RT Journal Article
T1 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)
A1 Sanabria-Mazo, Juan P
A1 Forero, Carlos G
A1 Cristobal-Narváez, Paula
A1 Suso-Ribera, Carlos
A1 García-Palacios, Azucena
A1 Colomer-Carbonell, Ariadna
A1 Pérez-Aranda, Adrián
A1 Andrés-Rodríguez, Laura
A1 McCracken, Lance M
A1 D'Amico, Francesco
A1 Estivill-Rodríguez, Pere
A1 Carreras-Marcos, Bernat
A1 Montes-Pérez, Antonio
A1 Comps-Vicente, Olga
A1 Esteve, Montserrat
A1 Grasa, Mar
A1 Rosa, Araceli
A1 Cuesta-Vargas, Antonio
A1 Maes, Michael
A1 Borràs, Xavier
A1 Edo, Silvia
A1 Sanz, Antoni
A1 Feliu-Soler, Albert
A1 Castaño-Asins, Juan R
A1 Luciano, Juan V
K1 Depresión mental - Tratamiento
K1 Vértebras lumbares - Enfermedades
AB 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 the FKBP5 gene, 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 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.
PB BMJ Journals
YR 2020
FD 2020-07-23
LK https://hdl.handle.net/10630/36029
UL https://hdl.handle.net/10630/36029
LA eng
NO Sanabria-Mazo JP, Forero CG, Cristobal-Narváez P, Suso-Ribera C, García-Palacios A, Colomer-Carbonell A, Pérez-Aranda A, Andrés-Rodríguez L, McCracken LM, D'Amico F, Estivill-Rodríguez P, Carreras-Marcos B, Montes-Pérez A, Comps-Vicente O, Esteve M, Grasa M, Rosa A, Cuesta-Vargas AI, Maes M, Borràs X, Edo S, Sanz A, Feliu-Soler A, Castaño-Asins JR, Luciano JV. 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). BMJ Open. 2020 Jul 23;10(7):e038107. doi: 10.1136/bmjopen-2020-038107. PMID: 32709656; PMCID: PMC7380881.
DS RIUMA. Repositorio Institucional de la Universidad de Málaga
RD 21 ene 2026