Clinical Research Directory
Browse clinical research sites, groups, and studies.
Effect of Bei App for Fibromyalgia
Sponsor: Universidad Autonoma de Madrid
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.
Official title: Effect of an mHealth-based Digital Intervention to Support Multimodal Treatment in Patients With Fibromyalgia.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-01-07
Completion Date
2027-06-30
Last Updated
2025-07-29
Healthy Volunteers
No
Conditions
Interventions
Mobile App + psychoeducation program
Participants will attend 12 weekly group sessions, each lasting one hour, focused on psychoeducation. In addition to that, participants will receive access to the BEI mobile app, designed to reinforce education and exercise strategies outside clinical sessions. Participants will be instructed to use the app daily, guided by a to-do list including: * 1 educational module (interactive format) + 3 questions self-exam * 1 physical activity (video-guided, adapted by fatigue and pain level) * 1 gamified cognitive task (for memory, attention, speed processing and/or executive function) * Daily mood and symptom check-in
Psychoeducation program
Participants will attend 12 weekly group sessions, each lasting one hour, focused on psychoeducation.