Exploring psychological treatments for chronic pain in fibromyalgia and migraines
Relieving Chronic Pain: Psychosomatic Mechanisms and Psychological Interventions in Fibromyalgia and Chronic Headache
This study is testing different psychological treatments to see if they can help people with fibromyalgia, chronic migraines, or both feel less pain and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 2 sites (Rome, RM and 1 other locations) |
| Trial ID | NCT06652724 on ClinicalTrials.gov |
What this trial studies
This research project aims to investigate the psychological and neurofunctional differences between patients with fibromyalgia (FM), chronic migraine (CM), and those with both conditions (FibroMig). The study will assess psychosocial variables and evaluate the effectiveness of brief psychodynamic treatments, expressive writing techniques, and standard care on pain severity and quality of life. By understanding the underlying mechanisms of these chronic pain conditions, the study seeks to improve treatment strategies for affected individuals.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with fibromyalgia, chronic migraine, or both, who meet specific educational and health criteria.
Not a fit: Patients with severe psychiatric disorders, cognitive impairments, or other chronic pain conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective psychological interventions for managing chronic pain in patients with fibromyalgia and chronic migraines.
How similar studies have performed: Other studies have shown promise in using psychological interventions for chronic pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * minimum age of 18 years; * at least 5 years of education; * FM diagnosis according to the criteria reported by Wolfe (2016) for the FM group; * CM diagnosis according to Olesen (2018) for the CM group; * medical certification for FM and CM diagnosis for FibroMig group. Exclusion Criteria: * severe psychiatric disorders and/or cognitive impairment; * difficulty understanding/expressing in Italian; * history of other disorders characterized by chronic pain for FM and CM; * history of other neurological disorders besides migraine for CM and FibroMig; * history of other rheumatological disorders besides fibromyalgia for FM and FibroMig; * For the healthy control group: no diagnosis of FM or CM; no severe psychiatric disorders/cognitive impairment; no or low levels of depression; no history of rheumatological and/or neurological disorders.
Where this trial is running
Rome, RM and 1 other locations
- Sapienza University of Rome — Rome, Rm, Italy (Enrolling_by_invitation)
- Department of Dynamic and Clinical Psychology and Health Studies — Rome, Rm, Italy (Recruiting)
Study contacts
- Principal investigator: Federica Galli, Professor — University of Roma La Sapienza
- Study coordinator: Federica Galli, Professor
- Email: f.galli@uniroma1.it
- Phone: 3355492778
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.