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)

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Fältnamn	Indikatorer	Metadata
000		08401naa a2200673 4500
001		oai:DiVA.org:uu-459895
003		SwePub
008		211206s2020 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
024	7	a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-4598952 URI
024	7	a https://doi.org/10.1136/bmjopen-2020-0381072 DOI
040		a (SwePub)uu
041		a engb eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Sanabria-Mazo, Juan P.u 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.4 aut
245	1 0	a 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 :b study protocol of a randomised, controlled trial including mobile-technology-based ecological momentary assessment (IMPACT study)
264		c 2020-07-23
264	1	b BMJ,c 2020
338		a electronic2 rdacarrier
520		a 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.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Allmänmedicin0 (SwePub)302242 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex General Practice0 (SwePub)302242 hsv//eng
650	7	a SAMHÄLLSVETENSKAPx Psykologix Tillämpad psykologi0 (SwePub)501022 hsv//swe
650	7	a SOCIAL SCIENCESx Psychologyx Applied Psychology0 (SwePub)501022 hsv//eng
653		a pain management
653		a Clinical trials
653		a Depression & mood disorders
700	1	a Forero, Carlos G.u Univ Int Catalunya, Dept Med, Barcelona, Spain.4 aut
700	1	a Cristobal-Narvaez, Paulau 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.4 aut
700	1	a Suso-Ribera, Carlosu 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.4 aut
700	1	a Garcia-Palacios, Azucenau 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.4 aut
700	1	a Colomer-Carbonell, Ariadnau Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.;Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.4 aut
700	1	a Perez-Aranda, Adrianu Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.;Consorci Parc Salut MAR Barcelona, Barcelona, Catalunya, Spain.4 aut
700	1	a Andres-Rodriguez, Laurau Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.4 aut
700	1	a McCracken, Lance M.,d 1962-u Uppsala universitet,Institutionen för psykologi4 aut0 (Swepub:uu)lanmc300
700	1	a D'Amico, Francescou London Sch Econ & Polit Sci, Personal Social Serv Res Unit, London, England.4 aut
700	1	a Estivill-Rodriguez, Pereu Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.4 aut
700	1	a Carreras-Marcos, Bernatu Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.4 aut
700	1	a Montes-Perez, Antoniou Consorci Parc Salut MAR Barcelona, Barcelona, Catalunya, Spain.4 aut
700	1	a Comps-Vicente, Olgau Consorci Parc Salut MAR Barcelona, Barcelona, Catalunya, Spain.4 aut
700	1	a Esteve, Montserratu 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.4 aut
700	1	a Grasa, Maru 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.4 aut
700	1	a Rosa, Araceliu Inst Hlth Carlos III, Network Ctr Biomed Res Mental Hlth CIBERSAM, Madrid, Spain.;Univ Barcelona, Dept Evolutionary Biol Ecol & Environm Sci, Barcelona, Spain.4 aut
700	1	a Cuesta-Vargas, Antonio, Iu Queensland Univ Technol, Fac Hlth, Brisbane, Qld, Australia.;Univ Malaga, Dept Physiotherapy, Malaga, Spain.;Biomed Res Inst Malaga IBIMA, Malaga, Spain.4 aut
700	1	a Maes, Michaelu Chulalongkorn Univ, Dept Psychiat, Bangkok, Thailand.4 aut
700	1	a Borras, Xavieru Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.4 aut
700	1	a Edo, Silviau Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.4 aut
700	1	a Sanz, Antoniu Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.4 aut
700	1	a Feliu-Soler, Albertu Autonomous Univ Barcelona, Dept Basic Dev & Educ Psychol, Barcelona, Spain.;Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.4 aut
700	1	a Castano-Asins, Juan R.u Consorci Parc Salut MAR Barcelona, Barcelona, Catalunya, Spain.4 aut
700	1	a Luciano, Juan, Vu Parc Sanitari St Joan de Deu, St Boi De Llobregat, Catalunya, Spain.4 aut
710	2	a 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.b Univ Int Catalunya, Dept Med, Barcelona, Spain.4 org
773	0	t BMJ Opend : BMJg 10:7q 10:7x 2044-6055
856	4	u https://doi.org/10.1136/bmjopen-2020-038107y Fulltext
856	4	u https://uu.diva-portal.org/smash/get/diva2:1617419/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print
856	4	u https://bmjopen.bmj.com/content/bmjopen/10/7/e038107.full.pdf
856	4 8	u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-459895
856	4 8	u https://doi.org/10.1136/bmjopen-2020-038107

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