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

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

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.

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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

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04667611


Contacts
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Contact: Helena Liira, MD, PhD +358505771351 helena.liira@hus.fi
Contact: Jari Arokoski, MD, PhD +358504287901 jari.arokoski@hus.fi

Locations
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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
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Principal Investigator: Helena Liira, MD, PhD Helsinki University Central Hospital
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Responsible Party: Helena Liira, Chief Physician, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04667611    
Other Study ID Numbers: 1159007
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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
Encephalomyelitis
Central Nervous System Diseases