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Study protocol for ...
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Gallego, AnaUniv Jyvaskyla, Fac Educ & Psychol, Dept Psychol, Jyvaskyla, Finland.;Univ Jyvaskyla, Sch Wellbeing, JYUWell, Jyvaskyla, Finland.
(författare)
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
- Artikel/kapitelEngelska2024
Förlag, utgivningsår, omfång ...
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Sage Publications,2024
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electronicrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:uu-526381
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-526381URI
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https://doi.org/10.1177/20552076241239177DOI
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Språk:engelska
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Sammanfattning på:engelska
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Klassifikation
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
Anmärkningar
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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 (R)) 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.
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Serrat, MayteVall Hebron Hosp, Unitat Expertesa Sindromes Sensibilitzacio Cent, Serv Reumatol, Barcelona, Spain.
(författare)
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Royuela-Colomer, EstibalizAutonomous Univ Barcelona, Fac Psychol, Dept Clin & Hlth Psychol, Bellaterra, Spain.
(författare)
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Sanabria-Mazo, Juan P.Parc Sanit St Joan Deu, Sant Boi De Llobregat, Spain.;Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Fac Psychol, Barcelona, Spain.;CIBER Epidemiol & Publ Hlth CIBERESP, Madrid, Spain.
(författare)
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Borras, XavierAutonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Fac Psychol, Barcelona, Spain.;CIBER Epidemiol & Publ Hlth CIBERESP, Madrid, Spain.
(författare)
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Esteve, MontserratUniv Barcelona, Dept Biochem & Mol Biomed, Barcelona, Spain.;Univ Barcelona, Inst Biomed IBUB, Barcelona, Spain.;CIBER Physiopathol Obes & Nutr CIBEROBN, Madrid, Spain.
(författare)
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Grasa, MarUniv Barcelona, Dept Biochem & Mol Biomed, Barcelona, Spain.;Univ Barcelona, Inst Biomed IBUB, Barcelona, Spain.;CIBER Physiopathol Obes & Nutr CIBEROBN, Madrid, Spain.
(författare)
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Rosa, AraceliDept Evolut Biol, Unit Zool & Biol Anthropol, Ecol & Environm Sci, Barcelona, Spain.;CIBER Mental Hlth CIBERSAM, Madrid, Spain. Care Policy & Evaluat Ctr CPEC, London Sch Econ & Polit Sci, Dept HealthPolicy, London, England.
(författare)
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Rozadilla-Sacanell, AntoniParc Sanit St Joan Deu, Sant Boi De Llobregat, Spain.;CIBER Epidemiol & Publ Hlth CIBERESP, Madrid, Spain.
(författare)
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Almirall, MiriamVall Hebron Hosp, Unitat Expertesa Sindromes Sensibilitzacio Cent, Serv Reumatol, Barcelona, Spain.
(författare)
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D'Amico, FrancescoCIBER Epidemiol & Publ Hlth CIBERESP, Madrid, Spain.;London Sch Econ & Polit Sci, Dept Hlth Policy, Hlth Policy & Econ, London, England.
(författare)
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Dai, YifeiSwing Therapeut Inc, San Francisco, CA 94111 USA.
(författare)
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Rosenbluth, Michael J.Swing Therapeut Inc, San Francisco, CA 94111 USA.
(författare)
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McCracken, Lance,1962-Uppsala universitet,Institutionen för psykologi(Swepub:uu)lanmc300
(författare)
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Navarrete, JaimeParc Sanit St Joan Deu, Sant Boi De Llobregat, Spain.;CIBER Epidemiol & Publ Hlth CIBERESP, Madrid, Spain.
(författare)
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Feliu-Soler, AlbertAutonomous Univ Barcelona, Fac Psychol, Dept Clin & Hlth Psychol, Bellaterra, Spain.;CIBER Epidemiol & Publ Hlth CIBERESP, Madrid, Spain.
(författare)
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Luciano, Juan, VAutonomous Univ Barcelona, Fac Psychol, Dept Clin & Hlth Psychol, Bellaterra, Spain.;Parc Sanit St Joan Deu, Sant Boi De Llobregat, Spain.;CIBER Epidemiol & Publ Hlth CIBERESP, Madrid, Spain.
(författare)
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Univ Jyvaskyla, Fac Educ & Psychol, Dept Psychol, Jyvaskyla, Finland.;Univ Jyvaskyla, Sch Wellbeing, JYUWell, Jyvaskyla, Finland.Vall Hebron Hosp, Unitat Expertesa Sindromes Sensibilitzacio Cent, Serv Reumatol, Barcelona, Spain.
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:Digital Health: Sage Publications102055-2076
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Till lärosätets databas
- Av författaren/redakt...
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Gallego, Ana
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Serrat, Mayte
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Royuela-Colomer, ...
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Sanabria-Mazo, J ...
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Borras, Xavier
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Esteve, Montserr ...
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visa fler...
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Grasa, Mar
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Rosa, Araceli
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Rozadilla-Sacane ...
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Almirall, Miriam
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D'Amico, Frances ...
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Dai, Yifei
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Rosenbluth, Mich ...
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McCracken, Lance ...
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Navarrete, Jaime
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Feliu-Soler, Alb ...
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Luciano, Juan, V
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visa färre...
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