An interventional study of Mobile App + psychoeducation program and Psychoeducation program in Fibromyalgia (FM), sponsored by Universidad Autonoma de Madrid. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Universidad Autonoma de Madrid · Not applicable, Interventional, and Supportive care
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Universidad Autonoma de Madrid is the lead sponsor of 51 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Participants will attend 12 weekly group sessions, each lasting one hour, focused on psychoeducation.
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)
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)
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)
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)
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)
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)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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 (%)
Time frame: 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 (%)
Time frame: final of the treatment (week 12) and follow up (24 week)
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Universidad Autonoma de Madrid