Effect of Bei App for Fibromyalgia

Universidad Autonoma de Madrid

Status: Not yet enrolling

Conditions: Fibromyalgia (FM)

Treatments: Behavioral: Psychoeducation program; Device: Mobile App + psychoeducation program

Study type: Interventional

Funder types: Other

Identifiers

NCT07090434

BEI.APP

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Psychoeducation program + mobile app

Experimental group

Description:

In addition to the psychoeducation program (12 weekly group sessions, each lasting one hour), 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 Bei integrates adaptive feedback based on usage patterns, providing a more personalized experience to support long-term adherence.

Treatment:

Device: Mobile App + psychoeducation program

Psychoeducation program alone

Active Comparator group

Description:

Participants will attend 12 weekly group sessions, each lasting one hour, focused on psychoeducation. Sessions are delivered in person by trained professionals (physiotherapists and psychologists) from the association.

Treatment:

Behavioral: Psychoeducation program