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

• ClinicalTrials.gov Identifier: NCT04667611
• Recruitment Status: Recruiting
• First Posted: December 16, 2020
• Last Update Posted: December 16, 2020
• Sponsor: Helsinki University Central Hospital
• Information provided by (Responsible Party): Helena Liira, Helsinki University Central Hospital

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
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
• Estimated 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: March 9, 2020
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2023

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Self-rated global health improvement [ Time Frame: 12 months ]
   Measured by clinical improvement scale (clinical global improvement, CGI), a five-point Likert scale
2. Functional ability [ Time Frame: 12 months ]
   Measured by WHODAS 2.0

Secondary Outcome Measures :

1. PHQ-9 [ Time Frame: 3, 6 and 12 months ]
   Depression
2. GAD-7 [ Time Frame: 3, 6 and 12 months ]
   Anxiety
3. EUROHIS-QOL-8 [ Time Frame: 3, 6 and 12 months ]
   Health related quality of life
4. 15D [ Time Frame: 3, 6 and 12 months ]
   Health related quality of life
5. SSD-12 [ Time Frame: 3, 6 and 12 months ]
   Symptom severity
6. RS-14 [ Time Frame: 3, 6 and 12 months ]
   Resilience

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

Criteria

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

Contacts and Locations

Contacts

Contact: Helena Liira, MD, PhD; +358505771351; helena.liira@hus.fi

Contact: Jari Arokoski, MD, PhD; +358504287901; jari.arokoski@hus.fi

Locations

Finland

Clinic for Functional Disorders, Helsinki University Hospital; Recruiting

Helsinki, Finland, 00009

Contact: Helena Liira, MD, PhD +358 50 5771351 helena.liira@hus.fi

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators

• Principal Investigator: Helena Liira, MD, PhD; Helsinki University Central Hospital

More Information

• Responsible Party: Helena Liira, Chief Physician, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT04667611
• Other Study ID Numbers: 1159007
• First Posted: December 16, 2020
• Last Update Posted: December 16, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helena Liira, Helsinki University Central Hospital:

bodily stress syndrome; functional somatic symptoms; functional somatic syndrome

Additional relevant MeSH terms:

Fatigue Syndrome, Chronic; Fibromyalgia; Irritable Bowel Syndrome; Syndrome; Fatigue; Medically Unexplained Symptoms; Disease; Pathologic Processes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Virus Diseases; Infections; Encephalomyelitis; Central Nervous System Diseases