Efficacy of NAT-FM Treatment for Fibromyalgia

NCT ID: NCT04190771

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-02-29

Brief 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.

Detailed 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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TAU + multicomponent treatment NAT-FM

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.

Group Type: EXPERIMENTAL

TAU + multicomponent treatment NAT-FM

Intervention Type: BEHAVIORAL

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.

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Standard pharmacological treatment usually provided to patients with fibromyalgia.

Treatment as Usual (TAU)

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Standard pharmacological treatment usually provided to patients with fibromyalgia.

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

Standard pharmacological treatment usually provided to patients with fibromyalgia.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc Sanitari Sant Joan de Déu

OTHER

Sponsor Role: collaborator

Universitat Autonoma de Barcelona

OTHER

Sponsor Role: collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara Marsal Barril, PhD

Role: STUDY_CHAIR

Vall d'Hebrón Hospital

Locations

Vall d'Hebrón Hospital

Barcelona, , Spain

Countries

Spain

Other Identifiers

NAT-FM

Identifier Type: -

Identifier Source: org_study_id