Clinical trial NCT06135753: Psychosomatic Intervention in Fibromyalgia.
Official title: Psychosomatic Assessment and Intervention in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Psychosomatic Intervention
Cognitive Restructuring
Museum Therapy
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Psychosomatic status
timeFrame: change from baseline to 9-session of treatment
measure: Level of distress, well-being and quality of life
timeFrame: change from baseline to 6-month follow up
Secondary outcomes:
measure: Psychiatric status
timeFrame: change from baseline to 9-session of treatment
measure: Psychological distress
timeFrame: change from baseline to 6-month follow up
measure: Mental pain
timeFrame: change from baseline to 6-month follow up
measure: Feelings of loneliness and social isolation
timeFrame: change from baseline to 6-month follow up
measure: Well-being
timeFrame: change from baseline to 6-month follow up
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Rheumtoi Unit, Academic Hospital Careggi
state: Italia/firenze
Study officials:
affiliation: University of Florence
name: Fiammetta Cosci, MD, Prof.ssa
role: PRINCIPAL_INVESTIGATOR
References: