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  • Sanabria-Mazo, Juan P.Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.;Univ Int Catalunya, Dept Med, Barcelona, Spain.;Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain. (författare)

Efficacy, cost-utility and physiological effects of Acceptance and Commitment Therapy (ACT) and Behavioural Activation Treatment for Depression (BATD) in patients with chronic low back pain and depression : study protocol of a randomised, controlled trial including mobile-technology-based ecological momentary assessment (IMPACT study)

  • Artikel/kapitelEngelska2020

Förlag, utgivningsår, omfång ...

  • 2020-07-23
  • BMJ,2020
  • electronicrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-459895
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-459895URI
  • https://doi.org/10.1136/bmjopen-2020-038107DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

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Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Introduction The IMPACT study focuses on chronic low back pain (CLBP) and depression symptoms, a prevalent and complex problem that represents a challenge for health professionals. Acceptance and Commitment Therapy (ACT) and Brief Behavioural Activation Treatment for Depression (BATD) are effective treatments for patients with persistent pain and depression, respectively. The objectives of this 12 month, multicentre, randomised, controlled trial (RCT) are (i) to examine the efficacy and cost-utility of adding a group-based form of ACT or BATD to treatment-as-usual (TAU) for patients with CLBP and moderate to severe levels of depressive symptoms; (ii) identify pre-post differences in levels of some physiological variables and (iii) analyse the role of polymorphisms in theFKBP5gene, psychological process measures and physiological variables as mediators or moderators of long-term clinical changes. Methods and analysis Participants will be 225 patients with CLBP and moderate to severe depression symptoms recruited at Parc Sanitari Sant Joan de Deu (St. Boi de Llobregat, Spain) and Hospital del Mar (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs TAU+ACT versus TAU+BATD. A comprehensive assessment to collect clinical variables and costs will be conducted pretreatment, post-treatment and at 12 months follow-up, being pain interference the primary outcome measure. The following physiological variables will be considered at pretreatment and post-treatment assessments in 50% of the sample: immune-inflammatory markers, hair cortisol and cortisone, serum cortisol, corticosteroid-binding globulin and vitamin D. Polymorphisms in theFKBP5gene (rs3800373, rs9296158, rs1360780, rs9470080 and rs4713916) will be analysed at baseline assessment. Moreover, we will include mobile-technology-based ecological momentary assessment, through the Pain Monitor app, to track ongoing clinical status during ACT and BATD treatments. Linear mixed-effects models using restricted maximum likelihood, and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed. Ethics and dissemination This study has been approved by the Ethics Committee of the Fundacio Sant Joan de Deu and Hospital del Mar. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Forero, Carlos G.Univ Int Catalunya, Dept Med, Barcelona, Spain. (författare)
  • Cristobal-Narvaez, PaulaParc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.;Inst Hlth Carlos III, Network Ctr Biomed Res Mental Hlth CIBERSAM, Madrid, Spain. (författare)
  • Suso-Ribera, CarlosUniv Jaume 1, Dept Basic & Clin Psychol & Psychobiol, Castellon de La Plana, Spain.;Inst Hlth Carlos III, Biomed Res Ctr Physiopathol Obes & Nutr CIBERobn, Madrid, Spain. (författare)
  • Garcia-Palacios, AzucenaUniv Jaume 1, Dept Basic & Clin Psychol & Psychobiol, Castellon de La Plana, Spain.;Inst Hlth Carlos III, Biomed Res Ctr Physiopathol Obes & Nutr CIBERobn, Madrid, Spain. (författare)
  • Colomer-Carbonell, AriadnaAutonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.;Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain. (författare)
  • Perez-Aranda, AdrianAutonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.;Consorci Parc Salut MAR Barcelona, Barcelona, Catalunya, Spain. (författare)
  • Andres-Rodriguez, LauraAutonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain. (författare)
  • McCracken, Lance M.,1962-Uppsala universitet,Institutionen för psykologi(Swepub:uu)lanmc300 (författare)
  • D'Amico, FrancescoLondon Sch Econ & Polit Sci, Personal Social Serv Res Unit, London, England. (författare)
  • Estivill-Rodriguez, PereParc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain. (författare)
  • Carreras-Marcos, BernatParc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain. (författare)
  • Montes-Perez, AntonioConsorci Parc Salut MAR Barcelona, Barcelona, Catalunya, Spain. (författare)
  • Comps-Vicente, OlgaConsorci Parc Salut MAR Barcelona, Barcelona, Catalunya, Spain. (författare)
  • Esteve, MontserratInst Hlth Carlos III, Biomed Res Ctr Physiopathol Obes & Nutr CIBERobn, Madrid, Spain.;Univ Barcelona, Dept Biochem & Mol Biomed, Barcelona, Spain.;Univ Barcelona, Inst Biomed IBUB, Barcelona, Spain. (författare)
  • Grasa, MarInst Hlth Carlos III, Biomed Res Ctr Physiopathol Obes & Nutr CIBERobn, Madrid, Spain.;Univ Barcelona, Dept Biochem & Mol Biomed, Barcelona, Spain.;Univ Barcelona, Inst Biomed IBUB, Barcelona, Spain. (författare)
  • Rosa, AraceliInst Hlth Carlos III, Network Ctr Biomed Res Mental Hlth CIBERSAM, Madrid, Spain.;Univ Barcelona, Dept Evolutionary Biol Ecol & Environm Sci, Barcelona, Spain. (författare)
  • Cuesta-Vargas, Antonio, IQueensland Univ Technol, Fac Hlth, Brisbane, Qld, Australia.;Univ Malaga, Dept Physiotherapy, Malaga, Spain.;Biomed Res Inst Malaga IBIMA, Malaga, Spain. (författare)
  • Maes, MichaelChulalongkorn Univ, Dept Psychiat, Bangkok, Thailand. (författare)
  • Borras, XavierAutonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain. (författare)
  • Edo, SilviaAutonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain. (författare)
  • Sanz, AntoniAutonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain. (författare)
  • Feliu-Soler, AlbertAutonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.;Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain. (författare)
  • Castano-Asins, Juan R.Consorci Parc Salut MAR Barcelona, Barcelona, Catalunya, Spain. (författare)
  • Luciano, Juan, VParc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain. (författare)
  • Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.;Univ Int Catalunya, Dept Med, Barcelona, Spain.;Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.Univ Int Catalunya, Dept Med, Barcelona, Spain. (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:BMJ Open: BMJ10:72044-6055

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  • BMJ Open (Sök värdpublikationen i LIBRIS)

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