Effect of Bei App for Fibromyalgia

NCT07090434 | Not Yet Recruiting

• 1 other identifier: BEI.APP
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  Pain intensity will be measured using a 100 mm Numeric Rating Scale (NRS), where 0 represents "no pain" and 100 represents the "worst pain imaginable." Participants will mark a point on the line that best reflected the pain they were experiencing at the time of measurement. Higher scores indicated higher levels of pain, and the administration required less than one minute

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

• Functional Impact

  It will be measured using the Revised Fibromyalgia Impact Questionnaire (FIQR), a tool designed to assess the impact of fibromyalgia on patients' daily lives. The FIQR consists of 21 items that evaluate various dimensions, including physical functioning, symptom severity, general health, and pain perception. Items are scored on a scale from 0 to 10, with higher scores indicating a greater impact of the disease. It has demonstrated high internal consistency, with a Cronbach's alpha ranging from 0.91 to 0.95

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

Secondary Outcomes (13)

• Pain Catastrophizing

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

• Self-Efficacy

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

• Cognitive Function

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

• Physical Activity

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

• Kinesiophobia

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

Study Arms (2)

Psychoeducation program + mobile app

EXPERIMENTAL

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.

Device: Mobile App + psychoeducation program

Psychoeducation program alone

ACTIVE COMPARATOR

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.

Behavioral: Psychoeducation program

Interventions

Mobile App + psychoeducation program 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

Also known as: mhealth

Psychoeducation program + mobile app

Psychoeducation program BEHAVIORAL

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

Psychoeducation program alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead
• Universidad Rey Juan Carlos: collaborator

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Silvia Di Bonaventura

CONTACT

+34655412476; silvia.dibonaventura@urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 29, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share