Psychosomatic Intervention in Fibromyalgia.

Last updated: March 24, 2025
Sponsor: University of Florence
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fibromyalgia

Treatment

Experimental and control condition: Museum therapy

psychosomatic intervention based on cognitive restructuring.

Control condition

Clinical Study ID

NCT06135753
PSY-FM
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. able and interested in participating to the research, as proved by signed Informedconsent;

  2. a diagnosis of FM according to the Italian Society for Rheumatology clinicalpractice guidelines (Ariani et al., 2021)

  3. age higher than 18 years

Exclusion

Exclusion Criteria:

  1. co-occurrence of psychiatric disorder(s) according to the Diagnostic and StatisticalManual of mental disorders, 5th edition (American Psychiatric Association, 2013) asdiagnosed via the Mini-International Neuropsychiatric Interview;

  2. currently under psychotherapy;

  3. pharmacological modifications during the period of the trial;

  4. undergoing non pharmacological interventions during the period of the trial

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Experimental and control condition: Museum therapy
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
December 30, 2026

Study Description

Fibromyalgia (FM) is a widespread musculoskeletal pain syndrome characterized by chronic widespread pain, unrefreshing sleep, physical exhaustion, and cognitive difficulties. It occurs in all populations throughout the world, with prevalence between 2% and 4% in general populations. Definition, pathogenesis, diagnosis, and treatment of FM remain points of contention. There is no specific diagnostic laboratory test or biomarker to support the diagnostic process and the diagnosis is clinical. For this reason, rheumatologists and clinical psychologists are strongly involved in the diagnostic process and might benefit from tools for comprehensive psychosomatic assessment. Also the treatment of FM remains a challenge, because pharmacological interventions don't consider psychological and social problems and non-pharmacological treatments have shown poor efficacy and are often tested via non-rigorous methods. A multidisciplinary approach which include biological aspects and psychological one, under comprehensive psychosomatic principles, seem to be the best choice for FM.

The primary aim of the present study is to evaluate the psychological status of FM subjects, focusing on a psychosomatic assessment and then testing the efficacy of a multidisciplinary psychosomatic intervention based on cognitive restructuring followed by museum therapy vs a control condition followed by museum therapy.

Connect with a study center

  • Rheumtoi Unit, Academic Hospital Careggi

    Firenze, Italia/firenze 50135
    Italy

    Active - Recruiting

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