1 Sanabria-Mazo JP, et al. BMJ Open 2020;10:e038107. doi:10.1136/bmjopen-2020-038107 Open access Effcacy, 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) Juan P Sanabria-Mazo , 1,2,3 Carlos G Forero, 2 Paula Cristobal-Narváez, 3,4 Carlos Suso-Ribera, 5,6 Azucena García-Palacios, 5,6 Ariadna Colomer-Carbonell, 1,3 Adrián Pérez-Aranda, 1,7 Laura Andrés-Rodríguez, 1 Lance M McCracken, 8 Francesco D'Amico, 9 Pere Estivill-Rodríguez, 3 Bernat Carreras-Marcos, 3 Antonio Montes-Pérez, 7 Olga Comps-Vicente, 7 Montserrat Esteve, 6,10,11 Mar Grasa, 6,10,11 Araceli Rosa, 4,12 Antonio I Cuesta-Vargas , 13,14 Michael Maes, 15 Xavier Borràs , 1 Silvia Edo, 1 Antoni Sanz, 1 Albert Feliu-Soler, 1,3 Juan R Castaño-Asins, 7 Juan V Luciano 3 To cite: Sanabria-Mazo JP, Forero CG, Cristobal-Narváez P, et al. Effcacy, 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;10:e038107. doi:10.1136/ bmjopen-2020-038107 ► Prepublication history and additional material for this paper are available online. To view these fles, please visit the journal online (http://dx.doi. org/10.1136/bmjopen-2020- 038107). JPS-M and CS-R are joint frst authors. AF-S, JRC-A and JVL are joint senior authors. Received 27 February 2020 Revised 30 May 2020 Accepted 11 June 2020 For numbered affliations see end of article. Correspondence to Juan V Luciano; jvluciano@pssjd.org Protocol © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ABSTRACT 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 effcacy 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-infammatory 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. Ethics and dissemination 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. Trial registration number NCT04140838 on February 23, 2022 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2020-038107 on 23 July 2020. Downloaded from