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

NCT05397080 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-06-02

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

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.

Sponsors & Collaborators

  • Universitat Autonoma de Barcelona

    collaborator OTHER

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-24
Primary Completion
2022-09-24
Completion
2022-11-24

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05397080 on ClinicalTrials.gov