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Efficacy of NAT-FM Treatment for Fibromyalgia

NCT04190771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2020-10-19

No results posted yet for this study

Summary

The main objective of this study is to analyse the efficacy of the NAT-FM multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone.

In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of NAT-FM treatment in the short- and long-term, the research team will seek to identify relevant moderators and mediators of clinical change.

Conditions

  • Fibromyalgia

Interventions

BEHAVIORAL

TAU + multicomponent treatment NAT-FM

Group treatment protocol of 12 weekly 120 minute sessions. All sessions include the following ingredients (approx. in the same order): * Pain neuroscience education (30 min.) * Cognitive restructuring (30 min.) * Mindfulness techniques (30 min.) * Physical exercise in a natural environment / nature exposure (30 min.) Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.

BEHAVIORAL

Treatment as Usual (TAU)

Standard pharmacological treatment usually provided to patients with fibromyalgia.

Sponsors & Collaborators

  • Parc Sanitari Sant Joan de Déu

    collaborator OTHER

  • Universitat Autonoma de Barcelona

    collaborator OTHER

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Sara Marsal Barril, PhD · Vall d'Hebrón Hospital

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
2019-09-01
Primary Completion
2020-02-29
Completion
2020-02-29

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 NCT04190771 on ClinicalTrials.gov