Condition: Fibromyalgia · Sponsor: Fundació Sant Joan de Déu
Introduction: Fibromyalgia (FM) is a prevalent syndrome that lacks curative treatment, imposing high healthcare and societal costs. The SMART-FM-Spain study investigates the effectiveness, physiological effects, and cost-utility of a self-guided digital intervention (STANZA-Spain) based on Acceptance and Commitment Therapy (ACT) for patients with FM. Methodology: Six-month, 3-arm randomized controlled trial (RCT) A total of 360 adult individuals meeting the 2016 American College of Rheumatology (ACR) criteria for FM will be recruited at Vall d'Hebron University Hospital (Barcelona, Spain), The Rheumatology Service of the Parc Sanitari Sant Joan de Déu (Sant Boi, Spain), The San Juan de Dios Hospital of Palma (Palma de Mallorca, Spain) and The San Juan de Dios Hospital of Aljarafe (Sevilla, Spain). They will be randomly allocated to one of the three study arms: Treatment as usual (TAU) plus STANZA-Spain, TAU plus digital symptom tracking (FibroST), or TAU. Participants will be assessed at baseline, post-treatment, and 6 month-follow-up. The primary outcome will be functional impairment, as measured by the FIQR; secondary outcomes will include patient impression of change, depression-anxiety-stress, and pain catastrophizing, among others constructs relevant to FM. Effectiveness and cost-utility analysis from a societal perspective will be computed, whereas ACT-related constructs, such as psychological flexibility, will be assessed to identify processes of change that will be a…
This description comes directly from the study's public registry record.
Jaime Navarrete, PhD · +34936406350 · jaime.navarrete@sjd.es
Paula Ponce López, Msc · +34678758047 · paula.poncel@sjd.es
Always discuss trial participation with your own doctor first.
| Hospital Vall d'Hebrón | Barcelona, Barcelona, Spain | Not Yet Recruiting |
| Parc Sanitari Sant Joan de Déu (PSSJD) | Sant Boi de Llobregat, Barcelona, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05962437