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

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04667611

Collaborator

(none)

400

Enrollment

Location

44.7

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Irritable Bowel Syndrome Somatic Symptom Chronic Fatigue Syndrome Fatigue Dysphagia Exhaustion; Syndrome	Behavioral: Psychosocial interventions

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 Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 9, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Mild	Behavioral: Psychosocial interventions Cognitive behavioural therapy (CBT) based individual and group intervention
Moderate	Behavioral: Psychosocial interventions Cognitive behavioural therapy (CBT) based individual and group intervention
Severe	Behavioral: Psychosocial interventions Cognitive behavioural therapy (CBT) based individual and group intervention

Arm

Intervention/Treatment

Mild

Behavioral: Psychosocial interventions

Cognitive behavioural therapy (CBT) based individual and group intervention

Moderate

Behavioral: Psychosocial interventions

Cognitive behavioural therapy (CBT) based individual and group intervention

Severe

Behavioral: Psychosocial interventions

Cognitive behavioural therapy (CBT) based individual and group intervention

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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