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Patient-reported Outcome Measures (PROMs) in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study

Patient-reported Outcome Measures (PROMs) as Characteristics and Prognostic Factors in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04667611
Acronym
SYMPA
Enrollment
400
Registered
2020-12-16
Start date
2020-03-09
Completion date
2023-12-31
Last updated
2020-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Syndrome, Dysphagia, Exhaustion; Syndrome, Fatigue, Fibromyalgia, Irritable Bowel Syndrome, Somatic Symptom

Keywords

bodily stress syndrome, functional somatic symptoms, functional somatic syndrome

Brief summary

This cohort study implements patient reported outcome measures (PROMs) for patients with bodily stress syndrome in a clinic for functional disorders.

Detailed description

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.

Interventions

BEHAVIORALPsychosocial interventions

Cognitive behavioural therapy (CBT) based individual and group intervention

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* All genders * Age 18-80 years * Referred to Clinic for Functional Disorders either from other hospital units or from primary care * Willingness to be enrolled in the study, by signing the informed consent

Exclusion criteria

* Patients not able to fill in the forms in Finnish or due to physical constraints (e.g. dystonia) * Symptoms are likely due to a somatic disorder

Design outcomes

Primary

MeasureTime frameDescription
Self-rated global health improvement12 monthsMeasured by clinical improvement scale (clinical global improvement, CGI), a five-point Likert scale
Functional ability12 monthsMeasured by WHODAS 2.0

Secondary

MeasureTime frameDescription
EUROHIS-QOL-83, 6 and 12 monthsHealth related quality of life
15D3, 6 and 12 monthsHealth related quality of life
PHQ-93, 6 and 12 monthsDepression
RS-143, 6 and 12 monthsResilience
SSD-123, 6 and 12 monthsSymptom severity
GAD-73, 6 and 12 monthsAnxiety

Countries

Finland

Contacts

Primary ContactHelena Liira, MD, PhD
helena.liira@hus.fi+358505771351
Backup ContactJari Arokoski, MD, PhD
jari.arokoski@hus.fi+358504287901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026