Evaluating the Effectiveness of a Digital mHealth Intervention (Bei App) to Support Multimodal Treatment in Patients with Fibromyalgia: A Randomized Controlled Trial Protocol
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Background
Fibromyalgia (FM) is a complex, chronic condition characterized by widespread musculoskeletal pain, cognitive dysfunction, fatigue, and emotional comorbidities such as anxiety and depression. These symptoms severely impact daily functioning and quality of life. Although non-pharmacological strategies—such as therapeutic exercise and patient education—are recommended as first-line treatments, their implementation outside the clinical setting remains a challenge due to low adherence and lack of continuity.
Objective
To evaluate the effectiveness of a digital health intervention—BEI app—as a complement to usual care in improving clinical and functional outcomes among patients with fibromyalgia.
Methods
This is a randomized controlled trial (RCT) with two parallel arms (1:1 allocation). A total of 70 adult participants with fibromyalgia (diagnosed per ACR 2016 criteria) will be recruited through a patient association in Madrid, Spain. The control group will receive 12 weeks of standard, in-person treatment consisting of group-based education and physical activity. The experimental group will receive the same in- person program plus daily access to the BEI mobile application, which includes educational modules, physical and cognitive training, symptom tracking, and personalized feedback. Outcomes will be assessed at baseline, week 6 (mid- intervention), week 12 (post-intervention), and week 24 (follow-up). Primary outcomes include pain intensity (VAS) and functional impact (FIQR). Secondary outcomes include catastrophizing, self-efficacy, cognitive function, physical activity, anxiety, depression, quality of life, app engagement, and satisfaction.
Expected results
The results of this trial will provide evidence regarding the potential of mHealth tools to enhance adherence, self-efficacy, and functional outcomes in individuals with fibromyalgia.
Trial registration
NCT07090434 ( ClinicalTrials.gov )
