Efficacy of NAT-FM Treatment for Fibromyalgia

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Fibromyalgia

Treatments: Behavioral: Treatment as Usual (TAU); Behavioral: TAU + multicomponent treatment NAT-FM

Study type: Interventional

Funder types: Other

Identifiers

NCT04190771

NAT-FM

Details and patient eligibility

About

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.

Full description

• This is a two-arm RCT focused on the safety and potential efficacy of the multicomponent program NAT-FM as coadjuvant of treatment-as-usual (TAU) vs. TAU alone.
• NAT-FM combines Classical Structural Assessment (CSA) and Ecological Momentary Assessment (EMA) to obtain more reliable information about the dynamics of the variables to be evaluated, to record the affective and cognitive impact of each activity, and to explore its potential delivery in real-world clinical practice.
• The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as self-efficacy and pain catastrophizing.

Enrollment: 169 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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169 participants in 2 patient groups

TAU + multicomponent treatment NAT-FM

Experimental group

Description:

NAT-FM is a multicomponent non-pharmacological program based on mindfulness ingredients, pain neuroscience education, and nature exposure. NAT-FM is conceived as an add-on therapy.

Treatment:

Behavioral: Treatment as Usual (TAU)

Behavioral: TAU + multicomponent treatment NAT-FM

Treatment as Usual (TAU)

Active Comparator group

Description:

Standard Care. Although there is no treatment considered as the gold standard for fibromyalgia, the standard treatment is usually mainly pharmacological and conforms to the symptomatic profile of each patient.

Treatment:

Behavioral: Treatment as Usual (TAU)