Effect of Bei App for Fibromyalgia
ConditionFibromyalgia (FM)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidad Autonoma de Madrid
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Mobile App + psychoeducation program
DeviceParticipants 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
BehavioralParticipants will attend 12 weekly group sessions, each lasting one hour, focused on psychoeducation.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Psychoeducation program + mobile appExperimental treatment 1 intervention
Group B: Psychoeducation program aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)2
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
Time frame
Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)Secondary outcomes
1
Pain Catastrophizing
It will be assessed using the Pain Catastrophizing Scale (PCS), which measures the tendency to think catastrophically about pain. The scale consists of 13 items covering three dimensions: rumination, magnification, and helplessness in the face of pain. A Likert scale from 0 to 4 is used, with higher scores indicating greater levels of catastrophizing. The PCS has demonstrated test-retest reliability of 0.84 and adequate internal consistency, with a Cronbach's alpha of 0.79
Time frame
Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)2
Self-Efficacy
it will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ), a self-report questionnaire consisting of 10 items, designed to measure an individual's self-efficacy in managing pain. It assesses the patient's confidence in their ability to perform daily activities despite pain, reflecting their sense of control and autonomy in the face of painful situations. The PSEQ has demonstrated excellent internal consistency, with a Cronbach's alpha of 0.92, and high test-retest reliability with an ICC of 0.90
Time frame
Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)3
Cognitive Function
It will be measured using the Montreal Cognitive Assessment (MoCA), a screening tool designed to quickly assess cognitive function in adults. The MoCA consists of 30 items that evaluate various cognitive domains, including attention, memory, language, visuospatial abilities, and executive functions. The test takes approximately 10-15 minutes to complete and is particularly useful in both clinical and research settings for a rapid and effective evaluation of cognitive functioning. The MoCA has demonstrated good validity and reliability across various populations, with a Cronbach's alpha of 0.77 and an intra-rater correlation of 0.92
Time frame
Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)4
Physical Activity
it will be assessed using the International Physical Activity Questionnaire (IPAQ - short version), which is designed to quickly and efficiently measure physical activity levels in adults. It includes questions that evaluate the frequency and intensity of physical activities performed over the past week, including walking, moderate activity, and vigorous activity
Time frame
Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad Autonoma de Madrid
Lead sponsor
Universidad Rey Juan Carlos
Collaborator
Source ClinicalTrials.gov
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