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

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, 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

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.

Keywords: cognitive behavioural therapy; ecological momentary assessment; exercise therapy; fibromyalgia; multicomponent treatment; nature exposure; pain neuroscience education; randomized controlled trial; study protocol.

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Flow chart of the randomized controlled trial (RCT).

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