Psychosomatic Assessment and Intervention in Fibromyalgia

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• able and interested in participating to the research, as proved by signed Informed consent;

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

• age higher than 18 years

Locations
Other Locations
Italy
Rheumtoi Unit, Academic Hospital Careggi
RECRUITING
Florence
Contact Information
Primary
Fiammetta Cosci, MD, Prof.ssa
fiammetta.cosci@unifi.it
0552755066 Ext. 0039
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 100
Treatments
Experimental: Experimental: psychosomatic intervention based on cognitive restructuring followed by Museum Therapy
A psychosomatic intervention based on cognitive restructuring will be used as the non-pharmacological therapeutic strategy and 4 sessions will be delivered every other week with a duration of 120 minutes each in a group format with 10 participants.~The museum therapy will include 4 sessions, directed by the clinical psychologist and a museum educator, aimed at facilitating emotional expressions and participants' behavioral activation. The sessions will be delivered starting 2 weeks after the last session of the psychosomatic intervention as part of the Benessere al Museo Project by Uffizi Galleries.~A final additional session will be proposed.
Placebo_comparator: Placebo Comparator: Control condition followed by Museum Therapy
The control condition will include 4 every other week sessions based on Lifestyle and well-being National Institute for health and Care Excellence (NICE) Guidelines (https://www.nice.org.uk/guidance/lifestyleandwellbeing) and on World Health Organization 12 steps to healthy eating (http://www.euro.who.int/en/health-topics/disease-prevention/nutrition/a-healthylifestyle). These sessions will inform participants about well-being and lifestyles which can influence it.~The museum therapy will include 4 sessions, directed by the clinical psychologist and a museum educator, aimed at facilitating emotional expressions and participants' behavioral activation. The sessions will be delivered starting 2 weeks after the last control group's session as part of the Benessere al Museo Project by Uffizi Galleries.~A final additional session will be proposed.
Related Therapeutic Areas
Sponsors
Leads: University of Florence

This content was sourced from clinicaltrials.gov