NCT05397080

Effectiveness of Video-based Multicomponent Treatment for Fibromyalgia Plus Face-to-face Sesions

Effectiveness of Two Video-based Multicomponent Treatments for Fibromyalgia: The Added Value of Face-to-face Sesions in a Three-arm Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to examine the effectiveness of two video-based multicomponent programs: Fibrowalk Virtual and the Fibrowalk Virtual plus face-to-face sessions for patients with fibromyalgia (FM) compared to treatment-as-usual (TAU) only. The investigators posit that Fibrowalk Virtual plus face-to-face sessions, due to the best results obtained with the Fibrowalk carried out completely face-to-face versus the results of the Fibrowalk Virtual, can help patients with FM to experience more ubiquitous clinical improvement than TAU or Fibrowalk Virtual alone.

Detailed description

Fibrowalk therapy has shown better results when performed in a natural environment face-to-face. Due to the state of the pandemic, it is necessary to study different forms of approach. It is proposed what number of face-to-face sessions would be necessary to add to the virtual Fibrowalk program to achieve the same or similar effectiveness as in the totally face-to-face format. This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatmentas- usual (TAU) vs. TAU alone and on the comparation of the FACE-TO-FACE SESSIONS ADDED TO VIRTUAL FIBROWALK. * 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. * 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

• Fibromyalgia

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Treatment as Usual (TAU)	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.
BEHAVIORAL	TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions	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) Standard pharmacological treatment usually provided to patients with fibromyalgia.

Timeline

• Start date: 2022-05-24
• Primary completion: 2022-09-24
• Completion: 2022-11-24
• First posted: 2022-05-31
• Last updated: 2022-06-02

Locations

1 site across 1 country: Spain