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

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

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

Study Overview

• Status: Recruiting
• Conditions: Fatigue; Irritable Bowel Syndrome; Fibromyalgia; Dysphagia; Chronic Fatigue Syndrome; Somatic Symptom; Exhaustion; Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Helena Liira, MD, PhD; Phone Number: +358505771351; Email: helena.liira@hus.fi
• Study Contact Backup: Name: Jari Arokoski, MD, PhD; Phone Number: +358504287901; Email: jari.arokoski@hus.fi

Study Locations

• Finland
  • Helsinki, Finland, 00009
    • Recruiting
    • Clinic for Functional Disorders, Helsinki University Hospital
    • Contact: Helena Liira, MD, PhD; Phone Number: +358 50 5771351; Email: helena.liira@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of consecutive patients referred to the Clinic for Functional Disorders and who give their consent to be followed up during one year after their visit to the clinic.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2020
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (ACTUAL): December 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: bodily stress syndrome; functional somatic symptoms; functional somatic syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Gastrointestinal Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Encephalomyelitis; Syndrome; Fatigue; Irritable Bowel Syndrome; Fibromyalgia; Fatigue Syndrome, Chronic; Medically Unexplained Symptoms
• Other Study ID Numbers: 1159007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No