Psychosomatic Intervention in Fibromyalgia.

NCT ID: NCT06135753

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-12-30

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.

Detailed Description

Fibromyalgia (FM) is a widespread musculoskeletal pain syndrome characterized by chronic widespread pain, unrefreshing sleep, physical exhaustion, and cognitive difficulties. It occurs in all populations throughout the world, with prevalence between 2% and 4% in general populations. Definition, pathogenesis, diagnosis, and treatment of FM remain points of contention. There is no specific diagnostic laboratory test or biomarker to support the diagnostic process and the diagnosis is clinical. For this reason, rheumatologists and clinical psychologists are strongly involved in the diagnostic process and might benefit from tools for comprehensive psychosomatic assessment. Also the treatment of FM remains a challenge, because pharmacological interventions don't consider psychological and social problems and non-pharmacological treatments have shown poor efficacy and are often tested via non-rigorous methods. A multidisciplinary approach which include biological aspects and psychological one, under comprehensive psychosomatic principles, seem to be the best choice for FM.

The primary aim of the present study is to evaluate the psychological status of FM subjects, focusing on a psychosomatic assessment and then testing the efficacy of a multidisciplinary psychosomatic intervention based on cognitive restructuring followed by museum therapy vs a control condition followed by museum therapy.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

psychosomatic intervention based on cognitive restructuring.

Intervention Type: 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 and control condition: Museum therapy

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Control condition

Intervention Type: 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.

Experimental and control condition: Museum therapy

Intervention Type: 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.

Interventions

psychosomatic intervention based on cognitive restructuring.

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.

Intervention Type: OTHER

Control condition

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.

Intervention Type: BEHAVIORAL

Experimental and control condition: Museum therapy

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florence

OTHER

Sponsor Role: lead

Responsible Party

Fiammetta Cosci

Associate Professor in Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fiammetta Cosci, MD, Prof.ssa

Role: PRINCIPAL_INVESTIGATOR

University of Florence

Locations

Rheumtoi Unit, Academic Hospital Careggi

Florence, Italia/firenze, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fiammetta Cosci, MD, Prof.ssa

Role: CONTACT

fiammetta.cosci@unifi.it

0552755066 Ext. 0039

Facility Contacts

Fiammetta Cosci MD, Phd

Role: primary

fiammetta.cosci@unifi.it

0552755066

Other Identifiers

PSY-FM

Identifier Type: -

Identifier Source: org_study_id