title: Trauma-focused cognitive behaviour therapy and exercise for chronic whiplash: protocol of a randomised, controlled trial.
abstract: BACKGROUND
  As a consequence of a road traffic crash, persistent pain and disability following whiplash injury are common and incur substantial personal and economic costs. Up to 50% of people who experience a whiplash injury will never fully recover and up to 30% will remain moderately to severely disabled by the condition. The reason as to why symptoms persist past the acute to sub-acute stage and become chronic is unclear, but likely results from complex interactions between structural injury, physical impairments, and psychological and psychosocial factors. Psychological responses related to the traumatic event itself are becoming an increasingly recognised factor in the whiplash condition. Despite this recognition, there is limited knowledge regarding the effectiveness of psychological interventions, either delivered alone or in combination with physiotherapy, in reducing the physical and pain-related psychological factors of chronic whiplash. Pilot study results have shown positive results for the use of trauma-focused cognitive behaviour therapy to treat psychological factors, pain and disability in individuals with chronic whiplash. The results have indicated that a combined approach could not only reduce psychological symptoms, but also pain and disability.
  
  
  OBJECTIVE
  The primary aim of this randomised, controlled trial is to investigate the effectiveness of combined trauma-focused cognitive behavioural therapy, delivered by a psychologist, and physiotherapy exercise to decrease pain and disability of individuals with chronic whiplash and post-traumatic stress disorder (PTSD). The trial also aims to investigate the effectiveness of the combined therapy in decreasing post-traumatic stress symptoms, anxiety and depression.
  
  
  METHODS
  A total of 108 participants with chronic whiplash-associated disorder (WAD) grade II of > 3 months and < 5 years duration and PTSD (diagnosed with the Clinician Administered PTSD Scale (CAPS) according to the DSM-5) will be recruited for the study. Participants will be assessed via phone screening and in person at a university research laboratory. Interventions will take place in southeast Queensland, Australia and southern Denmark.
  
  
  METHODS
  Psychological therapy will be delivered once a week over 10 weeks, with participants randomly assigned to either trauma-focused cognitive behavioural therapy or supportive therapy, both delivered by a clinical psychologist. Participants will then receive ten sessions of evidence-based physiotherapy exercise delivered over a 6-week period.
  
  
  METHODS
  The primary outcome measure is neck disability (Neck Disability Index). Secondary outcomes focus on: pain intensity; presence and severity of PTSD (CAPS V and PTSD Checklist 5); psychological distress (Depression, Anxiety Stress Scale 21); patient perceived functionality (SF-12, Tampa Scale of Kinesiophobia, and Patient-Specific Functional Scale); and pain-specific self-efficacy and catastrophising (Pain Self-Efficacy Questionnaire and Pain Catastrophizing Scale). After psychotherapy (10 weeks after randomisation) and physiotherapy (16 weeks after randomisation), as well as at the 6-month and 12-month follow-ups, a blind assessor will measure the outcomes.
  
  
  METHODS
  All analyses will be conducted on an intention-to-treat basis. The primary and secondary outcomes that are measured will be analysed using linear mixed and logistic regression models. Any effect of site (Australia or Denmark) will be evaluated by including a site-by-treatment group-by-time interaction term in the mixed models analyses. Effect modification will only be assessed for the primary outcome of the Neck Disability Index.
  
  
  CONCLUSIONS
  This study will provide a definitive evaluation of the effects of adding trauma-focused cognitive behaviour therapy to physiotherapy exercise for individuals with chronic WAD and PTSD. This study is likely to influence the clinical management of whiplash injury and will have immediate clinical applicability in Australia, Denmark and the wider international community. The study will also have implications for both health and insurance policy makers in their decision-making regarding treatment options and funding.
authors: Menzies Health Institute Queensland, Centre for National Research on Disability and Rehabilitation Medicine (CONROD), NHMRC CRE in Recovery Following Road Traffic Injury, Griffith University, Gold Coast.
authors: Letitia
authors: L
authors: Campbell
authors: CONROD, University of Queensland; School of Psychology, University of Queensland, Brisbane, Australia.
authors: Justin
authors: J
authors: Kenardy
authors: Department of Psychology, University of Southern Denmark, Odense, Denmark.
authors: Tonny
authors: T
authors: Andersen
authors: Menzies Health Institute Queensland, Centre for National Research on Disability and Rehabilitation Medicine (CONROD), NHMRC CRE in Recovery Following Road Traffic Injury, Griffith University, Gold Coast.
authors: Leanne
authors: L
authors: McGregor
authors: Menzies Health Institute Queensland, Centre for National Research on Disability and Rehabilitation Medicine (CONROD), NHMRC CRE in Recovery Following Road Traffic Injury, Griffith University, Gold Coast.
authors: Annick
authors: A
authors: Maujean
authors: Menzies Health Institute Queensland, Centre for National Research on Disability and Rehabilitation Medicine (CONROD), NHMRC CRE in Recovery Following Road Traffic Injury, Griffith University, Gold Coast.
authors: Michele
authors: M
authors: Sterling
mesh_terms: D000328:Adult; D001315:Australia; D058443:Catastrophization / Q000523:psychology / Q000628:therapy; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D004185:Disability Evaluation; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D010147:Pain Measurement / Q000379:methods; D012107:Research Design; D014911:Whiplash Injuries / Q000523:psychology / Q000628:therapy*