Self-guided ACT-based app for fibromyalgia management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a six‑month, three‑arm randomized trial enrolling adults with fibromyalgia to compare TAU alone, TAU plus the STANZA-Spain ACT-based app, and TAU plus a FibroST symptom-tracking app. The study will assess clinical outcomes, inflammatory biomarkers, and cost-utility from both healthcare and societal perspectives. Participants will be recruited at multiple hospitals in Spain and must own a compatible smartphone and speak Spanish. An embedded biomarker sub-study will evaluate potential predictors of response and will involve a subset of participants. The trial is led by Fundació Sant Joan de Déu with collaborators and aims to clarify whether digital ACT can add value to standard fibromyalgia care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Fibromyalgia diagnosis according to the 2016 ACR criteria
* Fibromyalgia Impact Questionnaire Revised (FIQR) total score within the range of 35-80 at baseline.
* Willing to maintain their current pain treatment throughout the study.
* Having a smartphone (iOS 12 or higher or Android OS 8 or higher).
* Proficient understanding of Spanish.

Exclusion Criteria:

* Presence of cognitive impairment according to clinical records.
* Diagnosis of severe medical or mental disorders such as cancer, psychotic disorder, and drug abuse according to medical records.
* Patients at risk of suicide.
* Being pregnant or planning a pregnancy during the study period, or currently breastfeeding.
* Participation in other clinical trials during the study or within the previous 12 months.
* Unable to use a smartphone.

Exclusion criteria for biomarkers substudy (30-50 patients in each study arm):

* Male sex
* Comorbid rheumatologic disorders such as lupus or severe organ dysfunction.
* History of fever (\> 38ºC) or infection within the last 2 weeks.
* Vaccination within the last 4 weeks.
* Recent physical trauma
* Needle phobia.
* Consumption of more than 8 units of caffeine per day.
* Smoking more than 5 cigarettes per day.
* Current use of oral or topical corticosteroids.
* Current use of anti-cytokine biologic medications.
* Current use of oral contraceptives.

Where it's running

• Parc Sanitari Sant Joan de Déu (PSSJD)
  Sant Boi de Llobregat, Barcelona, Spain Recruiting
• Hospital Vall d'Hebrón
  Barcelona, Barcelona, Spain Not yet recruiting

Study contacts

• Principal investigator: Juan V Luciano, PhD — Universitat Autònoma de Barcelona (UAB) & FSJD
• Study coordinator: Jaime Navarrete, PhD
• Email: jaime.navarrete@sjd.es
• Phone: +34936406350

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.