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

NCT04667611 | Unknown

• 1 other identifier: 1159007
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

bodily stress syndrome; functional somatic symptoms; functional somatic syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• PHQ-9

  3, 6 and 12 months

• GAD-7

  3, 6 and 12 months

• EUROHIS-QOL-8

  3, 6 and 12 months

• 15D

  3, 6 and 12 months

• SSD-12

  3, 6 and 12 months

Study Arms (3)

Mild

Behavioral: Psychosocial interventions

Moderate

Behavioral: Psychosocial interventions

Severe

Behavioral: Psychosocial interventions

Interventions

Psychosocial interventions BEHAVIORAL

Cognitive behavioural therapy (CBT) based individual and group intervention

Mild; Moderate; Severe

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Clinic for Functional Disorders, Helsinki University Hospital

Helsinki, 00009, Finland

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Irritable Bowel Syndrome; Medically Unexplained Symptoms; Fatigue Syndrome, Chronic; Fatigue; Deglutition Disorders; Syndrome

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Encephalomyelitis; Neuroinflammatory Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Esophageal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Disease

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Helena Liira, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Liira, MD, PhD

CONTACT

+358505771351; helena.liira@hus.fi

Jari Arokoski, MD, PhD

CONTACT

+358504287901; jari.arokoski@hus.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: March 9, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)