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

NCT ID: NCT04667611

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-09

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Keywords

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bodily stress syndrome functional somatic symptoms functional somatic syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mild

Psychosocial interventions

Intervention Type BEHAVIORAL

Cognitive behavioural therapy (CBT) based individual and group intervention

Moderate

Psychosocial interventions

Intervention Type BEHAVIORAL

Cognitive behavioural therapy (CBT) based individual and group intervention

Severe

Psychosocial interventions

Intervention Type BEHAVIORAL

Cognitive behavioural therapy (CBT) based individual and group intervention

Interventions

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Psychosocial interventions

Cognitive behavioural therapy (CBT) based individual and group intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Helena Liira

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helena Liira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Clinic for Functional Disorders, Helsinki University Hospital

Helsinki, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Helena Liira, MD, PhD

Role: CONTACT

Phone: +358505771351

Email: [email protected]

Jari Arokoski, MD, PhD

Role: CONTACT

Phone: +358504287901

Email: [email protected]

Facility Contacts

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Helena Liira, MD, PhD

Role: primary

Other Identifiers

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1159007

Identifier Type: -

Identifier Source: org_study_id