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

• Conditions: Chronic Fatigue Syndrome; Fatigue; Exhaustion; Syndrome; Fibromyalgia; Irritable Bowel Syndrome; Dysphagia; Somatic Symptom
• Interventions: Behavioral: Psychosocial interventions

• Registration Number: NCT04667611
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2020-03-09
• Status Verified: 2020-12
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-08
• Last Update Submitted: 2020-12-08
• Study First Posted: 2020-12-16
• Last Update Posted: 2020-12-16
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild	Psychosocial interventions	-
Severe	Psychosocial interventions	-
Moderate	Psychosocial interventions	-

Primary Outcome Measures

Name	Time	Method
Self-rated global health improvement	12 months	Measured by clinical improvement scale (clinical global improvement, CGI), a five-point Likert scale
Functional ability	12 months	Measured by WHODAS 2.0

Secondary Outcome Measures

Name	Time	Method
RS-14	3, 6 and 12 months	Resilience
EUROHIS-QOL-8	3, 6 and 12 months	Health related quality of life
PHQ-9	3, 6 and 12 months	Depression
GAD-7	3, 6 and 12 months	Anxiety
15D	3, 6 and 12 months	Health related quality of life
SSD-12	3, 6 and 12 months	Symptom severity

Trial Locations

Locations (1)

Clinic for Functional Disorders, Helsinki University Hospital; 🇫🇮 Helsinki, Finland