Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia (SMART-FM-SP)
Fibromyalgia
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
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 90 days. Unable to use a smartphone. Exclusion criteria for biomarkers substudy (50% of patients in each study arm): Comorbid rheumatologic disorders such as lupus. History of fever (> 38ºC), or infection within the last 2 weeks. Recent vaccination within the last 4 weeks. Needle phobia. Consumption of more than 8 units of caffeine per day. Smoking more than 5 cigarettes per day. Having hair length less than 3 cm.
Sites / Locations
- Parc Sanitari Sant Joan de Déu (PSSJD)
- Hospital Vall d'Hebrón
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
STANZA-Spain
FibroST-Spain
Treatment as Usual (TAU)
Digital Acceptance and Commitment Terapy (ACT). It consists of 41 structured ACT lessons, incorporating mindfulness practices and daily activities to facilitate behavior change and promote gradual pacing of daily activities and exercise. The core content was designed to be completed within 8 weeks, with a 4-week maintenance period thereafter to strengthen skills.
A digital active control intervention is implemented to control for study engagement, expectations, and healthcare provider interaction biases. Components of this active comparator include daily symptom and function tracking (Daily Symptom Tracker), symptom and function monitoring, and access to health education articles about fibromyalgia.
Usual care is mainly carried out by general practitioners and rheumatologists through regular consultations. Clinicians prescribe medications and provide some counselling.