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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

1
Unitat d’Expertesa en Síndromes de Sensibilització Central, Hospital de la Vall d’Hebron, 08035 Barcelona, Spain
2
Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain
3
Escoles Universitàries Gimbernat, Universitat Autònoma de Barcelona, Sant Cugat del Vallès, 08174 Barcelona, Spain
4
Institut de Recerca Sant Joan de Déu, 08950 Esplugues de Llobregat, Spain
5
Teaching, Research, & Innovation Unit - Parc Sanitari Sant Joan de Déu, 08830 St. Boi de Llobregat, Spain
*
Authors to whom correspondence should be addressed.
These authors have contributed equally to this work and are co-first authors.
Int. J. Environ. Res. Public Health 2020, 17(2), 634; https://doi.org/10.3390/ijerph17020634
Received: 30 December 2019 / Revised: 12 January 2020 / Accepted: 14 January 2020 / Published: 19 January 2020
(This article belongs to the Special Issue Physical Activity and Mental Health)
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. View Full-Text
Keywords: fibromyalgia; multicomponent treatment; pain neuroscience education; exercise therapy; cognitive behavioural therapy; nature exposure; randomized controlled trial; ecological momentary assessment; study protocol fibromyalgia; multicomponent treatment; pain neuroscience education; exercise therapy; cognitive behavioural therapy; nature exposure; randomized controlled trial; ecological momentary assessment; study protocol
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Serrat, M.; Sanabria-Mazo, J.P.; García-Troiteiro, E.; Fontcuberta, A.; Mateo-Canedo, C.; Almirall, M.; Feliu-Soler, A.; Méndez-Ulrich, J.L.; Sanz, A.; Luciano, J.V. 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. Int. J. Environ. Res. Public Health 2020, 17, 634.

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