Effect of Bei App for Fibromyalgia

NCT ID: NCT07090434

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-07
• Study Completion Date: 2027-06-30

Brief 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.

Conditions

Fibromyalgia (FM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Psychoeducation program + mobile app

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.

Group Type: EXPERIMENTAL

Mobile App + psychoeducation program

Intervention Type: DEVICE

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 alone

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.

Group Type: ACTIVE_COMPARATOR

Psychoeducation program

Intervention Type: BEHAVIORAL

Participants will attend 12 weekly group sessions, each lasting one hour, focused on psychoeducation.

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

Intervention Type: DEVICE

Psychoeducation program

Participants will attend 12 weekly group sessions, each lasting one hour, focused on psychoeducation.

Intervention Type: BEHAVIORAL

Other Intervention Names

mhealth

Eligibility Criteria

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.
• Individuals with cognitive impairments or technological limitations that prevent the use of the app or participation in digital assessments will also be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: collaborator

Universidad Autonoma de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Raúl Ferrer-Peña

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Silvia Di Bonaventura

Role: CONTACT

silvia.dibonaventura@urjc.es

+34655412476

Other Identifiers

BEI.APP

Identifier Type: -

Identifier Source: org_study_id