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Psychosomatic Intervention in Fibromyalgia.

ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Florence

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • psychosomatic intervention based on cognitive restructuring.

    Other intervention

    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 condition

    Behavioral

    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 therapy

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Experimental: psychosomatic intervention based on cognitive restructuring followed by Museum TherapyExperimental treatment 2 interventions
Group B: Placebo Comparator: Control condition followed by Museum TherapyPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Psychosomatic status

Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview (Fava et al., 2017)

Time frame
change from baseline to 9-session of treatment
2

Level of distress, well-being and quality of life

The PsychoSocial Index (Piolanti et al., 2016)

Time frame
change from baseline to 6-month follow up

Secondary outcomes

1

Psychiatric status

Mini-International Neuropsychiatric Interview (Sheehan et al., 1998)

Time frame
change from baseline to 9-session of treatment
2

Psychological distress

Symptom Questionnaire (Fava et al., 1983); (min: 0, max: 92, the highest score corresponds to the highest level of psychological distress)

Time frame
change from baseline to 6-month follow up
3

Mental pain

Mental Pain Questionnaire (Fava, 2016); (min: 0, max: 20, the highest score corresponds to the highest level of mental pain)

Time frame
change from baseline to 6-month follow up
4

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)

Time frame
change from baseline to 6-month follow up

Other outcomes

Sponsors and contacts

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University of Florence

Lead sponsor

Source ClinicalTrials.gov
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