FibromyalgiaSYMPANCT04667611
Patient-reported Outcome Measures (PROMs) in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study
An observational study of Fibromyalgia and Irritable Bowel Syndrome, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
This cohort study implements patient reported outcome measures (PROMs) for patients with bodily stress syndrome in a clinic for functional disorders. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Irritable Bowel Syndrome, Somatic Symptom
- What is being tested?
- Psychosocial interventions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteFinland
- Study dates
- 9 Mar 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Clinic for Functional Disorders, Helsinki University Hospital
Helsinki, 00009
Helena Liira, MD, PhD, +358 50 5771351, helena.liira@hus.fi
About this study
Official title: Patient-reported Outcome Measures (PROMs) as Characteristics and Prognostic Factors in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study
This cohort study implements patient reported outcome measures (PROMs) for patients with bodily stress syndrome in a clinic for functional disorders.
Read the 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.
- Conditions
- Fibromyalgia, Irritable Bowel Syndrome, Somatic Symptom, Chronic Fatigue Syndrome, Fatigue, Dysphagia
- Being tested
- Psychosocial interventions
- Keywords
- bodily stress syndrome, functional somatic symptoms, functional somatic syndrome
- Medical subject headings
- Fibromyalgia, Irritable Bowel Syndrome, Medically Unexplained Symptoms, Fatigue Syndrome, Chronic, Fatigue, Deglutition Disorders, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial interventionsBehavioural
Cognitive behavioural therapy (CBT) based individual and group intervention
| Study group | Role | What they receive |
|---|---|---|
| Mild | Not described Receives: Behavioral: Psychosocial interventions | |
| Moderate | Not described Receives: Behavioral: Psychosocial interventions | |
| Severe | Not described Receives: Behavioral: Psychosocial interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-rated global health improvement
Measured by clinical improvement scale (clinical global improvement, CGI), a five-point Likert scale
Measured: 12 months
Functional ability
Measured by WHODAS 2.0
Measured: 12 months
Secondary outcomes (6)
PHQ-9
Depression
Measured: 3, 6 and 12 months
GAD-7
Anxiety
Measured: 3, 6 and 12 months
EUROHIS-QOL-8
Health related quality of life
Measured: 3, 6 and 12 months
15D
Health related quality of life
Measured: 3, 6 and 12 months
SSD-12
Symptom severity
Measured: 3, 6 and 12 months
RS-14
Resilience
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start9 Mar 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Liira, Helsinki University Central Hospital
- Investigators
- Helena Liira, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667611
- Sponsor's protocol ID
- 1159007
- Acronym
- SYMPA
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcome Measures (PROMs) as Characteristics and Prognostic Factors in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04667611
- Acronym / sponsor ID
- SYMPA / 1159007
- Conditions
- Fibromyalgia, Irritable Bowel Syndrome, Somatic Symptom, Chronic Fatigue Syndrome, Fatigue, Dysphagia
- Keywords
- bodily stress syndrome, functional somatic symptoms, functional somatic syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cohort study implements patient reported outcome measures (PROMs) for patients with bodily stress syndrome in a clinic for functional disorders.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild | – | Behavioral: Psychosocial interventions |
| Moderate | – | Behavioral: Psychosocial interventions |
| Severe | – | Behavioral: Psychosocial interventions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial interventionsCognitive behavioural therapy (CBT) based individual and group intervention | Behavioural | Mild, Moderate, Severe |
Primary outcome
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
6 secondary outcomes
PHQ-9
Time frame: 3, 6 and 12 months
GAD-7
Time frame: 3, 6 and 12 months
EUROHIS-QOL-8
Time frame: 3, 6 and 12 months
15D
Time frame: 3, 6 and 12 months
SSD-12
Time frame: 3, 6 and 12 months
RS-14
Time frame: 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Liira, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Irritable Bowel Syndrome, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helena Liira, MD, PhD (+358505771351, helena.liira@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-rated global health improvement (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.