Psychosomatic Intervention in Fibromyalgia.
Recruiting · NCT06135753 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Florence
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Fibromyalgia is a widespread musculoskeletal pain syndrome. It is characterized by physical manifestations which are also the expression of a psychological distress as well as specific illness attitudes and behaviors. Indeed, it is considered a psychosomatic disorder. In this framework, we hypothesize the clinical utility of a psychosomatic assessment guided by rheumatologists and clinical psychologists (Study 1) and the utility of an integrated multidisciplinary psychosomatic intervention based on cognitive restructuring/psychoeducation followed by museum therapy (Study 2). For Study 1 a cross-sectional observation study will be implemented, for Study 2 a randomized controlled trial will be applied.
Who can take part
Inclusion criteria
- able and interested in participating to the research, as proved by signed Informed consent;
- a diagnosis of FM according to the Italian Society for Rheumatology clinical practice guidelines (Ariani et al., 2021)
- age higher than 18 years
Exclusion criteria
- co-occurrence of psychiatric disorder(s) according to the Diagnostic and Statistical Manual of mental disorders, 5th edition (American Psychiatric Association, 2013) as diagnosed via the Mini-International Neuropsychiatric Interview;
- currently under psychotherapy;
- pharmacological modifications during the period of the trial;
- undergoing non pharmacological interventions during the period of the trial
Where it is running
1 location listed.
- Rheumtoi Unit, Academic Hospital Careggi - Florence, Italia/Firenze, Italy