Psychosomatic intervention for fibromyalgia treatment
Psychosomatic Assessment and Intervention in Fibromyalgia
This study tests a new treatment that combines mental health support with museum visits to see if it helps people with fibromyalgia feel better compared to just going to the museum.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florence Academic / other |
| Locations | 1 site (Florence, Italia/Firenze) |
| Trial ID | NCT06135753 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have a diagnosis of fibromyalgia according to established clinical guidelines.
Not a fit: Patients with co-occurring psychiatric disorders, those currently undergoing psychotherapy, or those experiencing pharmacological changes during the trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with fibromyalgia by addressing both psychological and physical aspects of the condition.
How similar studies have performed: While the approach of integrating psychosomatic interventions in fibromyalgia treatment is innovative, similar multidisciplinary strategies have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Florence, Italia/Firenze
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.