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Study protocol for ...
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
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- Gallego, Ana (author)
- Univ Jyvaskyla, Fac Educ & Psychol, Dept Psychol, Jyvaskyla, Finland.;Univ Jyvaskyla, Sch Wellbeing, JYUWell, Jyvaskyla, Finland.
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- Serrat, Mayte (author)
- Vall Hebron Hosp, Unitat Expertesa Sindromes Sensibilitzacio Cent, Serv Reumatol, Barcelona, Spain.
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- Royuela-Colomer, Estibaliz (author)
- Autonomous Univ Barcelona, Fac Psychol, Dept Clin & Hlth Psychol, Bellaterra, Spain.
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- Sanabria-Mazo, Juan P. (author)
- 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.
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- Borras, Xavier (author)
- Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Fac Psychol, Barcelona, Spain.;CIBER Epidemiol & Publ Hlth CIBERESP, Madrid, Spain.
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- Esteve, Montserrat (author)
- Univ Barcelona, Dept Biochem & Mol Biomed, Barcelona, Spain.;Univ Barcelona, Inst Biomed IBUB, Barcelona, Spain.;CIBER Physiopathol Obes & Nutr CIBEROBN, Madrid, Spain.
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- Grasa, Mar (author)
- Univ Barcelona, Dept Biochem & Mol Biomed, Barcelona, Spain.;Univ Barcelona, Inst Biomed IBUB, Barcelona, Spain.;CIBER Physiopathol Obes & Nutr CIBEROBN, Madrid, Spain.
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- Rosa, Araceli (author)
- Dept 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.
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- Rozadilla-Sacanell, Antoni (author)
- Parc Sanit St Joan Deu, Sant Boi De Llobregat, Spain.;CIBER Epidemiol & Publ Hlth CIBERESP, Madrid, Spain.
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- Almirall, Miriam (author)
- Vall Hebron Hosp, Unitat Expertesa Sindromes Sensibilitzacio Cent, Serv Reumatol, Barcelona, Spain.
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- D'Amico, Francesco (author)
- CIBER Epidemiol & Publ Hlth CIBERESP, Madrid, Spain.;London Sch Econ & Polit Sci, Dept Hlth Policy, Hlth Policy & Econ, London, England.
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- Dai, Yifei (author)
- Swing Therapeut Inc, San Francisco, CA 94111 USA.
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- Rosenbluth, Michael J. (author)
- Swing Therapeut Inc, San Francisco, CA 94111 USA.
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- McCracken, Lance, 1962- (author)
- Uppsala universitet,Institutionen för psykologi
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- Navarrete, Jaime (author)
- Parc Sanit St Joan Deu, Sant Boi De Llobregat, Spain.;CIBER Epidemiol & Publ Hlth CIBERESP, Madrid, Spain.
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- Feliu-Soler, Albert (author)
- Autonomous Univ Barcelona, Fac Psychol, Dept Clin & Hlth Psychol, Bellaterra, Spain.;CIBER Epidemiol & Publ Hlth CIBERESP, Madrid, Spain.
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- Luciano, Juan, V (author)
- Autonomous 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.
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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)
- Sage Publications, 2024
- 2024
- English.
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In: Digital Health. - : Sage Publications. - 2055-2076. ; 10
- Related links:
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https://uu.diva-port... (primary) (Raw object)
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Abstract
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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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Psykiatri (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Psychiatry (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
- SAMHÄLLSVETENSKAP -- Psykologi -- Tillämpad psykologi (hsv//swe)
- SOCIAL SCIENCES -- Psychology -- Applied Psychology (hsv//eng)
Keyword
- Fibromyalgia
- chronic pain
- Acceptance and Commitment Therapy
- cost-utility
- biomarkers
- mHealth technology
- mobile applications
- smartphone
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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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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show more...
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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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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Psychiatry
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Neurology
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- SOCIAL SCIENCES
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SOCIAL SCIENCES
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and Psychology
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and Applied Psycholo ...
- Articles in the publication
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Digital Health
- By the university
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Uppsala University