Effectiveness of Video-based Multicomponent Treatment for Fibromyalgia Plus Face-to-face Sesions in Nature or at Sea

Vall d'Hebron University Hospital (HUVH)

Status: Active, not recruiting

Conditions: Fibromyalgia

Treatments: Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions at sea; Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK; Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions in nature

Study type: Interventional

Funder types: Other

Identifiers

NCT05395832

FIBROWALK NATURE

Details and patient eligibility

About

The aim of this study was to examine the effectiveness of a video-based multicomponent program: the Fibrowalk Virtual plus face-to-face sessions for patients with fibromyalgia (FM) in nature or at sea (FM) compared to Fibrowalk Virtual only.

Full description

This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as- usual (TAU) in comparation of the Fibrowalk virtual plus face-to-face sessions in the nature or at sea.

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

Enrollment: 109 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults from 18 to 75 years-old. 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified - - - ACR diagnostic criteria for fibromyalgia
• Able to understand Spanish and accept to participate in the study.

Exclusion criteria

• Participating in concurrent or past RCTs (previous year).
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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109 participants in 3 patient groups

TAU + multicomponent treatment VIRTUAL FIBROWALK at sea

Experimental group

Description:

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

Treatment:

Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions at sea

TAU + multicomponent treatment VIRTUAL FIBROWALK in nature

Active Comparator group

Description:

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

Treatment:

Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions in nature

TAU + multicomponent treatment VIRTUAL FIBROWALK

Active Comparator group

Description:

VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training

Treatment:

Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK