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 Unite...

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Autores: Gallego, Ana, Serrat, Mayte, Royuela-Colomer, Estíbaliz, Sanabria Mazo, Juan P., Borràs, Xavier, Esteve Ràfols, Montserrat, Grasa Martínez, Maria del Mar, Rosa de la Cruz, Araceli, Rozadilla-Sacanell, Antoni, Almirall, Miriam, D'Amico, Francesco, Dai, Yifei, Rosenbluth, Michael J., McCracken, Lance M., Navarrete, Jaime, Feliu-Soler, Albert, Luciano, Juan V.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/215970
Acceso en línea:https://hdl.handle.net/2445/215970
Access Level:acceso abierto
Palabra clave:Fibromiàlgia
Teràpia d'acceptació i compromís
Aplicacions mòbils
Telèfons intel·ligents
Dolor crònic
Fibromyalgia
Acceptance and commitment therapy
Mobile apps
Smartphones
Chronic pain
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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, AnaSerrat, MayteRoyuela-Colomer, EstíbalizSanabria Mazo, Juan P.Borràs, XavierEsteve Ràfols, MontserratGrasa Martínez, Maria del MarRosa de la Cruz, AraceliRozadilla-Sacanell, AntoniAlmirall, MiriamD'Amico, FrancescoDai, YifeiRosenbluth, Michael J.McCracken, Lance M.Navarrete, JaimeFeliu-Soler, AlbertLuciano, Juan V.FibromiàlgiaTeràpia d'acceptació i compromísAplicacions mòbilsTelèfons intel·ligentsDolor crònicFibromyalgiaAcceptance and commitment therapyMobile appsSmartphonesChronic painObjective: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.SAGE Publications2024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/215970Articles publicats en revistes (Biologia Evolutiva, Ecologia i Ciències Ambientals)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1177/20552076241239177Digital Health, 2024, vol. 10, p. 1-12https://doi.org/10.1177/20552076241239177cc-by-nc (c) Gallego Ana et al., 2024http://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/2159702026-05-27T06:46:51Z
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
Fibromiàlgia
Teràpia d'acceptació i compromís
Aplicacions mòbils
Telèfons intel·ligents
Dolor crònic
Fibromyalgia
Acceptance and commitment therapy
Mobile apps
Smartphones
Chronic pain
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
Serrat, Mayte
Royuela-Colomer, Estíbaliz
Sanabria Mazo, Juan P.
Borràs, Xavier
Esteve Ràfols, Montserrat
Grasa Martínez, Maria del Mar
Rosa de la Cruz, Araceli
Rozadilla-Sacanell, Antoni
Almirall, Miriam
D'Amico, Francesco
Dai, Yifei
Rosenbluth, Michael J.
McCracken, Lance M.
Navarrete, Jaime
Feliu-Soler, Albert
Luciano, Juan V.
author Gallego, Ana
author_facet Gallego, Ana
Serrat, Mayte
Royuela-Colomer, Estíbaliz
Sanabria Mazo, Juan P.
Borràs, Xavier
Esteve Ràfols, Montserrat
Grasa Martínez, Maria del Mar
Rosa de la Cruz, Araceli
Rozadilla-Sacanell, Antoni
Almirall, Miriam
D'Amico, Francesco
Dai, Yifei
Rosenbluth, Michael J.
McCracken, Lance M.
Navarrete, Jaime
Feliu-Soler, Albert
Luciano, Juan V.
author_role author
author2 Serrat, Mayte
Royuela-Colomer, Estíbaliz
Sanabria Mazo, Juan P.
Borràs, Xavier
Esteve Ràfols, Montserrat
Grasa Martínez, Maria del Mar
Rosa de la Cruz, Araceli
Rozadilla-Sacanell, Antoni
Almirall, Miriam
D'Amico, Francesco
Dai, Yifei
Rosenbluth, Michael J.
McCracken, Lance M.
Navarrete, Jaime
Feliu-Soler, Albert
Luciano, Juan V.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Fibromiàlgia
Teràpia d'acceptació i compromís
Aplicacions mòbils
Telèfons intel·ligents
Dolor crònic
Fibromyalgia
Acceptance and commitment therapy
Mobile apps
Smartphones
Chronic pain
topic Fibromiàlgia
Teràpia d'acceptació i compromís
Aplicacions mòbils
Telèfons intel·ligents
Dolor crònic
Fibromyalgia
Acceptance and commitment therapy
Mobile apps
Smartphones
Chronic pain
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 2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/215970
url https://hdl.handle.net/2445/215970
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1177/20552076241239177
Digital Health, 2024, vol. 10, p. 1-12
https://doi.org/10.1177/20552076241239177
dc.rights.none.fl_str_mv cc-by-nc (c) Gallego Ana et al., 2024
http://creativecommons.org/licenses/by-nc/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by-nc (c) Gallego Ana et al., 2024
http://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv SAGE Publications
publisher.none.fl_str_mv SAGE Publications
dc.source.none.fl_str_mv Articles publicats en revistes (Biologia Evolutiva, Ecologia i Ciències Ambientals)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869407538103975936
score 15.81155

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