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

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 Unit...

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Autores: Gallego, Ana|||0000-0002-8060-2495, Serrat López, Mayte|||0000-0002-5591-9407, Royuela-Colomer, Estíbaliz|||0000-0001-9912-9610, Sanabria-Mazo, Juan P.|||0000-0003-1688-435X, Borràs, Xavier|||0000-0003-3972-1385, Esteve, Montserrat|||0000-0003-2128-7859, Grasa, Mar, Rosa de la Cruz, Araceli|||0000-0001-6935-3785, Rozadilla-Sacanell, Antoni, Almirall, Míriam|||0000-0002-4874-8013, D'Amico, Francesco|||0000-0001-7995-826X, Dai, Yifei, Rosenbluth, Michael, McCracken, Lance M.|||0000-0002-9734-0153, Navarrete Hidalgo, Jaime|||0000-0002-9482-4822, Feliu-Soler, Albert|||0000-0003-2810-7670, Luciano, Juan Vicente|||0000-0003-0750-1599
Formato: artículo
Fecha de publicación:2024
País:España
Recursos:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:293354
Acesso em linha:https://ddd.uab.cat/record/293354
https://dx.doi.org/urn:doi:10.1177/20552076241239177
Access Level:acceso abierto
Palavra-chave:Acceptance and Commitment Therapy
Biomarkers
Chronic pain
Cost-utility
Fibromyalgia
Mhealth technology
Mobile applications
Smartphone
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spelling 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 fibromyalgiaGallego, Ana|||0000-0002-8060-2495Serrat López, Mayte|||0000-0002-5591-9407Royuela-Colomer, Estíbaliz|||0000-0001-9912-9610Sanabria-Mazo, Juan P.|||0000-0003-1688-435XBorràs, Xavier|||0000-0003-3972-1385Esteve, Montserrat|||0000-0003-2128-7859Grasa, MarRosa de la Cruz, Araceli|||0000-0001-6935-3785Rozadilla-Sacanell, AntoniAlmirall, Míriam|||0000-0002-4874-8013D'Amico, Francesco|||0000-0001-7995-826XDai, YifeiRosenbluth, MichaelMcCracken, Lance M.|||0000-0002-9734-0153Navarrete Hidalgo, Jaime|||0000-0002-9482-4822Feliu-Soler, Albert|||0000-0003-2810-7670Luciano, Juan Vicente|||0000-0003-0750-1599Acceptance and Commitment TherapyBiomarkersChronic painCost-utilityFibromyalgiaMhealth technologyMobile applicationsSmartphoneObjective: 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. 22024-01-0120242024-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/293354https://dx.doi.org/urn:doi:10.1177/20552076241239177reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengInstituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI22/00829open accesshttp://purl.org/coar/access_right/c_abf2Aquesta url de drets no existeix a la base de dades.https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2933542026-06-06T12:50:31Z
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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|||0000-0002-8060-2495
Acceptance and Commitment Therapy
Biomarkers
Chronic pain
Cost-utility
Fibromyalgia
Mhealth technology
Mobile applications
Smartphone
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv Gallego, Ana|||0000-0002-8060-2495
Serrat López, Mayte|||0000-0002-5591-9407
Royuela-Colomer, Estíbaliz|||0000-0001-9912-9610
Sanabria-Mazo, Juan P.|||0000-0003-1688-435X
Borràs, Xavier|||0000-0003-3972-1385
Esteve, Montserrat|||0000-0003-2128-7859
Grasa, Mar
Rosa de la Cruz, Araceli|||0000-0001-6935-3785
Rozadilla-Sacanell, Antoni
Almirall, Míriam|||0000-0002-4874-8013
D'Amico, Francesco|||0000-0001-7995-826X
Dai, Yifei
Rosenbluth, Michael
McCracken, Lance M.|||0000-0002-9734-0153
Navarrete Hidalgo, Jaime|||0000-0002-9482-4822
Feliu-Soler, Albert|||0000-0003-2810-7670
Luciano, Juan Vicente|||0000-0003-0750-1599
author Gallego, Ana|||0000-0002-8060-2495
author_facet Gallego, Ana|||0000-0002-8060-2495
Serrat López, Mayte|||0000-0002-5591-9407
Royuela-Colomer, Estíbaliz|||0000-0001-9912-9610
Sanabria-Mazo, Juan P.|||0000-0003-1688-435X
Borràs, Xavier|||0000-0003-3972-1385
Esteve, Montserrat|||0000-0003-2128-7859
Grasa, Mar
Rosa de la Cruz, Araceli|||0000-0001-6935-3785
Rozadilla-Sacanell, Antoni
Almirall, Míriam|||0000-0002-4874-8013
D'Amico, Francesco|||0000-0001-7995-826X
Dai, Yifei
Rosenbluth, Michael
McCracken, Lance M.|||0000-0002-9734-0153
Navarrete Hidalgo, Jaime|||0000-0002-9482-4822
Feliu-Soler, Albert|||0000-0003-2810-7670
Luciano, Juan Vicente|||0000-0003-0750-1599
author_role author
author2 Serrat López, Mayte|||0000-0002-5591-9407
Royuela-Colomer, Estíbaliz|||0000-0001-9912-9610
Sanabria-Mazo, Juan P.|||0000-0003-1688-435X
Borràs, Xavier|||0000-0003-3972-1385
Esteve, Montserrat|||0000-0003-2128-7859
Grasa, Mar
Rosa de la Cruz, Araceli|||0000-0001-6935-3785
Rozadilla-Sacanell, Antoni
Almirall, Míriam|||0000-0002-4874-8013
D'Amico, Francesco|||0000-0001-7995-826X
Dai, Yifei
Rosenbluth, Michael
McCracken, Lance M.|||0000-0002-9734-0153
Navarrete Hidalgo, Jaime|||0000-0002-9482-4822
Feliu-Soler, Albert|||0000-0003-2810-7670
Luciano, Juan Vicente|||0000-0003-0750-1599
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Acceptance and Commitment Therapy
Biomarkers
Chronic pain
Cost-utility
Fibromyalgia
Mhealth technology
Mobile applications
Smartphone
topic Acceptance and Commitment Therapy
Biomarkers
Chronic pain
Cost-utility
Fibromyalgia
Mhealth technology
Mobile applications
Smartphone
description 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.
publishDate 2024
dc.date.none.fl_str_mv 2
2024-01-01
2024
2024-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/293354
https://dx.doi.org/urn:doi:10.1177/20552076241239177
url https://ddd.uab.cat/record/293354
https://dx.doi.org/urn:doi:10.1177/20552076241239177
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.relation.none.fl_str_mv Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI22/00829
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Aquesta url de drets no existeix a la base de dades.
https://creativecommons.org/licenses/by-nc/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Aquesta url de drets no existeix a la base de dades.
https://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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