Not Yet RecruitingNot Applicable

Effect of Bei App for Fibromyalgia

70 participantsStarted 2026-01-07

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion Criteria: * Participants will be adults between 18 and 65 years of age with a clinical diagnosis of fibromyalgia according to the 2016 criteria established by the American College of Rheumatology (ACR). * All participants must be actively enrolled in the group sessions offered by the patient association and possess the ability to use a smartphone or tablet compatible with the BEI app. * Informed consent must be provided voluntarily. * Additionally, participants are required to have a minimum level of digital health literacy, operationalized as a score equal to or greater than 2.5 in at least four dimensions of the eHealth Literacy Questionnaire (eHLQ). Exclusion Criteria: * Participants will be excluded if they present with severe or unstable psychiatric disorders, such as schizophrenia or uncontrolled major depression. * Other exclusion criteria include medical comorbidities that contraindicate physical activity, current pregnancy, or concurrent participation in another digital health program or the use of similar therapeutic applications. * Individuals with cognitive impairments or technological limitations that prevent the use of the app or participation in digital assessments will also be excluded.

What they're measuring

Pain Intensity

Timeframe: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)

Functional Impact

Timeframe: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)

Trial details

NCT IDNCT07090434

SponsorUniversidad Autonoma de Madrid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Silvia Di Bonaventura

+34655412476 silvia.dibonaventura@urjc.es