Effectiveness of Video-based Multicomponent Treatment for Fibromyalgia Plus Face-to-face Sesions in Nature or at Sea
NCT ID: NCT05395832
Last Updated: 2022-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
109 participants
INTERVENTIONAL
2022-04-25
2023-02-23
Brief Summary
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Detailed Description
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VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.
FACE-TO-FACE SESSIONS ADDED TO VIRTUAL FIBROWALK combines de same components than Fibrowalk Virtual and added 4 face-to-face sessions (1 per mounth) to resolve doubts and reinforce the main concepts of therapy in the nature or at sea.
The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia and fear avoidance
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TAU + multicomponent treatment VIRTUAL FIBROWALK at sea
VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training. In this arm a 4 face-to-face session at sea will be added to solve doubts and emphasize the most important points of therapy
TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions at sea
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order):
Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) 4 face-to-face sessions (1 per mounth) at sea Standard pharmacological treatment usually provided to patients with fibromyalgia.
TAU + multicomponent treatment VIRTUAL FIBROWALK in nature
VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training. In this arm a 4 face-to-face session in nature will be added to solve doubts and emphasize the most important points of therapy
TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions in nature
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order):
Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) 4 face-to-face sessions (1 per mounth) in nature Standard pharmacological treatment usually provided to patients with fibromyalgia.
TAU + multicomponent treatment VIRTUAL FIBROWALK
VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
TAU + multicomponent treatment VIRTUAL FIBROWALK
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order):
Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.
Interventions
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TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions at sea
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order):
Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) 4 face-to-face sessions (1 per mounth) at sea Standard pharmacological treatment usually provided to patients with fibromyalgia.
TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions in nature
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order):
Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) 4 face-to-face sessions (1 per mounth) in nature Standard pharmacological treatment usually provided to patients with fibromyalgia.
TAU + multicomponent treatment VIRTUAL FIBROWALK
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order):
Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.
Eligibility Criteria
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Inclusion Criteria
* Able to understand Spanish and accept to participate in the study.
Exclusion Criteria
* Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.
18 Years
75 Years
ALL
No
Sponsors
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Universitat Autonoma de Barcelona
OTHER
Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Locations
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Hospital Vall Hebron
Barcelona, , Spain
Countries
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Other Identifiers
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FIBROWALK NATURE
Identifier Type: -
Identifier Source: org_study_id
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