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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04667611
Other study ID # 1159007
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 9, 2020
Est. completion date December 2023

Study information

Verified date December 2020
Source Helsinki University Central Hospital
Contact Helena Liira, MD, PhD
Phone +358505771351
Email helena.liira@hus.fi
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2023
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Psychosocial interventions
Cognitive behavioural therapy (CBT) based individual and group intervention

Locations

Country Name City State
Finland Clinic for Functional Disorders, Helsinki University Hospital Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-rated global health improvement Measured by clinical improvement scale (clinical global improvement, CGI), a five-point Likert scale 12 months
Primary Functional ability Measured by WHODAS 2.0 12 months
Secondary PHQ-9 Depression 3, 6 and 12 months
Secondary GAD-7 Anxiety 3, 6 and 12 months
Secondary EUROHIS-QOL-8 Health related quality of life 3, 6 and 12 months
Secondary 15D Health related quality of life 3, 6 and 12 months
Secondary SSD-12 Symptom severity 3, 6 and 12 months
Secondary RS-14 Resilience 3, 6 and 12 months
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