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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

Author

Listed:
  • Mayte Serrat

    (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
    These authors have contributed equally to this work and are co-first authors.)

  • Juan P. Sanabria-Mazo

    (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
    These authors have contributed equally to this work and are co-first authors.)

  • Elna García-Troiteiro

    (Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain)

  • Anna Fontcuberta

    (Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain)

  • Corel Mateo-Canedo

    (Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain)

  • Míriam Almirall

    (Unitat d’Expertesa en Síndromes de Sensibilització Central, Hospital de la Vall d’Hebron, 08035 Barcelona, Spain)

  • Albert Feliu-Soler

    (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)

  • Jorge Luis Méndez-Ulrich

    (Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain)

  • Antoni Sanz

    (Research Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain)

  • Juan V. Luciano

    (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)

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.

Suggested Citation

  • Mayte Serrat & Juan P. Sanabria-Mazo & Elna García-Troiteiro & Anna Fontcuberta & Corel Mateo-Canedo & Míriam Almirall & Albert Feliu-Soler & Jorge Luis Méndez-Ulrich & Antoni Sanz & Juan V. Luciano, 2020. "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 C," IJERPH, MDPI, vol. 17(2), pages 1-15, January.
    • Handle: RePEc:gam:jijerp:v:17:y:2020:i:2:p:634-:d:310465
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    References listed on IDEAS

    as
    1. Bowen, Daniel J. & Neill, James T. & Crisp, Simon J.R., 2016. "Wilderness adventure therapy effects on the mental health of youth participants," Evaluation and Program Planning, Elsevier, vol. 58(C), pages 49-59.
    2. Kenneth F Schulz & Douglas G Altman & David Moher & for the CONSORT Group, 2010. "CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials," PLOS Medicine, Public Library of Science, vol. 7(3), pages 1-7, March.
    3. Myriam Preuß & Mark Nieuwenhuijsen & Sandra Marquez & Marta Cirach & Payam Dadvand & Margarita Triguero-Mas & Christopher Gidlow & Regina Grazuleviciene & Hanneke Kruize & Wilma Zijlema, 2019. "Low Childhood Nature Exposure is Associated with Worse Mental Health in Adulthood," IJERPH, MDPI, vol. 16(10), pages 1-18, May.
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