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
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Condition or disease | Intervention/treatment |
---|---|
Fibromyalgia Irritable Bowel Syndrome Somatic Symptom Chronic Fatigue Syndrome Fatigue Dysphagia Exhaustion; Syndrome | Behavioral: Psychosocial interventions |
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 |
- Self-rated global health improvement [ Time Frame: 12 months ]Measured by clinical improvement scale (clinical global improvement, CGI), a five-point Likert scale
- Functional ability [ Time Frame: 12 months ]Measured by WHODAS 2.0
- PHQ-9 [ Time Frame: 3, 6 and 12 months ]Depression
- GAD-7 [ Time Frame: 3, 6 and 12 months ]Anxiety
- EUROHIS-QOL-8 [ Time Frame: 3, 6 and 12 months ]Health related quality of life
- 15D [ Time Frame: 3, 6 and 12 months ]Health related quality of life
- SSD-12 [ Time Frame: 3, 6 and 12 months ]Symptom severity
- 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 |
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

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
Contact: Helena Liira, MD, PhD | +358505771351 | helena.liira@hus.fi | |
Contact: Jari Arokoski, MD, PhD | +358504287901 | jari.arokoski@hus.fi |
Finland | |
Clinic for Functional Disorders, Helsinki University Hospital | Recruiting |
Helsinki, Finland, 00009 | |
Contact: Helena Liira, MD, PhD +358 50 5771351 helena.liira@hus.fi |
Principal Investigator: | Helena Liira, MD, PhD | Helsinki University Central Hospital |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
bodily stress syndrome functional somatic symptoms functional somatic syndrome |
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 |