Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial

Abstract

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

STEP.De study—a multicentre cluster-randomised effectiveness trial of exercise therapy for patients with depressive symptoms in healthcare services: study protocol

“…This is close to but slightly higher than the minimal important difference of 0.24 suggested by Cuijpers et al 6 for use in depression trials. The slight liberalisation is supported by similar margins of about 0.3 to 0.4*SD in other trials on activity-related treatment of depression (eg, 0.35*SD in Rhodes et al 46 ; 0.39*SD in Richards et al 47 ). Moreover, it accounts for the possibility that effect sizes in exercise therapy might specifically depend on individual patient indication and hence the criterion for non-inferiority was chosen not too conservative.…”

Training Clinicians to Deliver Evidence-Based Psychotherapy: Development of the Training in Psychotherapy (TIP) Tool

“…It may be that the importance of certain training elements varies by psychotherapy. For example, an approach like behavioral activation may require less-intensive training than a more complex psychotherapy, such as acceptance and commitment therapy (Jacobson, Martell, and Dimidjian, 2001;Rhodes et al, 2014) or CBT. It is also important to note that our review of the literature was limited to psychotherapies with a strong evidence base; therefore, we did not consider the topic of the training (i.e., which psychotherapy was being trained) as a potential domain for the tool.…”

Enhanced psychological care in cardiac rehabilitation services for patients with new-onset depression: the CADENCE feasibility study and pilot RCT

“…It is noteworthy that both review teams noted that the methodological quality of selected studies was low and that there remains some uncertainty regarding the effectiveness of BA, 47,48 particularly with regard to the longer-term outcomes. 47 However, a very recent National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme-funded non-inferiority RCT [the Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA) trial] 49 comparing BA with CBT has shown that BA is not inferior to CBT for the treatment of depression. 50 In this trial, which randomised 440 participants to BA or CBT, 66% of participants receiving BA or CBT were recovered from depression at 12 months post randomisation, with benefits extending to the same degree at the long-term 18-month follow-up point.…”