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

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.

Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial

“…A detailed description of the study protocol is provided elsewhere [ 28 ]. A 12-week RCT was conducted in which the study participants were randomly allocated to 2 arms (using computer generated numbers): (a) TAU (control group) and (b) TAU + NAT-FM (active group).…”

“…The procedure for recruiting the participants can be found in the study protocol [ 28 ]. In brief, all patients were consecutively screened by the physical therapist (M.S.)…”

“…The TAU + NAT-FM protocol integrates the FIBROWALK protocol [ 27 ], replacing the exercise therapy described there for activities carried out in nature such as Yoga, Nordic walking, photography, and Shinrin Yoku. Table 1 and Table 2 provide an updated outline of the TAU + NAT-FM program described elsewhere [ 27 , 28 ].…”

“…At the same time, therapeutic programs based on activities in nature have shown promise for improving mental health [ 28 , 29 , 30 , 31 ] in various clinical populations [ 32 , 33 ]. A growing number of studies suggest that exposure to nature directly produces effects in the affective (positive and negative emotions, and stress) and cognitive (attention, memory, etc.)…”

Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

“…In this scenario, non-pharmacological treatments based on psychoeducation, physical exercise, mindfulness, and cognitive-behavior therapy (CBT) have proven their effectiveness for improving mental health, increasing physical function, decreasing symptoms, and strengthening the acceptance of FM, obtaining small to medium effect sizes [ 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 ]. Furthermore, multicomponent treatments integrating some of these practices have been considered the gold-standard for managing FM [ 6 , 12 ].…”