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.
Por:
Serrat M, Sanabria-Mazo JP, García-Troiteiro E, Fontcuberta A, Mateo-Canedo C, Almirall M, Feliu A, Méndez-Ulrich JL, Sanz A and Luciano JV
Publicada:
19 ene 2020
Ahead of Print:
19 ene 2020
Resumen:
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.
Filiaciones:
Serrat M:
Unitat d'Expertesa en Síndromes de Sensibilització Central, Hospital de la Vall d'Hebron, 08035 Barcelona, Spain
Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain
Escoles Universitàries Gimbernat, Universitat Autònoma de Barcelona, Sant Cugat del Vallès, 08174 Barcelona, Spain
Sanabria-Mazo JP:
Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain
Institut de Recerca Sant Joan de Déu, 08950 Esplugues de Llobregat, Spain
Teaching, Research, & Innovation Unit - Parc Sanitari Sant Joan de Déu, 08830 St. Boi de Llobregat, Spain
García-Troiteiro E:
Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain
Fontcuberta A:
Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain
Mateo-Canedo C:
Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain
Almirall M:
Unitat d'Expertesa en Síndromes de Sensibilització Central, Hospital de la Vall d'Hebron, 08035 Barcelona, Spain
Feliu A:
Teaching, Research, & Innovation Unit - Parc Sanitari Sant Joan de Déu, 08830 St. Boi de Llobregat, Spain
Institut de Recerca Sant Joan de Déu, 08950 Esplugues de Llobregat, Spain
Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain
Méndez-Ulrich JL:
Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain
Sanz A:
Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain
Luciano JV:
Teaching, Research, & Innovation Unit - Parc Sanitari Sant Joan de Déu, 08830 St. Boi de Llobregat, Spain
Institut de Recerca Sant Joan de Déu, 08950 Esplugues de Llobregat, Spain
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