Cost-utility of VIRTUAL FIBROWALK

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Fibromyoma;Cervix

Treatments: Behavioral: Multicomponent treatment VIRTUAL FIBROWALK + TAU

Study type: Interventional

Funder types: Other

Identifiers

NCT05091697

COST-UTILITY VIIRTUAL FW

Details and patient eligibility

About

The main objective of this study is to assess the effectiveness and cost-utility of the VIRTUAL FIBROWALK multicomponent treatment program as coadjuvant of treatment-as- usual (TAU) compared to TAU alone.

Full description

This is a two-arm RCT focused on the effectiveness and cost-utility of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as- usual (TAU) vs. TAU alone (in a 3-month follow-up RCT) VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.

Enrollment: 142 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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142 participants in 2 patient groups

Multicomponent treatment VIRTUAL FIBROWALK + TAU

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

Treatment:

Behavioral: Multicomponent treatment VIRTUAL FIBROWALK + TAU

Treatment as Usual (TAU)

Active Comparator group

Description:

Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study.patient

Treatment:

Behavioral: Multicomponent treatment VIRTUAL FIBROWALK + TAU