A1 Alkuperäisartikkeli tieteellisessä aikakauslehdessä
Study protocol for a three-arm randomized controlled trial investigating the effectiveness, cost-utility, and physiological effects of a fully self-guided digital Acceptance and Commitment Therapy for Spanish patients with fibromyalgia (2024)
Gallego, A., Serrat, M., Royuela-Colomer, E., Sanabria-Mazo, J. P., Borràs, X., Esteve, M., Grasa, M., Rosa, A., Rozadilla-Sacanell, A., Almirall, M., D’Amico, F., Dai, Y., Rosenbluth, M. J., McCracken, L. M., Navarrete, J., Feliu-Soler, A., & Luciano, J. V. (2024). Study protocol for a three-arm randomized controlled trial investigating the effectiveness, cost-utility, and physiological effects of a fully self-guided digital Acceptance and Commitment Therapy for Spanish patients with fibromyalgia. Digital Health, 10. https://doi.org/10.1177/20552076241239177
JYU-tekijät tai -toimittajat
Julkaisun tiedot
Julkaisun kaikki tekijät tai toimittajat: Gallego, Ana; Serrat, Mayte; Royuela-Colomer, Estíbaliz; Sanabria-Mazo, Juan P.; Borràs, Xavier; Esteve, Montserrat; Grasa, Mar; Rosa, Araceli; Rozadilla-Sacanell, Antoni; Almirall, Miriam; et al.
Lehti tai sarja: Digital Health
eISSN: 2055-2076
Julkaisuvuosi: 2024
Ilmestymispäivä: 27.03.2024
Volyymi: 10
Kustantaja: SAGE Publications
Julkaisumaa: Britannia
Julkaisun kieli: englanti
DOI: https://doi.org/10.1177/20552076241239177
Julkaisun avoin saatavuus: Avoimesti saatavilla
Julkaisukanavan avoin saatavuus: Kokonaan avoin julkaisukanava
Julkaisu on rinnakkaistallennettu (JYX): https://jyx.jyu.fi/handle/123456789/94474
Julkaisu on rinnakkaistallennettu: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10976514/
Tiivistelmä
Fibromyalgia (FM) is a prevalent pain syndrome with significant healthcare and societal costs. The aim of the SMART-FM-SP study is to determine the effectiveness, cost-utility, and physiological effects in patients with FM of a digital intervention (STANZA®) currently marketed in the United States, which delivers smartphone-based, fully self-guided Acceptance and Commitment Therapy (Digital ACT) for treating FM-related symptoms.
Methods
A single-site, parallel-group, superiority, randomized controlled trial (RCT) will be conducted, including a total of 360 adults diagnosed with FM. Individuals will be randomly allocated (1:1:1) to treatment as usual (TAU), to TAU plus 12 weeks of treatment with Digital ACT, or to TAU plus 12 weeks of treatment with digital symptom tracking (i.e. FibroST). Participants will be assessed at baseline, post-treatment, and 6-month follow-up. An intention-to-treat analysis using linear mixed models will be computed to analyze the effects of Digital ACT on functional impairment (primary outcome), as measured by the Fibromyalgia Impact Questionnaire Revised at 6 months from the inception of the treatment. Secondary outcomes include impression of change, symptoms of distress, pain catastrophising, quality of life, cost-utility, and selected biomarkers (cortisol and cortisone, immune-inflammatory markers, and FKBP5 gene polymorphisms). The role of ACT-related processes of change will be tested with path analyses.
Conclusions
This study is the first RCT that tests Digital ACT for Spanish patients with FM. Results will be important not only for patients and clinicians, but also for policy makers by examining the cost-utility of the app in a public healthcare context.
YSO-asiasanat: fibromyalgia; krooninen kipu; hyväksymis- ja omistautumisterapia; hoitomenetelmät; mobiilisovellukset; älypuhelimet; biomarkkerit; kustannustehokkuus; satunnaistetut vertailukokeet
applications; smartphone
Liittyvät organisaatiot
OKM-raportointi: Kyllä
Alustava JUFO-taso: 1
