Psychosomatic intervention for fibromyalgia treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the psychological status of individuals with fibromyalgia (FM) through a psychosomatic assessment conducted by rheumatologists and clinical psychologists. It will then test the efficacy of a multidisciplinary psychosomatic intervention that combines cognitive restructuring with museum therapy, compared to a control condition followed by museum therapy. The study consists of a cross-sectional observational component and a randomized controlled trial to assess the outcomes of the interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. able and interested in participating to the research, as proved by signed Informed consent;
2. a diagnosis of FM according to the Italian Society for Rheumatology clinical practice guidelines (Ariani et al., 2021)
3. age higher than 18 years

Exclusion Criteria:

1. 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;
2. currently under psychotherapy;
3. pharmacological modifications during the period of the trial;
4. undergoing non pharmacological interventions during the period of the trial

Where it's running

• Rheumtoi Unit, Academic Hospital Careggi
  Florence, Italia/Firenze, Italy Recruiting

Study contacts

• Principal investigator: Fiammetta Cosci, MD, Prof.ssa — University of Florence
• Study coordinator: Fiammetta Cosci, MD, Prof.ssa
• Email: fiammetta.cosci@unifi.it
• Phone: 0552755066 Ext. 0039

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.