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
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
Julkaistu sarjassa
Digital HealthTekijät
Päivämäärä
2024Tekijänoikeudet
© The Author(s) 2024
Objective
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.
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Julkaisija
SAGE PublicationsISSN Hae Julkaisufoorumista
2055-2076Asiasanat
Julkaisu tutkimustietojärjestelmässä
https://converis.jyu.fi/converis/portal/detail/Publication/213326189
Metadata
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Lisätietoja rahoituksesta
This study has been funded by the Institute of Health Carlos III (ISCIII; PI22/00829) and has been co-financed with European Union ERDF funds. The funder had no role in the design of the study protocol; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The project also counts on with the support from Swing Therapeutics, Inc., San Francisco, CA. Juan P. Sanabria-Mazo has a PFIS predoctoral contract from the ISCIII (FI20/00034). Jaime Navarrete has a postdoctoral contract awarded by CIBERESP (CB22/02/00052). Estíbaliz Royuela has a research contract linked to a project awarded by the Ministry of Education and Science (PID2020-117667RA-I00). ...Lisenssi
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