title: 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.
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.
  
  
  BACKGROUND
  ISRCTN43733490 , registered 15/12/2010.
authors.affiliation: Department of Psychology, University of London, Royal Holloway, Egham, TW20 0EX, Surrey, UK. t.pincus@rhul.ac.uk.
authors.forename: Tamar
authors.initials: T
authors.lastname: Pincus
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, LS2 9JT, Leeds, UK. s.t.anwar@leeds.ac.uk.
authors.forename: Shamaila
authors.initials: S
authors.lastname: Anwar
authors.affiliation: Health Psychology Section, Psychology Department, King's College, 5th Floor Bermondsey Wing, Guy's Campus, SE1 9RT, London, UK. lance.mccracken@kcl.ac.uk.
authors.forename: Lance M
authors.initials: LM
authors.lastname: McCracken
authors.affiliation: Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Charing Cross Hospital, W6 8RF, London, UK. a.mcgregor@imperial.ac.uk.
authors.forename: Alison
authors.initials: A
authors.lastname: McGregor
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, LS2 9JT, Leeds, UK. e.h.graham@leeds.ac.uk.
authors.forename: Liz
authors.initials: L
authors.lastname: Graham
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, LS2 9JT, Leeds, UK. m.collinson@leeds.ac.uk.
authors.forename: Michelle
authors.initials: M
authors.lastname: Collinson
authors.affiliation: Arthritis Research UK Primary Care Centre, Primary Care Sciences, Keele University, ST5 5BG, Keele, Staffordshire, UK. j.mcbeth@keele.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: McBeth
authors.affiliation: Department of Health Sciences, University of Leicester, LE5 4PW, Leicester, UK. pjw25@le.ac.uk.
authors.forename: Paul
authors.initials: P
authors.lastname: Watson
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, 101 Clarendon Road, LS2 9LJ, Leeds, UK. s.j.morley@leeds.ac.uk.
authors.forename: Stephen
authors.initials: S
authors.lastname: Morley
authors.affiliation: Department of Psychology, University of London, Royal Holloway, Egham, TW20 0EX, Surrey, UK. juliet.henderson@rhul.ac.uk.
authors.forename: Juliet
authors.initials: J
authors.lastname: Henderson
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, LS2 9JT, Leeds, UK. a.j.farrin@leeds.ac.uk.
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Farrin
mesh_terms: D000328:Adult; D000339:Affect; D059350:Chronic Pain / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D004185:Disability Evaluation; D004739:England; D005240:Feasibility Studies; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D055809:Illness Behavior; D017116:Low Back Pain / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D026741:Physical Therapy Modalities; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome