NCT04190771

Efficacy of NAT-FM Treatment for Fibromyalgia

Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Physical Activity, Psychological Support, and Nature Exposure (NAT-FM)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-02-29
• Completion: 2020-02-29
• First posted: 2019-12-09
• Last updated: 2020-10-19

Locations

1 site across 1 country: Spain