Psychosomatic Intervention in Fibromyalgia.

NCT06135753 | Recruiting

• 1 other identifier: PSY-FM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Psychosomatic Intervention; Cognitive Restructuring; Museum Therapy

Outcome Measures

Primary Outcomes (2)

• Psychosomatic status

  Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview (Fava et al., 2017)

  change from baseline to 9-session of treatment

• Level of distress, well-being and quality of life

  The PsychoSocial Index (Piolanti et al., 2016)

  change from baseline to 6-month follow up

Secondary Outcomes (5)

• Psychiatric status

  change from baseline to 9-session of treatment

• Psychological distress

  change from baseline to 6-month follow up

• Mental pain

  change from baseline to 6-month follow up

• Feelings of loneliness and social isolation

  change from baseline to 6-month follow up

• Well-being

  change from baseline to 6-month follow up

Study Arms (2)

Experimental: psychosomatic intervention based on cognitive restructuring followed by Museum Therapy

EXPERIMENTAL

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.

Other: psychosomatic intervention based on cognitive restructuring.; Other: Experimental and control condition: Museum therapy

Placebo Comparator: Control condition followed by Museum Therapy

PLACEBO COMPARATOR

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.

Behavioral: Control condition; Other: Experimental and control condition: Museum therapy

Interventions

Experimental and control condition: Museum therapy OTHER

Session 5-6-7: preselected painting works from the Uffizi Galleries (Florence) will be presented to the participants in order to trigger reflections and emotional responses on specific pain related topics. Session 8: visit the Galleria di Arte Moderna at Palazzo Pitti, in person. Each session will be aimed at facilitating emotional expressions and partecipants' behavioral activation and identifying thoughts associated with those emotions and, if appropriate, remodulating them in a functional way (cognitive restructuring). Session 9: share the experience of the previous meetings and to recap strategies and skills which could be implemented in FM participants' daily life to cope with their illness.

Experimental: psychosomatic intervention based on cognitive restructuring followed by Museum Therapy; Placebo Comparator: Control condition followed by Museum Therapy

psychosomatic intervention based on cognitive restructuring. OTHER

Participants will receive information on psychosomatic phenomena and over-listening of somatic manifestations (Session 1), interpretation and possible catastrophization of somatic manifestations even when they might be well-known health problems or potential physiological or para-physiological manifestations (Session 2), pain-proneness (Session 3) and mental pain and psychological distress in somatizers (Session 4). The second part of each session will be devoted to group cognitive restructuring, thus participants will be stimulated in verifying how the phenomena illustrated are in their lives and how they can be differently conceptualized in order to be less intrusive and less able to reduce their own functioning.

Experimental: psychosomatic intervention based on cognitive restructuring followed by Museum Therapy

Control condition BEHAVIORAL

The control condition will include 4 sessions that will inform participants about well-being and lifestyles which can influence it. They will be articulated as follows. Session 1: illustrating the concept of lifestyle and well-being. Session 2 and session 3: illustrating healthy eating and steps to healthy eating. Session 4: illustrating physical exercise and how it promotes health.

Placebo Comparator: Control condition followed by Museum Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• currently under psychotherapy;
• pharmacological modifications during the period of the trial;
• undergoing non pharmacological interventions during the period of the trial

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Rheumtoi Unit, Academic Hospital Careggi

Florence, Italia/Firenze, 50135, Italy

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Fiammetta Cosci, MD, Prof.ssa

  University of Florence

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiammetta Cosci, MD, Prof.ssa

CONTACT

0552755066 Ext. 0039; fiammetta.cosci@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed if they will receive the psychosomatic intervention or the control condition. At the end of the study they will receive this information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Clinical Psychology

Model Details: This is a pilot study, designed as a cross-sectional observation study (study 1) and as a randomized (1:1) controlled trial, comparing a multidisciplinary psychosomatic intervention based on cognitive restructuring vs a control condition both followed by museum therapy (study 2). The participants will receive a baseline psychosomatic assessment to confirm the diagnosis of fibromyalgia, then socio-demographic information, information on pharmacological/non-pharmacological treatments, on the history of medical diseases and on the psychological status will be collected. Thereafter, the subjects will be randomly assigned to experimental group or to a control condition. The subjects will be re-assessed at the end of session 4, and at the end of session 7, 8, 9 of museum therapy and at 3 and 6-month follow-up.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)