Delivering an Optimised Behavioural Intervention (OBI) to people with low back pain with high psychological risk; results and lessons learnt from a feasibility randomised controlled trial of Contextual Cognitive Behavioural Therapy (CCBT) vs. Physiotherapy

Tamar Pincus, Shamaila Anwar, Lance M McCracken, Alison McGregor, Liz Graham, Michelle Collinson, John McBeth, Paul Watson, Stephen Morley, Juliet Henderson, Amanda J Farrin, OBI Trial Management Team, Barbara Sharp, Mrs Kim Brown, Chantel Ostler, Deborah Joy, Greg Clarke, Tamar Pincus, Shamaila Anwar, Lance M McCracken, Alison McGregor, Liz Graham, Michelle Collinson, John McBeth, Paul Watson, Stephen Morley, Juliet Henderson, Amanda J Farrin, OBI Trial Management Team, Barbara Sharp, Mrs Kim Brown, Chantel Ostler, Deborah Joy, Greg Clarke

Abstract

Background: Low Back Pain (LBP) remains a common and costly problem. Psychological obstacles to recovery have been identified, but psychological and behavioural interventions have produced only moderate improvements. Reviews of trials have suggested that the interventions lack clear theoretical basis, are often compromised by low dose, lack of fidelity, and delivery by non-experts. In addition, interventions do not directly target known risk mechanisms. We identified a theory driven intervention (Contexual Cognitive Behavioural Therapy, CCBT) that directly targets an evidence-based risk mechanism (avoidance and ensured dose and delivery were optimised. This feasibility study was designed to test the credibility and acceptability of optimised CCBT against physiotherapy for avoidant LBP patients, and to test recruitment, delivery of the intervention and response rates prior to moving to a full definitive trial.

Methods: A randomised controlled feasibility trial with patients randomised to receive CCBT or physiotherapy. CCBT was delivered by trained supervised psychologists on a one to one basis and comprised up to 8 one-hour sessions. Physiotherapy comprised back to fitness group exercises with at least 60 % of content exercise-based. Patients were eligible to take part if they had back pain for more than 3 months, and scored above a threshold indicating fear avoidance, catastrophic beliefs and distress.

Results: 89 patients were recruited. Uptake rates were above those predicted. Scores for credibility and acceptability of the interventions met the set criteria. Response rates at three and six months fell short of the 75 % target. Problems associated with poor response rates were identified and successfully resolved, rates increased to 77 % at 3 months, and 68 % at 6 months. Independent ratings of treatment sessions indicated that CCBT was delivered to fidelity. Numbers were too small for formal analysis. Although average scores for acceptance were higher in the CCBT group than in the group attending physiotherapy (increase of 7.9 versus 5.1) and change in disability and pain from baseline to 6 months were greater in the CCBT group than in the physiotherapy group, these findings should be interpreted with caution.

Conclusions: CCBT is a credible and acceptable intervention for LBP patients who exhibit psychological obstacles to recovery.

Trial registration: ISRCTN43733490 , registered 15/12/2010.

Figures

Fig. 1
Fig. 1
Flow chart of recruitment (Additional file 1)

References

    1. Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, Amann M, Anderson HR, Andrews KG, Aryee M, Atkinson C, Bacchus LJ, Bahalim AN, Balakrishnan K, Balmes J, Barker-Collo S, Baxter A, Bell ML, Blore JD, Blyth F, Bonner C, Borges G, Bourne R, Boussinesq M, Brauer M, Brooks P, Bruce NG, Brunekreef B, Bryan-Hancock C, Bucello C, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2224–60. doi: 10.1016/S0140-6736(12)61766-8.
    1. Nicholas MK, Linton SJ, Watson PJ, Main CJ. Early identification and management of psychological risk factors (“yellow flags”) in patients with low back pain: a reappraisal. Phys Ther. 2011;91:737–753. doi: 10.2522/ptj.20100224.
    1. Dixon KE, Keefe FJ, Scipio CD, Perri LM, Abernethy AP. Psychological interventions for arthritis pain management in adults: a meta-analysis. Health Psychol. 2007;26:241–250. doi: 10.1037/0278-6133.26.3.241.
    1. Eccleston C, Williams AC de C, Morley S: Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2009;2:CD007407.
    1. Henschke N, Ostelo RW, van Tulder MW, Vlaeyen JW, Morley S, Assendelft 688 WJ, Main CJ: Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev 2010;7:CD002014.
    1. Hoffman BM, Papas RK, Chatkoff DK, Kerns RD. Meta-analysis of psychological interventions for chronic low back pain. Heal Psychol. 2007;26:1–9. doi: 10.1037/0278-6133.26.1.1.
    1. Morley S, Williams A, Eccleston C. Examining the evidence about psychological treatments for chronic pain: time for a paradigm shift? Pain. 2013;154:1929–31. doi: 10.1016/j.pain.2013.05.049.
    1. Pincus T, McCracken LM. Psychological factors and treatment opportunities in low back pain. Best Pract Res Clin Rheumatol. 2013;27:625–35. doi: 10.1016/j.berh.2013.09.010.
    1. Pincus T, Anwar S, McCracken L, McGregor A, Graham L, Collinson M, Farrin AJ. Testing the credibility, feasibility and acceptability of an optimised behavioural intervention (OBI) for avoidant chronic low back pain patients: protocol for a randomised feasibility study. Trials. 2013;14:172. doi: 10.1186/1745-6215-14-172.
    1. Pincus T, Burton AK, Vogel S, Field AP. A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain. Spine. 2002;27(5):E109–20. doi: 10.1097/00007632-200203010-00017.
    1. Hayden JA, Chou R, Hogg-Johnson S, Bombardier C: Systematic reviews of low back pain prognosis had variable methods and results-guidance for future prognosis reviews. J Clin Epidemiol 2009;62(8):781–796.
    1. Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2012;378(9802):1560–71. doi: 10.1016/S0140-6736(11)60937-9.
    1. Woods MP, Asmundson GJG. Evaluating the efficacy of graded in vivo exposure for the treatment of fear in patients with chronic back pain: A randomized controlled clinical trial. Pain. 2008;136:271–280. doi: 10.1016/j.pain.2007.06.037.
    1. Leeuw M, Goossens MEJB, van Breukelen GJP, de Jong JR, Heuts PHTG, Smeets RJEM, Köke AJA, Vlaeyen JWS. Exposure in vivo versus operant graded activity in chronic low back pain patients: Results of a randomized controlled trial. Pain. 2008;138:192–207. doi: 10.1016/j.pain.2007.12.009.
    1. Crombez G, Eccleston C, Van Damme S, Vlaeyen JWS, Karoly P. Fear-avoidance model of chronic pain: the next generation. Clin J Pain. 2012;28:475–483. doi: 10.1097/AJP.0b013e3182385392.
    1. Simmonds MJ, Goubert L, Moseley GL, Verbunt J. Moving with pain. In: Flor H, Kalso E, Dostrovsky JO, editors. Proceedings of the 11th World Congress on Pain: IASP, Seattle. 2006. pp. 799–811.
    1. Hayes SC, Villatte M, Levin M, Hildebrandt M. Open, aware, and active: contextual approaches as an emerging trend in the behavioral and cognitive therapies. Annu Rev Clin Psychol. 2011;7:141–168. doi: 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;15:221–234. doi: 10.1016/j.jpain.2013.10.014.
    1. Hayes S, Strosahl EAK. Acceptance and Committment Therapy: An experiential approach to behavior change. New York: Guildford Press; 1999.
    1. McCracken LM. Contextual cognitive behavioral therapy for chronic pain. Seattle: IASP; 2005.
    1. McCracken LM, Vowles KE. Acceptance and commitment therapy and mindfulness for chronic pain: model, process, and progress. Am Psychol. 2014;69:178–87. doi: 10.1037/a0035623.
    1. National Collaborating Centre for Primary Care. Lower back pain: Early management of persistent non-specific low back pain Guideline 88. London: National Institute of Health and Clinical Excellence; 2009.
    1. Kori SH, Miller RP, Todd DD. Kinesiophobia: a new view of chronic pain behaviour. Pain Management. 1990;3:35–43.
    1. Hill JC, Dunn KM. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum. 2008;59(5):632–41. doi: 10.1002/art.23563.
    1. Keller S, Bann MA. Validity of the Brief Pain Inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain. 2004;20(5):310–318. doi: 10.1097/00002508-200409000-00005.
    1. Cleeland CS. Effect of Cancer on Quality of Life. In: Osaba D, editor. Effect of Cancer on Quality of Life. Florida: CRC Press; 1991. pp. 293–305.
    1. McCracken LM, Vowles KE, Eccleston C. Acceptance of chronic pain: component analysis and a revised assessment method. Pain. 2004;107(1–2):159–66. doi: 10.1016/j.pain.2003.10.012.
    1. Bond FW, Hayes SC, Baer RA, Carpenter KM, Orcutt HK, Waltz T, et al. Preliminary Psychometric properties of the Acceptance Action Questionnaire-II (AAQ-II): A revised measure of psychological flexibility and experiential avoidance. Behaviour Therapy. 2011;42:676–688. doi: 10.1016/j.beth.2011.03.007.
    1. Roland M, Morris R. A study of the natural history of back pain. Part 1: Development of a reliable and sensitive measure of disability in low-back pain. Spine. 1983;8(2):141–144. doi: 10.1097/00007632-198303000-00004.
    1. Ware JE, Kosinski M, Jr, Turner-Bowker DM, Gandek B. How to Score Version 2 of the SF-12v2® Health Survey (With a Supplement Documenting SF-12® Health Survey. Lincoln, RI: QualityMetric Incorporated; 2002.
    1. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67(6):361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. The EuroQol Group EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Dworkin RH, Turk DC. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113(1–2):9–19. doi: 10.1016/j.pain.2004.09.012.
    1. Guy W (Ed): ECDEU Assessment Manual for Psychopharmacology Department of Health, Education and Welfare publication (ADM). Rockville, USA: 1976
    1. Borkovec TD, Nau SD. Credibility of analogue therapy rationales. J Behav Ther Exp Psychiatry. 1972;34(4):257–260. doi: 10.1016/0005-7916(72)90045-6.
    1. Society TBP. Guidelines for Pain Management Programmes for Adults: An Evidence-Based Review on Behalf of The British Pain Society. London: The British Pain Society; 2013.
    1. Lancaster GA, Dodd S. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12. doi: 10.1111/j..2002.384.doc.x.
    1. Scottish Intercollegiate Guidelines Network . Management of Chronic Pain. Edinburgh: SIGN; 2001.
    1. Veehof MM, Oskam MJ, Schreurs KMG, Bohlmeijer ET. Acceptance-based interventions for the treatment of chronic pain: a systematic review and meta-analysis. Pain. 2011;152(3):533–542. doi: 10.1016/j.pain.2010.11.002.

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