Familial Mediterranean Fever (FMF )NCT06830213
Investigation of the Validity, Reliability and Responsiveness of the BETY-BQ in FMF
An observational study of Familial Mediterranean Fever (FMF ), run by Aysima Barlak at 1 site in Turkey (Türkiye).
Trial summary
FMF is associated with many different clinical entities. The disease appears to be associated with many diseases and/or syndromes with common features of genetic predisposition, immune dysfunction and autoinflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Familial Mediterranean Fever (FMF )
- What is being tested?
- Questionnaire study
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2025to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of individuals who come to the university hospital for routine controls.
Who may be able to join
- Having a diagnosis of Familial Mediterranean Fever
- Being literate
- Being 18 years of age or older
- Having read and signed the informed consent
Who cannot join
- History of major psychiatric illness
- Malignant disease
- History of peripheral vascular disease or neuropathy
- Not volunteering for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Altındağ
Aysima Barlak, License, 05412311754, fztaysimabarlak@gmail.com
About this study
Official title: Investigation of the Validity, Reliability and Responsiveness of the BETY-Biopsychosocial Questionnaire in Familial Mediterranean Fever
FMF is associated with many different clinical entities. The disease appears to be associated with many diseases and/or syndromes with common features of genetic predisposition, immune dysfunction and autoinflammation. Pericardial inflammation, cardiovascular conditions such as ischaemic heart disease, other rheumatic diseases such as ankylosing spondylitis (AS), vasculitis, especially Behçet's disease, malignancy and infertility are often associated with FMF. Early detection of these associations makes it possible to improve the management and prognosis of patients with FMF.
The chronic nature of the disease, as in other chronic diseases, includes problems such as pain, fatigue, sleep problems, loss of function, anxiety, depression and social isolation. This complex structure is accompanied by a picture in which inflammatory processes are triggered.
Read more
When the literature is examined, it is emphasised that chronic diseases with multifaceted symptoms require evaluation and methods that include all these biopsychosocial features. On the other hand, although it is stated that the common goal of non-pharmacological treatments is to contribute to biopsychosocial improvement in the patient, it is emphasised that evaluations with biopsychosocial content are insufficient. This situation causes the need for scales that provide an assessment from a holistic perspective in chronic diseases.
Cognitive Exercise Therapy Approach (BETY) is an innovative exercise approach developed on the basis of biopsychosocial model on individuals with rheumatism. The parameters that constitute the innovation are detailed under four headings: function-oriented core stabilisation exercises, information management in pain, information management in mood, and information management in sexuality. This method has a unique scale that offers biopsychosocial assessment. The Cognitive Exercise Therapy Approach - Biopsychosocial Questionnaire (BETY-BQ) was created by receiving feedback from individuals with rheumatism who participated in BETY exercise training 3 days a week for many years, expressing the improvement characteristics they experienced by participating in exercise sessions. The BETY-BQ evaluates the individual biopsychosocially with six sub-headings: pain, functionality-fatigue, emotion-state, sociability, sexuality and sleep.
The validity, reliability and sensitivity of the BETY-BQ have been demonstrated in many rheumatic diseases such as rheumatoid arthritis, fibromyalgia, psoriatic arthritis, systemic lupus erythematosus, ankylosing spondylitis, knee osteoarthritis, primary Sjögren's syndrome. Currently, it is clear that there is a need for scales that offer biopsychosocial assessment for individuals diagnosed with rheumatism, where biopsychosocial approaches are recommended in EULAR recommendations. BETY-BQ is included in the EULAR library as a biopsychosocial status measurement tool. This study will investigate the validity, reliability and responsiveness of the BETY-BQ, a biopsychosocial assessment tool, in individuals diagnosed with Familial Mediterranean Fever.
- Conditions
- Familial Mediterranean Fever (FMF )
- Being tested
- Questionnaire study
- Keywords
- Familial Mediterranean Fever, biopsychosocial, depression, social isolation, pain, sleep, functionality
- Medical subject headings
- Familial Mediterranean Fever, Depression, Social Isolation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire studyOther
Questionnaire application
What is being measured
The primary outcome is the main question the study is designed to answer.
BETY-Biopsychosocial Questionnaire
The biopsychosocial status of the individual is assessed with questions about pain, functionality, mood, sociability, sexuality, and sleep status. Each question consists of 30 items scored between 0-120 as '0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), 4 (yes always)'. A high score indicates poor biopsychosocial status
Measured: 3 mounths
Secondary outcomes (5)
Hospital Anxiety Depression Scale
It consists of 14 items, 7 of which assess anxiety, and the other 7 determine depression. Each item is scored between 0-3, and the total is scored between 0-21. High scores indicate poor anxiety and depression levels.
Measured: 3 mounths
Health Assessment Questionnaire
The Health Assessment Questionnaire evaluates the functionality of the individual using eight parameters and 20 items. The parameters are classified as dressing, standing, eating, walking, hygiene, reaching, grasping, and other activities. Each item is scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with a lot of difficulty), and 3 (unable to do at all). The total score is between 0-3, with a high score indicating low functionality.
Measured: 3 mounths
Short Form - 36
The SF-36 is a patient-orientated assessment scale created in the United States of America that allows for general health screening. Each sub-parameter is scored between 0 and 100 points and a high score indicates good health status. The SF-36 scale has 8 sub-parameters including general health perception, physical function, social function, pain, mental health, role difficulties due to physical causes, role difficulties due to emotional causes and vitality and includes 11 questions with a total of 36 items.
Measured: 3 mounths
Pain Catastrophizing Scale
This scale, developed by Sullivan et al. serves to measure the extent to which individuals catastrophise pain and the exaggerated negative mental reaction they show to current or anticipated painful experience. The scale consists of 13 items. Each item is scored as never=0, slightly=1, moderately=2, greatly=3 and always=4. A high total score indicates a high degree of catastrophising of pain.
Measured: 3 mounths
Fatigue Severity Scale
It is a scale that evaluates fatigue and consists of 9 questions. Each item is scored between 0 and 7. The total score is divided by 9, and if the average is <4, no fatigue is assessed, and if ≥4, fatigue is assessed.
Measured: 3 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start18 Feb 2025 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean Fever (FMF )Studies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aysima Barlak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysima Barlak, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830213
- Sponsor's protocol ID
- SBA 24/1114
- Status last verified
- Dec 2024
- First submitted
- 11 Feb 2025
- Last updated
- 19 Feb 2025
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Validity, Reliability and Responsiveness of the BETY-Biopsychosocial Questionnaire in Familial Mediterranean Fever
- ClinicalTrials.gov ID
- NCT06830213
- Acronym / sponsor ID
- SBA 24/1114
- Conditions
- Familial Mediterranean Fever (FMF )
- Keywords
- Familial Mediterranean Fever, biopsychosocial, depression, social isolation, pain, sleep, functionality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aysima BarlakUniversity, hospital or other
- Study start
- 18 Feb 2025 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Feb 2025 (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.
FMF is associated with many different clinical entities. The disease appears to be associated with many diseases and/or syndromes with common features of genetic predisposition, immune dysfunction and autoinflammation. Pericardial inflammation, cardiovascular conditions such as ischaemic heart disease, other rheumatic diseases such as ankylosing spondylitis (AS), vasculitis, especially Behçet's disease, malignancy and infertility are often associated with FMF. Early detection of these associations makes it possible to improve the management and prognosis of patients with FMF.
The chronic nature of the disease, as in other chronic diseases, includes problems such as pain, fatigue, sleep problems, loss of function, anxiety, depression and social isolation. This complex structure is accompanied by a picture in which inflammatory processes are triggered.
When the literature is examined, it is emphasised that chronic diseases with multifaceted symptoms require evaluation and methods that include all these biopsychosocial features. On the other hand, although it is stated that the common goal of non-pharmacological treatments is to contribute to biopsychosocial improvement in the patient, it is emphasised that evaluations with biopsychosocial content are insufficient. This situation causes the need for scales that provide an assessment from a holistic perspective in chronic diseases.
Cognitive Exercise Therapy Approach (BETY) is an innovative exercise approach developed on the basis of biopsychosocial model on individuals with rheumatism. The parameters that constitute the innovation are detailed under four headings: function-oriented core stabilisation exercises, information management in pain, information management in mood, and information management in sexuality. This method has a unique scale that offers biopsychosocial assessment. The Cognitive Exercise Therapy Approach - Biopsychosocial Questionnaire (BETY-BQ) was created by receiving feedback from individuals with rheumatism who participated in BETY exercise training 3 days a week for many years, expressing the improvement characteristics they experienced by participating in exercise sessions. The BETY-BQ evaluates the individual biopsychosocially with six sub-headings: pain, functionality-fatigue, emotion-state, sociability, sexuality and sleep.
The validity, reliability and sensitivity of the BETY-BQ have been demonstrated in many rheumatic diseases such as rheumatoid arthritis, fibromyalgia, psoriatic arthritis, systemic lupus erythematosus, ankylosing spondylitis, knee osteoarthritis, primary Sjögren's syndrome. Currently, it is clear that there is a need for scales that offer biopsychosocial assessment for individuals diagnosed with rheumatism, where biopsychosocial approaches are recommended in EULAR recommendations. BETY-BQ is included in the EULAR library as a biopsychosocial status measurement tool. This study will investigate the validity, reliability and responsiveness of the BETY-BQ, a biopsychosocial assessment tool, in individuals diagnosed with Familial Mediterranean Fever.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals who come to the university hospital for routine controls.
Key inclusion criteria (4 listed)
- Having a diagnosis of Familial Mediterranean Fever
- Being literate
- Being 18 years of age or older
- Having read and signed the informed consent
Key exclusion criteria (4 listed)
- History of major psychiatric illness
- Malignant disease
- History of peripheral vascular disease or neuropathy
- Not volunteering for the study
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 |
|---|---|---|
| Questionnaire studyQuestionnaire application | Other | – |
Primary outcome
BETY-Biopsychosocial Questionnaire
Time frame: 3 mounths
The biopsychosocial status of the individual is assessed with questions about pain, functionality, mood, sociability, sexuality, and sleep status. Each question consists of 30 items scored between 0-120 as '0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), 4 (yes always)'. A high score indicates poor biopsychosocial status
5 secondary outcomes
Hospital Anxiety Depression Scale
Time frame: 3 mounths
Health Assessment Questionnaire
Time frame: 3 mounths
Short Form - 36
Time frame: 3 mounths
Pain Catastrophizing Scale
Time frame: 3 mounths
Fatigue Severity Scale
Time frame: 3 mounths
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Familial Mediterranean Fever (FMF )
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruitingPhase 3
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
Familial Mediterranean Fever, FMF
Not yet recruitingObservational study
Genotype and Phenotype in Pediatric Familial Mediterranean Fever
Familial Mediterranean Fever
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
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.
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 Familial Mediterranean Fever (FMF ), run by Aysima Barlak at 1 site in Turkey (Türkiye).
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 4 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: opening soon, as of the sponsor's last update on 19 Feb 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aysima Barlak, Licence (5412311754, fztasyimabarlak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BETY-Biopsychosocial Questionnaire (time frame: 3 mounths). 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 19 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.