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Title: Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): Study Protocol of a Randomized Controlled Trial
Author: Serrat, Mayte
Sanabria Mazo, Juan P.
García Troiteiro, Elna
Fontcuberta, Anna
Mateo Canedo, Corel
Almirall, Míriam
Feliu Soler, Albert
Méndez Ulrich, Jorge Luis
Sanz Ruiz, Antoni
Luciano Devis, Juan Vicente
Keywords: Fibromiàlgia
Teràpia cognitiva
Teràpia cognitiva basada en l'atenció plena
Teràpia d'exposició
Exercici terapèutic
Cognitive therapy
Mindfulness-based cognitive therapy
Exposure therapy
Exercise therapy
Issue Date: 19-Jan-2020
Publisher: MDPI
Abstract: The study protocol of a prospective and randomized controlled trial for the assessment of the efficacy of nature activity therapy for people with Fibromyalgia (NAT-FM) is described. The primary outcome is the mean change from baseline in the Revised Fibromyalgia Impact Questionnaire (FIQR) score at post-treatment (12 weeks) and at 9 months of follow-up, and secondary outcomes are changes in the positive affect, negative affect, pain, fatigue, self-efficacy, catastrophising, and emotional regulation. A total of 160 patients with fibromyalgia will be divided into two arms: treatment-as-usual (TAU) and NAT-FM+TAU. Pre, during, post, +6, and +9 months assessments will be carried out, as well as an ecological momentary assessment (EMA) of intrasession and intersessions. Results will be subjected to a mixed group (NAT-FM+TAU vs. TAU) × phase (pre, post, +6 months, +9 months) general linear model. EMA intrasession measurements will be subjected to a 2 (pre vs. post) × 5 (type of activity) mixed-effects ANOVA. EMA between-session measurements obtained from both arms of the study will be analysed on both a time-domain and frequency-domain basis. Effect sizes and number needed to treat (NNT) will be computed. A mediation/moderation analysis will be conducted.
Note: Reproducció del document publicat a:
It is part of: International Journal of Environmental Research and Public Health, 2020, vol. 17, num. 2, p. 634
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ISSN: 1661-7827
Appears in Collections:Articles publicats en revistes (Mètodes d'Investigació i Diagnòstic en Educació)

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