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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.
Highlights
According to the American College of Rheumatology (ACR), Fibromyalgia (FM) is a chronic disease of unknown etiology, characterised by the presence of generalized musculoskeletal pain and other symptoms, such as fatigue, waking unrefreshed, and cognitive problems [1]
Two strategies will be developed: (a) conduct a sensitivity analysis to determine the impact of adherence to the nature activity therapy for people with Fibromyalgia (NAT-FM) protocol on the observed effects and (b) combine this Randomized controlled trials (RCTs) to the MOTI-NAT programme (Motivational intervention for Nature Activity Therapy) [62], which will have as its main objective the development of specific therapeutic adherence strategies for patients linked to the different protocols of the NAT Project based on the increased motivation to participate in these therapies
This study represents the first attempt for combining pain neuroscience education, exercise therapy, psychological therapy, and exposure to nature in the treatment of fibromyalgia
Summary
According to the American College of Rheumatology (ACR), Fibromyalgia (FM) is a chronic disease of unknown etiology, characterised by the presence of generalized musculoskeletal pain and other symptoms, such as fatigue, waking unrefreshed, and cognitive problems [1]. The prevalence of FM among the general population is estimated to be around 2%. In Spain, a prevalence of 2.4% is reported in the general population over 20 years of age, corresponding to 4.2% for women and 0.2% for men [6]. Due to the variety of complex factors involved in FM, recent years have seen the development and testing of various pharmacological [8] and non-pharmacological [9,10] treatments for management of the condition. The side effects associated with pharmacological treatments, along with their suboptimal clinical effects, have recently prompted the European League against Rheumatism (EULAR) to recommend that these treatments should only be used to control pain and sleep disturbances caused by FM [11]
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