Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06135753

Psychosomatic Intervention in Fibromyalgia.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rheumtoi Unit, Academic Hospital Careggi

Florence, Italia/Firenze, 50135, Italy

Location status: Recruiting

Location contact

Fiammetta Cosci MD, PhD

PRINCIPAL_INVESTIGATOR

Fiammetta Cosci MD, Phd

CONTACT

[email protected]

0552755066

Sara Ceccatelli PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Psychosomatic status

    Time frame: change from baseline to 9-session of treatment

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

  2. Level of distress, well-being and quality of life

    Time frame: change from baseline to 6-month follow up

    The PsychoSocial Index (Piolanti et al., 2016)

Secondary outcomes

  1. Psychiatric status

    Time frame: change from baseline to 9-session of treatment

    Mini-International Neuropsychiatric Interview (Sheehan et al., 1998)

  2. Psychological distress

    Time frame: change from baseline to 6-month follow up

    Symptom Questionnaire (Fava et al., 1983); (min: 0, max: 92, the highest score corresponds to the highest level of psychological distress)

  3. Mental pain

    Time frame: change from baseline to 6-month follow up

    Mental Pain Questionnaire (Fava, 2016); (min: 0, max: 20, the highest score corresponds to the highest level of mental pain)

  4. Feelings of loneliness and social isolation

    Time frame: change from baseline to 6-month follow up

    the UCLA Loneliness Scale (Russell et al., 1980); (20 items, the highest score corresponds to the highest level of feelings of lolliness)

  5. Well-being

    Time frame: change from baseline to 6-month follow up

    World Health Organization-Five Well-Being Index (min: 0, max: 25, the highest score corresponds to the lowest level of well-being)

Study contacts

Contact information is provided by the study sponsor or research team.

Fiammetta Cosci, MD, Prof.ssa

CONTACT

[email protected]

0552755066 Ext. 0039

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

Psychosomatic Assessment and Intervention in Fibromyalgia

Acronym: PSY-FM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.