Fibromyalgia (FM)NCT07090434
Effect of Bei App for Fibromyalgia
A study testing Mobile App + psychoeducation program and Psychoeducation program in people with Fibromyalgia (FM), run by Universidad Autonoma de Madrid.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia (FM)
- What is being tested?
- Mobile App + psychoeducation program and Psychoeducation program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of an mHealth-based Digital Intervention to Support Multimodal Treatment in Patients With Fibromyalgia.
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)
- Being tested
- Mobile App + psychoeducation program, Psychoeducation program
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile App + psychoeducation programDevice
Also called mhealth
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 programBehavioural
Participants will attend 12 weekly group sessions, each lasting one hour, focused on psychoeducation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychoeducation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Secondary outcomes (13)
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
Measured: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
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
Measured: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
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
Measured: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
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
Measured: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Kinesiophobia
it will be assessed using a self-report The Tampa Scale for Kinesiophobia (TSK-11), a self-report questionnaire comprising 11 items. The internal consistency of the TSK is high, with Cronbach's alpha coefficients ranging from 0.74 to 0.93, indicating strong reliability. Test-retest reliability is also good, with correlation coefficients ranging from 0.75 to 0.88
Measured: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Anxiety
it will be assessed using using the Anxiety subscale of the validated Spanish version of the Hospital Anxiety and Depression Scale (HADS), which is divided into two subscales of 7 items each: 1) Depression (HADS-Dep); and 2) Anxiety (HADS-Anx). The subscales of HADS showed internal consistency indices recommended for screening tools. The items in HADS demonstrated a positive correlation with the total score of the anxiety and depression subscales. HADS was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression in both somatic, psychiatric, and primary care patients and in the general population
Measured: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Depression
it will be assessed using the Depression subscale of the validated Spanish version of the Hospital Anxiety and Depression Scale (HADS), which is divided into two subscales of 7 items each: 1) Depression (HADS-Dep); and 2) Anxiety (HADS-Anx). The subscales of HADS showed internal consistency indices recommended for screening tools. The items in HADS demonstrated a positive correlation with the total score of the anxiety and depression subscales. HADS was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression in both somatic, psychiatric, and primary care patients and in the general population
Measured: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Quality of Life EQ-5D
it will be measured with the EuroQoL-5D (EQ-5D) questionnaire, a self-report instrument for assessing health-related quality of life. It comprises three elements: a descriptive scale of 5 factors, a second element composed of a vertical NRS, and a social value index generated by the instrument. The EQ-5D has shown good psychometric properties
Measured: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Digital Literacy
Using 4 dimensions of the eHLQ as a screening tool.
Measured: Baseline (week 0)
App Engagement: Frequency of App Use
Engagement with the app will be assessed by measuring the frequency of app use, defined as the number of distinct access sessions per week.
Unit of Measure: Number of sessions per week
Measured: final of the treatment (week 12) and follow up (24 week)
App Engagement: Session Length
Average duration of each session using the app will be recorded automatically. Unit of Measure: Minutes per session (mean)
Measured: final of the treatment (week 12) and follow up (24 week)
App Engagement: Completion of Logs
Engagement will be measured by the proportion of daily symptom or activity logs completed by participants relative to the number expected during the intervention period.
Unit of Measure: Percentage of logs completed (%)
Measured: final of the treatment (week 12) and follow up (24 week)
App Engagement: Completion of Modules
Engagement with the educational component of the app will be measured by the proportion of completed modules relative to the total number available.
Unit of Measure: Percentage of modules completed (%)
Measured: final of the treatment (week 12) and follow up (24 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start7 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, Raúl Ferrer-Peña, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090434
- Sponsor's protocol ID
- BEI.APP
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and data protection regulations. Although the data will be anonymized, the sensitivity of health-related information from participants with chronic pain conditions requires strict adherence to ethical standards and GDPR compliance. Therefore, no IPD will be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an mHealth-based Digital Intervention to Support Multimodal Treatment in Patients With Fibromyalgia.
- ClinicalTrials.gov ID
- NCT07090434
- Acronym / sponsor ID
- BEI.APP
- Conditions
- Fibromyalgia (FM)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 7 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation program + mobile app | Experimental | Device: Mobile App + psychoeducation programIn 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. |
| Psychoeducation program alone | Active comparator | Behavioral: Psychoeducation programParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile App + psychoeducation programAlso: mhealthParticipants 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 | Device | Psychoeducation program + mobile app |
| Psychoeducation programParticipants will attend 12 weekly group sessions, each lasting one hour, focused on psychoeducation. | Behavioural | Psychoeducation program alone |
Primary outcome
Pain Intensity
Time frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
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
Functional Impact
Time frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
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
13 secondary outcomes
Pain Catastrophizing
Time frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Self-Efficacy
Time frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Cognitive Function
Time frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Physical Activity
Time frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Kinesiophobia
Time frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Anxiety
Time frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Depression
Time frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Quality of Life EQ-5D
Time frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Digital Literacy
Time frame: Baseline (week 0)
App Engagement: Frequency of App Use
Time frame: final of the treatment (week 12) and follow up (24 week)
App Engagement: Session Length
Time frame: final of the treatment (week 12) and follow up (24 week)
App Engagement: Completion of Logs
Time frame: final of the treatment (week 12) and follow up (24 week)
App Engagement: Completion of Modules
Time frame: final of the treatment (week 12) and follow up (24 week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and data protection regulations. Although the data will be anonymized, the sensitivity of health-related information from participants with chronic pain conditions requires strict adherence to ethical standards and GDPR compliance. Therefore, no IPD will be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile App + psychoeducation program and Psychoeducation program in people with Fibromyalgia (FM), run by Universidad Autonoma de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Di Bonaventura (+34655412476, silvia.dibonaventura@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.