Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06135753

Psychosomatic Intervention in Fibromyalgia.

Led by University of Florence · Updated on 2026-05-05

100

Participants Needed

1

Research Sites

165 weeks

Total Duration

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AI-Summary

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.

CONDITIONS

Official Title

Psychosomatic Intervention in Fibromyalgia.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and interested in participating in the research, confirmed by signed informed consent
  • Diagnosed with fibromyalgia according to Italian Society for Rheumatology guidelines
  • Age over 18 years
Not Eligible

You will not qualify if you...

  • Having a psychiatric disorder diagnosed by the Mini-International Neuropsychiatric Interview
  • Currently undergoing psychotherapy
  • Changing medications during the trial period
  • Receiving non-pharmacological treatments during the trial period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rheumtoi Unit, Academic Hospital Careggi

Florence, Italia/Firenze, Italy, 50135

Actively Recruiting

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Research Team

F

Fiammetta Cosci, MD, Prof.ssa

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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