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)

Juan P Sanabria-Mazo, Carlos G Forero, Paula Cristobal-Narváez, Carlos Suso-Ribera, Azucena García-Palacios, Ariadna Colomer-Carbonell, Adrián Pérez-Aranda, Laura Andrés-Rodríguez, Lance M McCracken, Francesco D'Amico, Pere Estivill-Rodríguez, Bernat Carreras-Marcos, Antonio Montes-Pérez, Olga Comps-Vicente, Montserrat Esteve, Mar Grasa, Araceli Rosa, Antonio I Cuesta-Vargas, Michael Maes, Xavier Borràs, Silvia Edo, Antoni Sanz, Albert Feliu-Soler, Juan R Castaño-Asins, Juan V Luciano, Juan P Sanabria-Mazo, Carlos G Forero, Paula Cristobal-Narváez, Carlos Suso-Ribera, Azucena García-Palacios, Ariadna Colomer-Carbonell, Adrián Pérez-Aranda, Laura Andrés-Rodríguez, Lance M McCracken, Francesco D'Amico, Pere Estivill-Rodríguez, Bernat Carreras-Marcos, Antonio Montes-Pérez, Olga Comps-Vicente, Montserrat Esteve, Mar Grasa, Araceli Rosa, Antonio I Cuesta-Vargas, Michael Maes, Xavier Borràs, Silvia Edo, Antoni Sanz, Albert Feliu-Soler, Juan R Castaño-Asins, Juan V Luciano

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 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. 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.

Keywords: Clinical trials; Depression & mood disorders; pain management.

Conflict of interest statement

Competing interests: None declared.

© 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.

Figures

Figure 1
Figure 1
Flowchart of the IMPACT study based on the Consolidated Standards of Reporting Trials guidelines. ACT, Acceptance and Commitment Therapy; BATD, Brief Behavioural Activation Treatment for Depression; CLBP, chronic low back pain; EMA, ecological momentary assessment; ITT, intention-to-treat; TAU, treatment as usual.

References

    1. Mansfield KE, Sim J, Jordan JL, et al. . A systematic review and meta-analysis of the prevalence of chronic widespread pain in the general population. Pain 2016;157:55–64. 10.1097/j.pain.0000000000000314
    1. Sá KN, Moreira L, Baptista AF, et al. . Prevalence of chronic pain in developing countries: systematic review and meta-analysis. Pain Rep 2019;4:e779. 10.1097/PR9.0000000000000779
    1. Hoy D, March L, Brooks P, et al. . The global burden of low back pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis 2014;73:968–74. 10.1136/annrheumdis-2013-204428
    1. Vlaeyen JWS, Maher CG, Wiech K, et al. . Low back pain. Nat Rev Dis Primers 2018;4:52. 10.1038/s41572-018-0052-1
    1. Otte C, Gold SM, Penninx BW, et al. . Major depressive disorder. Nat Rev Dis Primers 2016;2:16065. 10.1038/nrdp.2016.65
    1. Rayner L, Hotopf M, Petkova H, et al. . Depression in patients with chronic pain attending a specialised pain treatment centre: prevalence and impact on health care costs. Pain 2016;157:1472–9. 10.1097/j.pain.0000000000000542
    1. Kroenke K, Wu J, Bair MJ, et al. . Reciprocal relationship between pain and depression: a 12-month longitudinal analysis in primary care. J Pain 2011;12:964–73. 10.1016/j.jpain.2011.03.003
    1. Dell'Osso L, Bazzichi L, Baroni S, et al. . The inflammatory hypothesis of mood spectrum broadened to fibromyalgia and chronic fatigue syndrome. Clin Exp Rheumatol 2015;33:S109–16.
    1. Lim YZ, Wang Y, Cicuttini FM, et al. . Association between inflammatory biomarkers and nonspecific low back pain. Clin J Pain 2020;36:379–89. 10.1097/AJP.0000000000000810
    1. Maes M, Carvalho AF. The compensatory Immune-Regulatory reflex system (CIRS) in depression and bipolar disorder. Mol Neurobiol 2018;55:8885–903. 10.1007/s12035-018-1016-x
    1. von Känel R, Müller-Hartmannsgruber V, Kokinogenis G, et al. . Vitamin D and central hypersensitivity in patients with chronic pain. Pain Med 2014;15:1609–18. 10.1111/pme.12454
    1. Martin KR, Reid DM. Is there role for vitamin D in the treatment of chronic pain? Ther Adv Musculoskelet Dis 2017;9:131–5. 10.1177/1759720X17708124
    1. Pu D, Luo J, Wang Y, et al. . Prevalence of depression and anxiety in rheumatoid arthritis patients and their associations with serum vitamin D level. Clin Rheumatol 2018;37:179–84. 10.1007/s10067-017-3874-4
    1. Shipton EE, Shipton EA. Vitamin D deficiency and pain: clinical evidence of low levels of vitamin D and supplementation in chronic pain states. Pain Ther 2015;4:67–87. 10.1007/s40122-015-0036-8
    1. Cashman KD, Dowling KG, Škrabáková Z, et al. . Vitamin D deficiency in Europe: pandemic? Am J Clin Nutr 2016;103:1033–44. 10.3945/ajcn.115.120873
    1. Arango-Dávila CA, Rincón-Hoyos HG. Depressive disorder, anxiety disorder and chronic pain: multiple manifestations of a common clinical and pathophysiological core. Rev Colomb Psiquiatr 2018;47:46–55. 10.1016/j.rcpeng.2017.12.003
    1. Chrousos GP. Stress and disorders of the stress system. Nat Rev Endocrinol 2009;5:374–81. 10.1038/nrendo.2009.106
    1. Woda A, Picard P, Dutheil F. Dysfunctional stress responses in chronic pain. Psychoneuroendocrinology 2016;71:127–35. 10.1016/j.psyneuen.2016.05.017
    1. Wei J, Sun G, Zhao L, et al. . Analysis of hair cortisol level in first-episodic and recurrent female patients with depression compared to healthy controls. J Affect Disord 2015;175:299–302. 10.1016/j.jad.2015.01.023
    1. Biondi M, Picardi A. Psychological stress and neuroendocrine function in humans: the last two decades of research. Psychother Psychosom 1999;68:114–50. 10.1159/000012323
    1. Sudhaus S, Fricke B, Stachon A, et al. . Salivary cortisol and psychological mechanisms in patients with acute versus chronic low back pain. Psychoneuroendocrinology 2009;34:513–22. 10.1016/j.psyneuen.2008.10.011
    1. Yin H, Galfalvy H, Pantazatos SP, et al. . Glucocorticoid receptor-related genes: genotype and brain gene expression relationships to suicide and major depressive disorder. Depress Anxiety 2016;33:531–40. 10.1002/da.22499
    1. Fischer S, King S, Papadopoulos A, et al. . Hair cortisol and childhood trauma predict psychological therapy response in depression and anxiety disorders. Acta Psychiatr Scand 2018;138:526–35. 10.1111/acps.12970
    1. Zannas AS, Wiechmann T, Gassen NC, et al. . Gene-Stress-Epigenetic regulation of FKBP5: clinical and translational implications. Neuropsychopharmacology 2016;41:261–74. 10.1038/npp.2015.235
    1. Roberts S, Keers R, Breen G, et al. . Dna methylation of FKBP5 and response to exposure-based psychological therapy. Am J Med Genet B Neuropsychiatr Genet 2019;180:150–8. 10.1002/ajmg.b.32650
    1. Géranton SM. Does epigenetic 'memory' of early-life stress predispose to chronic pain in later life? A potential role for the stress regulator FKBP5. Philos Trans R Soc Lond B Biol Sci 2019;374:20190283. 10.1098/rstb.2019.0283
    1. Moraes LJ, Miranda MB, Loures LF, et al. . A systematic review of psychoneuroimmunology-based interventions. Psychol Health Med 2018;23:635–52. 10.1080/13548506.2017.1417607
    1. Hughes LS, Clark J, Colclough JA, et al. . Acceptance and commitment therapy (act) for chronic pain: a systematic review and meta-analyses. Clin J Pain 2017;33:552–68. 10.1097/AJP.0000000000000425
    1. Cuijpers P, van Straten A, Warmerdam L. Behavioral activation treatments of depression: a meta-analysis. Clin Psychol Rev 2007;27:318–26. 10.1016/j.cpr.2006.11.001
    1. Feliu-Soler A, Cebolla A, McCracken LM, et al. . Economic impact of third-wave cognitive behavioral therapies: a systematic review and quality assessment of economic evaluations in randomized controlled trials. Behav Ther 2018;49:124–47. 10.1016/j.beth.2017.07.001
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Schulz KF, Altman DG, Moher D, et al. . Consort 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332. 10.1136/bmj.c332
    1. Husereau D, Drummond M, Petrou S, et al. . Consolidated health economic evaluation reporting standards (cheers) statement. BMC Med 2013;11:80. 10.1186/1741-7015-11-80
    1. Casey M-B, Smart K, Segurado R, et al. . Exercise combined with acceptance and commitment therapy (exact) compared to a supervised exercise programme for adults with chronic pain: study protocol for a randomised controlled trial. Trials 2018;19:194. 10.1186/s13063-018-2543-5
    1. Rabey M, Smith A, Beales D, et al. . Differing psychologically derived clusters in people with chronic low back pain are associated with different multidimensional profiles. Clin J Pain 2016;32:1015–27. 10.1097/AJP.0000000000000363
    1. Pérez-Aranda A, Feliu-Soler A, Montero-Marín J, et al. . A randomized controlled efficacy trial of mindfulness-based stress reduction compared with an active control group and usual care for fibromyalgia: the EUDAIMON study. Pain 2019;160:2508–23. 10.1097/j.pain.0000000000001655
    1. Hayes SC, Villatte M, Levin M, et al. . Open, aware, and active: contextual approaches as an emerging trend in the behavioral and cognitive therapies. Annu Rev Clin Psychol 2011;7:141–68. 10.1146/annurev-clinpsy-032210-104449
    1. McCracken LM, Morley S. The psychological flexibility model: a basis for integration and progress in psychological approaches to chronic pain management. J Pain 2014;15:221–34. 10.1016/j.jpain.2013.10.014
    1. Veehof MM, Trompetter HR, Bohlmeijer ET, et al. . Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther 2016;45:5–31. 10.1080/16506073.2015.1098724
    1. Ost L-G. The efficacy of acceptance and commitment therapy: an updated systematic review and meta-analysis. Behav Res Ther 2014;61:105–21. 10.1016/j.brat.2014.07.018
    1. Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of the PRIME-MD: the PHQ primary care study. JAMA 1999;282:1737–44.
    1. McMillan D, Gilbody S, Richards D. Defining successful treatment outcome in depression using the PHQ-9: a comparison of methods. J Affect Disord 2010;127:122–9. 10.1016/j.jad.2010.04.030
    1. Pinto-Meza A, Serrano-Blanco A, Peñarrubia MT, et al. . Assessing depression in primary care with the PHQ-9: can it be carried out over the telephone? J Gen Intern Med 2005;20:738–42. 10.1111/j.1525-1497.2005.0144.x
    1. Wittchen HU. Reliability and validity studies of the WHO--Composite International Diagnostic Interview (CIDI): a critical review. J Psychiatr Res 1994;28:57–84. 10.1016/0022-3956(94)90036-1
    1. Bernstein DP, Stein JA, Newcomb MD, et al. . Development and validation of a brief screening version of the childhood trauma questionnaire. Child Abuse Negl 2003;27:169–90. 10.1016/S0145-2134(02)00541-0
    1. Hernández A, Gallardo-Pujol D, Pereda N, et al. . Initial validation of the Spanish childhood trauma questionnaire-short form: factor structure, reliability and association with parenting. J Interpers Violence 2013;28:1498–518. 10.1177/0886260512468240
    1. Cleeland CS, Ryan KM. Pain assessment: global use of the brief pain inventory. Ann Acad Med Singapore 1994;23:129–38.
    1. Kaiser U, Kopkow C, Deckert S, et al. . Developing a core outcome domain set to assessing effectiveness of interdisciplinary multimodal pain therapy: the VAPAIN consensus statement on core outcome domains. Pain 2018;159:673–83. 10.1097/j.pain.0000000000001129
    1. Chiarotto A, Boers M, Deyo RA, et al. . Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain 2018;159:481–95. 10.1097/j.pain.0000000000001117
    1. Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the depression anxiety stress scales (DASS) with the Beck depression and anxiety inventories. Behav Res Ther 1995;33:335–43. 10.1016/0005-7967(94)00075-U
    1. Taylor R, Lovibond PF, Nicholas MK, et al. . The utility of somatic items in the assessment of depression in patients with chronic pain: a comparison of the Zung self-rating depression scale and the depression anxiety stress scales in chronic pain and clinical and community samples. Clin J Pain 2005;21:91–100. 10.1097/00002508-200501000-00011
    1. Bados A, Solanas A, Andrés R. Psychometric properties of the Spanish version of depression, anxiety and stress scales (DASS). Psicothema 2005;17:679–83.
    1. Sullivan MJL, Bishop SR, Pivik J. The pain Catastrophizing scale: development and validation. Psychol Assess 1995;7:524–32. 10.1037/1040-3590.7.4.524
    1. García Campayo J, Rodero B, Alda M, et al. . [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin 2008;131:487–92. 10.1157/13127277
    1. Fish RA, Hogan MJ, Morrison TG, et al. . Willing and able: a closer look at pain willingness and activity engagement on the chronic pain acceptance questionnaire (CPAQ-8). J Pain 2013;14:233–45. 10.1016/j.jpain.2012.11.004
    1. Sánchez-Rodríguez E, de la Vega R, Racine M, et al. . Support for the Spanish version of the CPAQ-8 as a measure of chronic pain acceptance. J Eval Clin Pract 2019;25:881–8. 10.1111/jep.13092
    1. Manos RC, Kanter JW, Luo W. The behavioral activation for depression scale-short form: development and validation. Behav Ther 2011;42:726–39. 10.1016/j.beth.2011.04.004
    1. Barraca J, Pérez-Alvarez M, Lozano Bleda JH. Avoidance and activation as keys to depression: adaptation of the behavioral activation for depression scale in a Spanish sample. Span J Psychol 2011;14:998–1009. 10.5209/rev_SJOP.2011.v14.n2.45
    1. Herdman M, Gudex C, Lloyd A, et al. . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20:1727–36. 10.1007/s11136-011-9903-x
    1. Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry 2000;31:73–86. 10.1016/S0005-7916(00)00012-4
    1. Vázquez-Barquero JL, Gaite L, Cuesta MJ, et al. . Spanish version of the CSRI: a mental health cost evaluation interview. Arch Neurobiol 1997;60:171–84.
    1. Scott W, McCracken LM. Patients' impression of change following treatment for chronic pain: global, specific, a single dimension, or many? J Pain 2015;16:518–26. 10.1016/j.jpain.2015.02.007
    1. O'Neill L, Latchford G, McCracken LM, et al. . The development of the acceptance and commitment therapy fidelity measure (ACT-FM): a Delphi study and field test. J Contextual Behav Sci 2019;14:111–8. 10.1016/j.jcbs.2019.08.008
    1. Dimidjian S, Hubley A, Martell C, et al. . The quality of behavioral activation scale (QBAS). Boulder: University of Colorado, 2012.
    1. Garcia-Palacios A, Herrero R, Belmonte MA, et al. . Ecological momentary assessment for chronic pain in fibromyalgia using a smartphone: a randomized crossover study. Eur J Pain 2014;18:862–72. 10.1002/j.1532-2149.2013.00425.x
    1. May M, Junghaenel DU, Ono M, et al. . Ecological momentary assessment methodology in chronic pain research: a systematic review. J Pain 2018;19:699–716. 10.1016/j.jpain.2018.01.006
    1. Suso-Ribera C, Mesas Ángela, Medel J, et al. . Improving pain treatment with a smartphone APP: study protocol for a randomized controlled trial. Trials 2018;19:145. 10.1186/s13063-018-2539-1
    1. Suso-Ribera C, Castilla D, Zaragozá I, et al. . Validity, reliability, feasibility, and usefulness of pain monitor, a multidimensional smartphone APP for daily monitoring of adults with heterogeneous chronic pain. Clin J Pain 2018;34:1–8. 10.1097/AJP.0000000000000618
    1. Crawford DC, Nickerson DA. Definition and clinical importance of haplotypes. Annu Rev Med 2005;56:303–20. 10.1146/annurev.med.56.082103.104540
    1. Barrett JC, Fry B, Maller J, et al. . Haploview: analysis and visualization of LD and haplotype maps. Bioinformatics 2005;21:263–5. 10.1093/bioinformatics/bth457
    1. Stephens M, Donnelly P. A comparison of Bayesian methods for haplotype reconstruction from population genotype data. Am J Hum Genet 2003;73:1162–9. 10.1086/379378
    1. Duarte R, Lloyd A, Kotas E, et al. . Are acceptance and mindfulness-based interventions 'value for money'? Evidence from a systematic literature review. Br J Clin Psychol 2019;58:187–210. 10.1111/bjc.12208
    1. Lahti J, Ala-Mikkula H, Kajantie E, et al. . Associations between self-reported and objectively recorded early life stress, FKBP5 polymorphisms, and depressive symptoms in midlife. Biol Psychiatry 2016;80:869–77. 10.1016/j.biopsych.2015.10.022
    1. de Castro-Catala M, Peña E, Kwapil TR, et al. . Interaction between FKBP5 gene and childhood trauma on psychosis, depression and anxiety symptoms in a non-clinical sample. Psychoneuroendocrinology 2017;85:200–9. 10.1016/j.psyneuen.2017.08.024
    1. Isaksson J, Comasco E, Åslund C, et al. . Associations between the FKBP5 haplotype, exposure to violence and anxiety in females. Psychoneuroendocrinology 2016;72:196–204. 10.1016/j.psyneuen.2016.07.206

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다