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.. (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació)
García Forero, Carlos (Universitat Internacional de Catalunya. Departament de Medicina)
Cristóbal Narváez, Paula (Parc Sanitari Sant Joan de Deu (Sant Boi de Llobregat))
Suso-Ribera, Carlos (Universitat Jaume I. Departament de Psicologia Bàsica, Clínica i Psicobiologia)
García-Palacios, Azucena (Universitat Jaume I. Departament de Psicologia Bàsica, Clínica i Psicobiologia)
Colomer-Carbonell, Ariadna (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació)
Pérez-Aranda, Adrián (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació)
Andrés Rodríguez, Laura (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació)
McCracken, Lance M (Uppsala University. Psychology Department)
D'Amico, Francesco (London School of Economics and Political Science. Personal Social Services Research Unit)
Estivill, Pere (Parc Sanitari Sant Joan de Deu)
Carreras-Marcos, Bernat (Parc Sanitari Sant Joan de Deu)
Montes-Pérez, Antonio (Parc de Salut MAR de Barcelona)
Comps, Olga (Parc de Salut MAR de Barcelona)
Esteve, Montserrat (Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición)
Grasa, Mar (Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición)
Rosa, Araceli (Centro de Investigación Biomédica en Red de Salud Mental)
Cuesta-Vargas, Antonio I (Queensland University of Technology (Brisbane, Queensland). Faculty of Health)
Maes, Michael (Chulalongkorn University. Department of Psychiatry)
Borràs, Xavier (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació)
Edo Izquierdo, Sílvia (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació)
Sanz Ruiz, Antoni (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació)
Feliu-Soler, Albert (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació)
Castaño Asins, Juan Ramon (Parc de Salut MAR de Barcelona)
Luciano, Juan V (Parc Sanitari Sant Joan de Deu)

Date:	2020
Abstract:	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 the FKBP5 gene, psychological process measures and physiological variables as mediators or moderators of long-term clinical changes. Participants will be 225 patients with CLBP and moderate to severe depression symptoms recruited at Parc Sanitari Sant Joan de Déu (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 the FKBP5 gene (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. This study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu and Hospital del Mar. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities.
Grants:	Instituto de Salud Carlos III CPII19/00003 Instituto de Salud Carlos III PI16/00165 Instituto de Salud Carlos III PI19/00112
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Pain management ; Clinical trials ; Depression & mood disorders
Published in:	BMJ open, Vol. 10 (july 2020) , ISSN 2044-6055

DOI: 10.1136/bmjopen-2020-038107
PMID: 32709656

13 p, 661.0 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > GIES (Grup de Recerca en Estrès i Salut)
Articles > Research articles
Articles > Published articles