa Cohort study is a prospective, single site cohort study that consists of administration of PROMs questionnaires to patients that attend the Clinic for Functional Disorders at Helsinki University hospital (HUS). The questionnaires are handed out to the study population within seven days before their first visit at the clinic, and then at the following 3, 6 and 12 months. The study population consists of consecutive adult patients that are referred to the clinic either from other hospital units or primary care. The collected data will later be linked with national registries on diagnoses, medication use and work ability. The Sympa Cohort study may have implications in targeting the factors influencing functional outcomes and quality of life reported by patients with bodily stress syndrome. It will also form a quality register for the Clinic and characterize the first systematic collection of PROMs related to these disorders in Finland.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 400 is above the median of 100 across 279 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of consecutive patients referred to the Clinic for Functional Disorders and who give their consent to be followed up during one year after their visit to the clinic.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Psychosocial interventions
Behavioral: Psychosocial interventions
Behavioral: Psychosocial interventions
Cognitive behavioural therapy (CBT) based individual and group intervention
Self-rated global health improvement
Measured by clinical improvement scale (clinical global improvement, CGI), a five-point Likert scale
Time frame: 12 months
Functional ability
Measured by WHODAS 2.0
Time frame: 12 months
PHQ-9
Depression
Time frame: 3, 6 and 12 months
GAD-7
Anxiety
Time frame: 3, 6 and 12 months
EUROHIS-QOL-8
Health related quality of life
Time frame: 3, 6 and 12 months
15D
Health related quality of life
Time frame: 3, 6 and 12 months
SSD-12
Symptom severity
Time frame: 3, 6 and 12 months
RS-14
Resilience
Time frame: 3, 6 and 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2020 (actual). Primary completion is estimated for Dec 2022, 33 months after the start.
Of 81 non-industry observational studies under Fibromyalgia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 109. This study's planned 33 months is above that.
Counting every sponsor, half of 88 studies reached it within 27 months; a quarter within 8 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital →