Psychosomatic Intervention in Fibromyalgia.

Fibromyalgia Clinical Trial

— PSY-FM  

Official title:

Psychosomatic Assessment and Intervention in Fibromyalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135753
• Other study ID #: PSY-FM
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: November 2023
• Source: University of Florence
• Contact: Fiammetta Cosci, MD, Prof.ssa
• Phone: 0552755066 Ext. 0039
• Email: fiammetta.cosci[@]unifi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• 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.

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Italy	Rheumtoi Unit, Academic Hospital Careggi	Firenze	Italia/firenze

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychosomatic status	Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview (Fava et al., 2017)	change from baseline to 9-session of treatment
Primary	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	Psychiatric status	Mini-International Neuropsychiatric Interview (Sheehan et al., 1998)	change from baseline to 9-session of treatment
Secondary	Psychological distress	Symptom Questionnaire (Fava et al., 1983); (min: 0, max: 92, the highest score corresponds to the highest level of psychological distress)	change from baseline to 6-month follow up
Secondary	Mental pain	Mental Pain Questionnaire (Fava, 2016); (min: 0, max: 20, the highest score corresponds to the highest level of mental pain)	change from baseline to 6-month follow up
Secondary	Feelings of loneliness and social isolation	the UCLA Loneliness Scale (Russell et al., 1980); (20 items, the highest score corresponds to the highest level of feelings of lolliness)	change from baseline to 6-month follow up
Secondary	Well-being	World Health Organization-Five Well-Being Index (min: 0, max: 25, the highest score corresponds to the lowest level of well-being)	change from baseline to 6-month follow up