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FibromyalgiaNCT07424534

Predictive Models on Psychosocial Profile, Fatigue and Sleep Quality

An observational study of Fibromyalgia, run by University of Castilla-La Mancha at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The primary goal of this research project is to develop different prediction models in fibromyalgia disease through the application of machine learning techniques and to assess the explainability of the results. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Fibromyalgia
How many people
150 participants
Where
1 siteSpain
Study dates
24 Feb 2026to 30 Nov 2026
Phase
Observational
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

Study population: The study population will consist of adult volunteers diagnosed with fibromyalgia who meet the eligibility criteria and provide written informed consent to participate in the study. Participants will be recruited from a primary care center within the Spanish public healthcare system.

Who may be able to join

  • Age between 18 and 65 years.
  • Fullfilled the 2010 American Collegue of Rheumathology criteria for fibromyalgia.
  • Understanding of spoken and written Spanish.

Who cannot join

  • Diagnosed psychiatric pathology.
  • Rheumatic pathology not medically controlled.
  • Neurological pathologies that make evaluations difficult.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rafael Velasco Velasco, Mr. contact

+34954786735

Rafael.Velasco@uclm.es

Rubén Arroyo Fernández, Dr. contact

+34925803600 ext. 86589

Ruben.Arroyo@uclm.es

Spain1 site
  • Rafael Velasco Velasco

    Seville, Seville, 41008

    Rafael Velasco Velasco, Mr., +34954786735, Rafael.Velasco@uclm.es

Other trials in Spain

About this study

Official title: Development of Artificial Intelligence-Based Predictive Models to Analyze the Impact of Psychosocial Profile, Fatigue, and Sleep Quality on Disease Severity in Patients With Fibromyalgia

The primary goal of this research project is to develop different prediction models in fibromyalgia disease through the application of machine learning techniques and to assess the explainability of the results. As specific objective the research project intends to evaluate the influence of psychosocial variables, fatigue, and sleep quality on the prediction of disease severity in patients with fibromyalgia using an artificial intelligence-based model.

Read the detailed description

Fibromyalgia (FM) is a condition characterized by chronic musculoskeletal pain, the pathophysiology of which remains unclear. In addition, this disorder is frequently associated with sleep disturbances, pronounced fatigue, morning stiffness, poor quality of life, cognitive alterations (primarily memory-related problems), and psychological disturbances, including depression, anxiety, and stress.

FM is significantly more prevalent in women, with an estimated female-to-male ratio of approximately 3:1. Its prevalence in the adult population is estimated at 2-3%, increasing with age and peaking between 45 and 65 years. The socioeconomic and healthcare burden of this condition is substantial, as FM is associated with high rates of medical consultations, unemployment, work disability, and the need for disability-related financial support.

FM has been linked to higher levels of negative affect, defined as a general state of distress encompassing aversive emotions such as sadness, fear, anger, and guilt. Patients with FM commonly exhibit elevated levels of anxiety, depression, pain catastrophizing, and stress, which are associated with worsening of symptoms, including cognitive impairments.

In recent years, machine learning, data mining, and artificial intelligence (AI) techniques have been successfully applied to the development of computer-aided diagnosis (CAD) systems for the identification of complex health conditions, achieving good levels of accuracy and efficiency by recognizing potentially meaningful patterns in health-related data. Accordingly, these technologies provide powerful tools for multivariable data analysis, enabling model-based predictions and offering a clear advantage in risk assessment across a wide range of diseases. In addition, these approaches not only support the development of clinical predictive models but also enhance clinicians' ability to interpret and apply their results in practice.

Explainable machine learning models allow clinical experts to make data-driven decisions and to deliver personalized treatments while maintaining a high standard of care. These models fall within the field of explainable artificial intelligence (XAI), which aims to develop interpretable models that preserve high predictive accuracy while improving the transparency, understanding, and trustworthiness of model outputs.

A previous publication by our research group demonstrated, using machine learning models, a strong association between mental health factors-particularly anxiety and depression-and fibromyalgia severity, with a greater influence than pain intensity itself. Other prevalent symptoms of fibromyalgia, such as fatigue and sleep quality disturbances, are also considered by patients to be major contributors to reduced quality of life, often perceived as more impactful than pain.

Accordingly, the present study aims to develop predictive models of fibromyalgia severity using machine learning and explainable artificial intelligence techniques, incorporating fatigue and sleep quality as novel variables in the analysis.

Understanding the individual and combined relevance of these psychosocial components in determining patients' clinical status may contribute to improved disease management and more personalized treatment strategies, ultimately enhancing the quality of care.

Conditions
Fibromyalgia
Medical subject headings
Fibromyalgia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease severity

    For this purpose, the Spanish validated version of the Fibromyalgia Impact Questionnaire (FIQ) will be used. The questionnaire comprises several components assessing physical, psychological, and social status, as well as overall well-being. It consists of 10 items scored on 0-10 scales, yielding a total score ranging from 0 to 100, with higher scores indicating greater disease impact and poorer quality of life.

    Measured: Baseline

Secondary outcomes (6)
  1. Sleep quality

    Sleep quality will be assessed using the Spanish validated version of the Medical Outcomes Study Sleep Scale (MOS-SS). This instrument consists of 12 items evaluating six sleep domains: sleep disturbance (ability to initiate and maintain sleep), sleep adequacy (sufficiency of sleep to feel rested), sleep quantity (number of hours of sleep), somnolence (daytime sleepiness), snoring, and shortness of breath or headache. A sleep problems index can be derived on a 0-100 scale, with higher scores indicating greater sleep-related problems.

    Measured: Baseline

  2. Fatigue

    Fatigue severity will be assessed using the Spanish adaptation of the Multidimensional Fatigue Inventory (MFI). This is a self-administered questionnaire consisting of 20 items. It comprises five subscales that analytically assess general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. The total score ranges from 0 to 100, with higher scores indicating greater fatigue severity.

    Measured: Baseline

  3. Pain intensity

    It will be measured with a visual analog scale (VAS) of 100 millimeters in length. The subject has to indicate the level of pain he feels, being 0 the absence of pain and 100 the maximum imaginable.

    Measured: Baseline

  4. Depression

    Depressive symptoms will be assessed using the Spanish adaptation of the Beck Depression Inventory-II (BDI-II). This instrument consists of 21 items designed to measure affective and cognitive status, as well as the signs and symptoms of depression experienced over the preceding two weeks. Total scores range from 0 to 63, where higher scores indicate greater severity.

    Measured: Baseline

  5. Pain catastrophizing

    The Spanish validated version of the Pain Catastrophizing Scale (PCS) will be administered. The PCS consists of 13 items assessing catastrophic cognitive-emotional processes related to pain and encompasses the three main dimensions of catastrophizing: rumination (persistent concern and inability to inhibit pain-related thoughts), magnification (exaggeration of the unpleasantness of pain and expectations of negative consequences), and helplessness (perceived inability to cope with painful situations). Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is calculated by summing the responses to all 13 items, with higher scores indicating greater levels of pain catastrophizing.

    Measured: Baseline

  6. Anxiety

    Anxiety will be assessed using the Spanish validated version of the State Anxiety Scale (STAI-S) of the State-Trait Anxiety Inventory (STAI). It consists of 20 items scored on a Likert-type scale from 0 to 3. The score ranges from 0 to 60 points, with higher scores indicating worse anxiety levels.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2026
  2. Study start24 Feb 2026 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07424534
Sponsor's protocol ID
FibroIA
Status last verified
Mar 2026
First submitted
13 Feb 2026
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia, run by University of Castilla-La Mancha at 1 site in Spain.

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 3 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 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Rafael Velasco Velasco, Mr. (+34954786735, Rafael.Velasco@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease severity (time frame: Baseline). 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 5 Mar 2026.

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