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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Behavioral: Psychosocial interventions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild<br> | Behavioral: Psychosocial interventions<br>* Cognitive behavioural therapy (CBT) based individual and group intervention<br>|
| Moderate<br> | Behavioral: Psychosocial interventions<br>* Cognitive behavioural therapy (CBT) based individual and group intervention<br>|
| Severe<br> | Behavioral: Psychosocial interventions<br>* Cognitive behavioural therapy (CBT) based individual and group intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ-9 | Depression | 3, 6 and 12 months | 
| GAD-7 | Anxiety | 3, 6 and 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bodily stress syndrome, functional somatic symptoms, functional somatic syndrome