• Shelley Rhodes, David A Richards, David Ekers, Dean McMillan, Sarah Byford, Paul A Farrand, Simon Gilbody, Steven D Hollon, Willem Kuyken, Christopher Martell, Heather A O'Mahen, Emer O'Neill, Nigel Reed, Rod S Taylor, Ed R Watkins, and Kim A Wright.
• University of Exeter Medical School, St Luke's Campus, Exeter EX1 2 LU, UK. d.a.richards@exeter.ac.uk.
• Trials. 2014 Jan 1;15:29.

BackgroundCognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Behavioural activation (BA) is a psychological treatment for depression that may be an effective alternative to CBT and, because it is simpler, might also be delivered by less highly trained and specialised mental health workers.Methods/DesignCOBRA is a two-arm, non-inferiority, patient-level randomised controlled trial, including clinical, economic, and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT. Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care. We will analyse for non-inferiority in per-protocol and intention-to-treat populations. Our primary outcome will be severity of depression symptoms (Patient Health Questionnaire-9) at 12 months follow-up. Secondary outcomes will be clinically significant change and severity of depression at 18 months, and anxiety (General Anxiety Disorder-7 questionnaire) and health-related quality of life (Short-Form Health Survey-36) at 12 and 18 months. Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions, health and social care services used, plus productivity losses. Cost-effectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life.DiscussionThe clinical and economic outcomes of this trial will provide the evidence to help policy makers, clinicians and guideline developers decide on the merits of including BA as a first-line treatment of depression.Trial RegistrationCurrent Controlled Trials ISRCTN27473954.

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