Clinical Trial

Psychosomatic Intervention in Fibromyalgia.

Study acronym: PSY-FM
Recruiting
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-11-13; most recent amendment 2026-04-29.
Trial Details
NCT Number NCT06135753
Lead Sponsor University of Florence
Conditions Fibromyalgia
Enrollment 100 participants
Start Date 2023-11-01
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-05