Psychosomatic Intervention in Fibromyalgia.

Not Applicable

Recruiting

• Conditions: Fibromyalgia

• Registration Number: NCT06135753
• Lead Sponsor: University of Florence

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.

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Psychosomatic status	change from baseline to 9-session of treatment	Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview (Fava et al., 2017)
Level of distress, well-being and quality of life	change from baseline to 6-month follow up	The PsychoSocial Index (Piolanti et al., 2016)

Secondary Outcome Measures

Name	Time	Method
Psychiatric status	change from baseline to 9-session of treatment	Mini-International Neuropsychiatric Interview (Sheehan et al., 1998)
Mental pain	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)
Feelings of loneliness and social isolation	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)
Psychological distress	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)
Well-being	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)

Trial Locations

Locations (1)

Rheumtoi Unit, Academic Hospital Careggi; 🇮🇹 Firenze, Italia/firenze, Italy