Clinical trial NCT06830213: Investigation of the Validity, Reliability and Responsiveness of the BETY-BQ in FMF
Official title: Investigation of the Validity, Reliability and Responsiveness of the BETY-Biopsychosocial Questionnaire in Familial Mediterranean Fever
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Familial Mediterranean Fever (FMF )
Keywords: Familial Mediterranean Fever
biopsychosocial
depression
social isolation
pain
sleep
functionality
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of individuals who come to the university hospital for routine controls.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of Familial Mediterranean Fever
* Being literate
* Being 18 years of age or older
* Having read and signed the informed consent

Exclusion Criteria:

* History of major psychiatric illness
* Malignant disease
* History of peripheral vascular disease or neuropathy
* Not volunteering for the study

Primary outcomes:
measure: BETY-Biopsychosocial Questionnaire
timeFrame: 3 mounths
Secondary outcomes:
measure: Hospital Anxiety Depression Scale
timeFrame: 3 mounths
measure: Health Assessment Questionnaire
timeFrame: 3 mounths
measure: Short Form - 36
timeFrame: 3 mounths
measure: Pain Catastrophizing Scale
timeFrame: 3 mounths
measure: Fatigue Severity Scale
timeFrame: 3 mounths
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
References: