[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526516":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":69,"collaborators":26,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":26,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Florence","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: psychosomatic intervention based on cognitive restructuring followed by Museum Therapy","EXPERIMENTAL","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.\n\nThe 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.\n\nA final additional session will be proposed.",[13,14],"Other: psychosomatic intervention based on cognitive restructuring.","Other: Experimental and control condition: Museum therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo Comparator: Control condition followed by Museum Therapy","PLACEBO_COMPARATOR","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:\u002F\u002Fwww.nice.org.uk\u002Fguidance\u002Flifestyleandwellbeing) and on World Health Organization 12 steps to healthy eating (http:\u002F\u002Fwww.euro.who.int\u002Fen\u002Fhealth-topics\u002Fdisease-prevention\u002Fnutrition\u002Fa-healthylifestyle). These sessions will inform participants about well-being and lifestyles which can influence it.\n\nThe 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.\n\nA final additional session will be proposed.",[20,14],"Behavioral: Control condition",[22,27,32],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"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.",[16],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"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).\n\nSession 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.",[9,16],[37],{"name":38,"affiliation":5,"role":39},"Fiammetta Cosci, MD, Prof.ssa","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":26,"email":44},"CONTACT","0552755066 Ext. 0039","fiammetta.cosci@unifi.it",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Rheumtoi Unit, Academic Hospital Careggi","RECRUITING","Florence","Italia\u002FFirenze","50135","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],11.24626,43.77925,{"lat":58,"lon":57},[61,64,66],{"name":62,"role":42,"phone":63,"phoneExt":26,"email":44},"Fiammetta Cosci MD, Phd","0552755066",{"name":65,"role":39,"phone":26,"phoneExt":26,"email":26},"Fiammetta Cosci MD, PhD",{"name":67,"role":68,"phone":26,"phoneExt":26,"email":26},"Sara Ceccatelli PhD","SUB_INVESTIGATOR",{"type":39,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Fiammetta Cosci","Associate Professor in Clinical Psychology","100526516","psychosomatic-intervention-in-fibromyalgia-100526516",false,"NCT06135753","Psychosomatic Intervention in Fibromyalgia.","Psychosomatic Assessment and Intervention in Fibromyalgia","PSY-FM","Inclusion Criteria:\n\n1. able and interested in participating to the research, as proved by signed Informed consent;\n2. a diagnosis of FM according to the Italian Society for Rheumatology clinical practice guidelines (Ariani et al., 2021)\n3. age higher than 18 years\n\nExclusion Criteria:\n\n1. 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;\n2. currently under psychotherapy;\n3. pharmacological modifications during the period of the trial;\n4. undergoing non pharmacological interventions during the period of the trial","ALL","18 Years",{"count":83,"type":84},100,"ESTIMATED","INTERVENTIONAL",[87],"NA","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\u002Fpsychoeducation 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.",[90],"Fibromyalgia",[90,92,93,94],"Psychosomatic Intervention","Cognitive Restructuring","Museum Therapy","2026-04-29",{"date":97,"type":98},"2026-05-05","ACTUAL",{"date":100,"type":98},"2023-11-01",{"date":102,"type":84},"2026-12-30",{"name":5,"class":6},1]