Serrat, MayteSanabria Mazo, Juan P.García Troiteiro, ElnaFontcuberta, AnnaMateo Canedo, CorelAlmirall, MíriamFeliu Soler, AlbertMéndez Ulrich, Jorge LuisSanz Ruiz, AntoniLuciano Devis, Juan Vicente2021-01-152021-01-152020-01-191661-7827https://hdl.handle.net/2445/173166The 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.15 p.application/pdfengcc-by (c) Serrat, Mayte et al., 2020http://creativecommons.org/licenses/by/3.0/esFibromiàlgiaTeràpia cognitivaTeràpia cognitiva basada en l'atenció plenaTeràpia d'exposicióExercici terapèuticPsicoteràpiaFibromyalgiaCognitive therapyMindfulness-based cognitive therapyExposure therapyExercise therapyPsychotherapyinfo:eu-repo/semantics/article7056612021-01-15info:eu-repo/semantics/openAccess31963773