A recent study (FIBROWALK has supported the effectiveness of a multicomponent treatment based on pain neuroscience education (PNE), exercise therapy (TE), cognitive behavioral therapy (CBT), and mindfulness in patients with fibromyalgia. The aim of the present RCT was: (a) to analyze the effectiveness of a 12-week multicomponent treatment (nature activity therapy for fibromyalgia, NAT-FM) based on the same therapeutic components described above plus nature exposure to maximize improvements in functional impairment (primary outcome), as well as pain, fatigue, anxiety-depression, physical functioning, positive and negative affect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables) compared with treatment as usual (TAU); (b) to preliminarily assess the effects of the nature-based activities included (yoga, Nordic walking, nature photography, and Shinrin Yoku); and (c) to examine whether the positive effects of TAU + NAT-FM on primary and secondary outcomes at post-treatment were mediated through baseline to six-week changes in process variables. A total of 169 FM patients were randomized into two study arms: TAU + NAT-FM vs. TAU alone. Data were collected at baseline, at six-week of treatment, at post-treatment, and throughout treatment by ecological momentary assessment (EMA). Using an intention to treat (ITT) approach, linear mixed-effects models and mediational models through path analyses were computed. Overall, TAU + NAT-FM was significantly more effective than TAU at posttreatment for the primary and secondary outcomes evaluated, as well as for the process variables. Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal. The number needed to treat (NNT) was 3 (95%CI = 1.6–3.2). The nature activities yielded an improvement in affective valence, arousal, dominance, fatigue, pain, stress, and self-efficacy. Kinesiophobia and perceived competence were the mediators that could explain a significant part of the improvements obtained with TAU + NAT-FM treatment. TAU + NAT-FM is an effective co-adjuvant multicomponent treatment for improving FM-related symptoms.

Objective. The purpose of this study was to evaluate the effectiveness of a 12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness—in addition to treatment as usual—compared to treatment as usual only in patients with fibromyalgia (FM). Methods. This randomized controlled trial involved a total of 272 patients who were randomly assigned to either multicomponent treatment (n = 135) or treatment as usual (n = 137). The multicomponent treatment (2-hour weekly sessions) was delivered in groups of 20 participants. Treatment as usual was mainly based on pharmacological treatment according to the predominant symptoms. Data on functional impairment using the Revised Fibromyalgia Impact Questionnaire (FIQR) as the primary outcome were collected as were data for pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, at 12 weeks and, for the multicomponent group only, at 6 and 9 months. An intention-to-treat approach was used to analyze between-group differences. Baseline differences between responders (>20% FIQR reduction) and nonresponders also were analyzed, and the number needed to treat was computed. Results. At posttreatment, significant between-group differences with a large effect size (Cohen d > 0.80) in favor of the multicomponent treatment were found in functional impairment, pain, kinesiophobia, and physical function, whereas differences with a moderate size effect (Cohen d > 0.50 and < 0.80) were found in fatigue, anxiety, and depressive symptoms. Nonresponders scored higher on depressive symptoms than responders at baseline. The number needed to treat was 2 (95% CI = 1.7–2.3). Conclusions. Compared with usual care, there was evidence of short-term (up to 3 months) positive effects of the multicomponent treatment for fibromyalgia. Some methodological shortcomings (eg, absence of follow-up in the control group and monitoring of treatment adherence, potential research allegiance) preclude robust conclusions regarding the proposed multicomponent program.