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, Ana (University of Jyväskylä. Department of Psychology)
Serrat, Mayte (Hospital Universitari Vall d'Hebron)
Royuela-Colomer, Estíbaliz (Universitat Autònoma de Barcelona. Departament de Psicologia Clínica i de la Salut)
Sanabria-Mazo, Juan P.. (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació)
Borràs, Xavier (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació)
Esteve, Montserrat (Universitat de Barcelona. Departament de Bioquímica i Biomedicina Molecular)
Grasa, Mar (Universitat de Barcelona. Departament de Bioquímica i Biomedicina Molecular)
Rosa, Araceli (Universitat de Barcelona. Departament de Biologia Evolutiva, Ecologia i Ciències Ambientals)
Rozadilla-Sacanell, Antoni (Parc Sanitari Sant Joan de Déu)
Almirall, Míriam (Hospital Universitari Vall d'Hebron)
D'Amico, Francesco (Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública)
Dai, Yifei (Uppsala University. Department of Psychology)
Rosenbluth, Michael (Swing Therapeutics)
McCracken, Lance M (Uppsala Universitet. Department of Psychology)
Navarrete Hidalgo, Jaime (Parc Sanitari Sant Joan de Déu)
Feliu-Soler, Albert (Universitat Autònoma de Barcelona. Departament de Psicologia Clínica i de la Salut)
Luciano, Juan Vicente (Universitat Autònoma de Barcelona. Departament de Psicologia Clínica i de la Salut)

Fecha:	2024
Descripción:	12 pàg.
Resumen:	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.
Ayudas:	Instituto de Salud Carlos III PI22/00829
Nota:	Altres ajuts: This study has been co-financed with European Union ERDF funds. 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).
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Acceptance and Commitment Therapy ; Biomarkers ; Chronic pain ; Cost-utility ; Fibromyalgia ; Mhealth technology ; Mobile applications ; Smartphone
Publicado en:	Digital Health, Vol. 10 (Jan-Dec. 2024) , ISSN 2055-2076

DOI: 10.1177/20552076241239177
PMID: 38550263

12 p, 645.4 KB

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