Psychosomatic Assessment and Intervention in Fibromyalgia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Florence
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Psychosomatic status
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants will not be informed if they will receive the psychosomatic intervention or the control condition. At the end of the study they will receive this information.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: psychosomatic intervention based on cognitive restructuring. (Other)
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.
Intervention: Experimental and control condition: Museum therapy (Other)
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.
Intervention: Control condition (Behavioral)
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.
Intervention: Experimental and control condition: Museum therapy (Other)
Outcomes
Primary Outcomes
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)
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
- Feelings of loneliness and social isolation(change from baseline to 6-month follow up)
- Psychiatric status(change from baseline to 9-session of treatment)
- Psychological distress(change from baseline to 6-month follow up)
- Well-being(change from baseline to 6-month follow up)
- Mental pain(change from baseline to 6-month follow up)
Investigators
Fiammetta Cosci
Associate Professor in Clinical Psychology
University of Florence