FibromyalgiaPSY-FMNCT06135753
Psychosomatic Intervention in Fibromyalgia.
A study testing psychosomatic intervention based on cognitive restructuring. in people with Fibromyalgia, run by University of Florence at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- psychosomatic intervention based on cognitive restructuring.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Rheumtoi Unit, Academic Hospital Careggi
Florence, Italia/Firenze, 50135
Fiammetta Cosci MD, Phd, 0552755066, fiammetta.cosci@unifi.it
Fiammetta Cosci MD, PhD
About this study
Official title: Psychosomatic Assessment and Intervention in Fibromyalgia
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- psychosomatic intervention based on cognitive restructuring., Control condition, Experimental and control condition: Museum therapy
- Keywords
- Fibromyalgia, Psychosomatic Intervention, Cognitive Restructuring, Museum Therapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosomatic intervention based on cognitive restructuring.Other
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.
Control conditionBehavioural
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.
Experimental and control condition: Museum therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.
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. Receives: Other: psychosomatic intervention based on cognitive restructuring.; Other: Experimental and control condition: Museum therapy |
| 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://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. Receives: Behavioral: Control condition; Other: Experimental and control condition: Museum therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosomatic status
Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview (Fava et al., 2017)
Measured: change from baseline to 9-session of treatment
Level of distress, well-being and quality of life
The PsychoSocial Index (Piolanti et al., 2016)
Measured: change from baseline to 6-month follow up
Secondary outcomes (5)
Psychiatric status
Mini-International Neuropsychiatric Interview (Sheehan et al., 1998)
Measured: change from baseline to 9-session of treatment
Psychological distress
Symptom Questionnaire (Fava et al., 1983); (min: 0, max: 92, the highest score corresponds to the highest level of psychological distress)
Measured: change from baseline to 6-month follow up
Mental pain
Mental Pain Questionnaire (Fava, 2016); (min: 0, max: 20, the highest score corresponds to the highest level of mental pain)
Measured: change from baseline to 6-month follow up
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)
Measured: change from baseline to 6-month follow up
Well-being
World Health Organization-Five Well-Being Index (min: 0, max: 25, the highest score corresponds to the lowest level of well-being)
Measured: change from baseline to 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Nov 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiammetta Cosci, University of Florence
- Investigators
- Fiammetta Cosci, MD, Prof.ssa, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135753
- Sponsor's protocol ID
- PSY-FM
- Acronym
- PSY-FM
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosomatic Assessment and Intervention in Fibromyalgia
- ClinicalTrials.gov ID
- NCT06135753
- Acronym / sponsor ID
- PSY-FM / PSY-FM
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Psychosomatic Intervention, Cognitive Restructuring, Museum Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: psychosomatic intervention based on cognitive restructuring followed by Museum Therapy | Experimental | Other: psychosomatic intervention based on cognitive restructuring., Other: Experimental and control condition: Museum therapyA 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. |
| Placebo Comparator: Control condition followed by Museum Therapy | Placebo comparator | Behavioral: Control condition, Other: Experimental and control condition: Museum therapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental: psychosomatic intervention based on cognitive restructuring followed by Museum Therapy |
| Control conditionThe 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. | Behavioural | Placebo Comparator: Control condition followed by Museum Therapy |
| Experimental and control condition: Museum therapySession 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. | Other | Experimental: psychosomatic intervention based on cognitive restructuring followed by Museum Therapy, Placebo Comparator: Control condition followed by Museum Therapy |
Primary outcome
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)
5 secondary outcomes
Psychiatric status
Time frame: change from baseline to 9-session of treatment
Psychological distress
Time frame: change from baseline to 6-month follow up
Mental pain
Time frame: change from baseline to 6-month follow up
Feelings of loneliness and social isolation
Time frame: change from baseline to 6-month follow up
Well-being
Time frame: change from baseline to 6-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fiammetta Cosci, MD, Prof.ssa principal investigator
University of Florence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychosomatic intervention based on cognitive restructuring. in people with Fibromyalgia, run by University of Florence at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fiammetta Cosci, MD, Prof.ssa (0552755066 Ext. 0039, fiammetta.cosci@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosomatic status (time frame: change from baseline to 9-session of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.