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NCT06135753: PSY-FM
Psychosomatic Intervention in Fibromyalgia.
NA trial testing psychosomatic intervention based on cognitive restructuring. in Fibromyalgia in 100 participants. Currently enrolling.
30 December 2026
Quick facts
| Lead sponsor | University of Florence |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 November 2023 |
| Primary completion | 30 December 2026 |
| Estimated completion | 30 December 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- psychosomatic intervention based on cognitive restructuring.
- Control condition
- Experimental and control condition: Museum therapy
Conditions studied
- Fibromyalgia — all drugs for Fibromyalgia →
Sponsor
University of Florence
Who can join
18 and older, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06135753
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06135753 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Florence
- Last refreshed: 27 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06135753.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing