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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)

Sanabria-Mazo, Juan P. (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.
Forero, Carlos G. (författare)
Univ Int Catalunya, Dept Med, Barcelona, Spain.
Cristobal-Narvaez, Paula (författare)
Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.;Inst Hlth Carlos III, Network Ctr Biomed Res Mental Hlth CIBERSAM, Madrid, Spain.
visa fler...
Suso-Ribera, Carlos (författare)
Univ 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.
Garcia-Palacios, Azucena (författare)
Univ 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.
Colomer-Carbonell, Ariadna (författare)
Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.;Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.
Perez-Aranda, Adrian (författare)
Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.;Consorci Parc Salut MAR Barcelona, Barcelona, Catalunya, Spain.
Andres-Rodriguez, Laura (författare)
Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.
McCracken, Lance M., 1962- (författare)
Uppsala universitet,Institutionen för psykologi
D'Amico, Francesco (författare)
London Sch Econ & Polit Sci, Personal Social Serv Res Unit, London, England.
Estivill-Rodriguez, Pere (författare)
Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.
Carreras-Marcos, Bernat (författare)
Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.
Montes-Perez, Antonio (författare)
Consorci Parc Salut MAR Barcelona, Barcelona, Catalunya, Spain.
Comps-Vicente, Olga (författare)
Consorci Parc Salut MAR Barcelona, Barcelona, Catalunya, Spain.
Esteve, Montserrat (författare)
Inst 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.
Grasa, Mar (författare)
Inst 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.
Rosa, Araceli (författare)
Inst Hlth Carlos III, Network Ctr Biomed Res Mental Hlth CIBERSAM, Madrid, Spain.;Univ Barcelona, Dept Evolutionary Biol Ecol & Environm Sci, Barcelona, Spain.
Cuesta-Vargas, Antonio, I (författare)
Queensland Univ Technol, Fac Hlth, Brisbane, Qld, Australia.;Univ Malaga, Dept Physiotherapy, Malaga, Spain.;Biomed Res Inst Malaga IBIMA, Malaga, Spain.
Maes, Michael (författare)
Chulalongkorn Univ, Dept Psychiat, Bangkok, Thailand.
Borras, Xavier (författare)
Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.
Edo, Silvia (författare)
Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.
Sanz, Antoni (författare)
Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.
Feliu-Soler, Albert (författare)
Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.;Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.
Castano-Asins, Juan R. (författare)
Consorci Parc Salut MAR Barcelona, Barcelona, Catalunya, Spain.
Luciano, Juan, V (författare)
Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.
visa färre...
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)
2020-07-23
2020
Engelska.
Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 10:7
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • 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

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Allmänmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- General Practice (hsv//eng)
SAMHÄLLSVETENSKAP  -- Psykologi -- Tillämpad psykologi (hsv//swe)
SOCIAL SCIENCES  -- Psychology -- Applied Psychology (hsv//eng)

Nyckelord

pain management
Clinical trials
Depression & mood disorders

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