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Start Over Language english Publisher bmj publishing group
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3. 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)

Author

Carlos Suso-Ribera, Francesco D'Amico, Antonio Cuesta-Vargas, Juan P. Sanabria-Mazo, Antoni Sanz, Juan R. Castaño-Asins, Pere Estivill-Rodríguez, Paula Cristóbal-Narváez, Albert Feliu-Soler, Adrián Pérez-Aranda, Grasa Mm, Antonio Montes-Pérez, Azucena García-Palacios, Lance M. McCracken, Carlos G. Forero, Michael Maes, Araceli Rosa, Xavier Borrás, Juan V. Luciano, Ariadna Colomer-Carbonell, Bernat Carreras-Marcos, Laura Andrés-Rodríguez, Silvia Edo, Olga Comps-Vicente, Montserrat Esteve, This study has been funded by the Institute of Health Carlos III (ISCIII, and PI19/00112 & PI16/00165 have been cofinanced with European Union ERDF funds). JVL has a 'Miguel Servet Type II' contract from the ISCIII (CPII19/00003). ISCIII did not have any role in the analysis and interpretation of data, in the writing of the manuscript and in the decision to submit the paper for publication.

Subjects
Technology, General Practice, lcsh:Medicine, Impact study, Chronic pain, R Medicine (General), Acceptance and commitment therapy, law.invention, Clinical trials, Randomized controlled trial, Terapia de aceptación y compromiso, law, Depresión, Tratamiento breve de activación conductual para la depresión, Dolor persistente, Persistent pain, Medicine, Multicenter Studies as Topic, Depressió psíquica, Depression (differential diagnoses), Applied Psychology, Randomized Controlled Trials as Topic, Ecology, Depression, Teràpia racional emotiva conductual, General Medicine, Dolor crònic, Chronic low back pain, Mental depression, Rational emotive behavior therapy, BF Psychology, Ecological Momentary Assessment, Clinical trials, Depression & mood disorders, pain management, Brief behavioral activation treatment for depression, 159.9, Health Economics, Dolor lumbar crónico, Humans, Tractament breu d’activació conductual per a la depressió, Acceptance and Commitment Therapy, Protocol (science), Dolor lumbar crònic, business.industry, lcsh:R, Teràpia d’acceptació i compromís, Dolor persistent, Tillämpad psykologi, Pain management, Clinical trial, Allmänmedicin, pain management, Spain, Depression & mood disorders, Economic evaluation, Depressió, business, Low Back Pain
Abstract

IntroductionThe 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 analysisParticipants 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.Ethics and disseminationThis 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 numberNCT04140838

Published
2020