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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild |
| ||
| Moderate |
| ||
| Severe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial interventions | Behavioral | Cognitive behavioural therapy (CBT) based individual and group intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-rated global health improvement | Measured by clinical improvement scale (clinical global improvement, CGI), a five-point Likert scale | 12 months |
| Functional ability | Measured by WHODAS 2.0 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PHQ-9 | Depression | 3, 6 and 12 months |
| GAD-7 | Anxiety | 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helena Liira, MD, PhD | Contact | +358505771351 | helena.liira@hus.fi | |
| Jari Arokoski, MD, PhD | Contact | +358504287901 | jari.arokoski@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Helena Liira, MD, PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Functional Disorders, Helsinki University Hospital | Recruiting | Helsinki | 00009 | Finland |
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| EUROHIS-QOL-8 |
Health related quality of life |
| 3, 6 and 12 months |
| 15D | Health related quality of life | 3, 6 and 12 months |
| SSD-12 | Symptom severity | 3, 6 and 12 months |
| RS-14 | Resilience | 3, 6 and 12 months |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D043183 | Irritable Bowel Syndrome |
| D000071896 | Medically Unexplained Symptoms |
| D015673 | Fatigue Syndrome, Chronic |
| D005221 | Fatigue |
| D003680 | Deglutition Disorders |
| D013577 | Syndrome |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D004935 | Esophageal Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D004194 | Disease |
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| ID | Term |
|---|---|
| D000083626 | Psychosocial Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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