The DARE study of relapse prevention in depression: design for a phase 1/2 translational randomised controlled trial involving mindfulness-based cognitive therapy and supported self monitoring

This study is designed as a prospective, multi-site, single-blind, randomised controlled trial using a group comparison design between involving the intervention, MBCT, and a self-monitoring comparison condition, Depression Relapse Active Monitoring (DRAM). Follow-up is over 2 years. The design of the study indicates recruitment from primary and secondary care of 204 participants who have a history of 3 or more episodes of Major Depression but who are currently well. Measures assessing depressive relapse/recurrence, time to first clinical intervention, treatment expectancy and a range of secondary outcomes and process variables are included. A health economics evaluation will be undertaken to assess the incremental cost of MBCT.The results of this trial, including an examination of clinical, functional and health economic outcomes, will be used to assess the role that this treatment approach may have in recommendations for treatment of depression in Australia and elsewhere. If the findings are positive, we expect that this research will consolidate the evidence base to guide the decision to fund MBCT and to seek to promote its availability to those who have experienced at least 3 episodes of depression.Australian New Zealand Clinical Trials Registry: ACTRN12607000166471The 1 year prevalence of major depressive disorder (MDD) in Australia has consistently been measured above 4% [1,2] and it is commonly a recurrent condition. At least 60% of people who have had one major depressive episode will have another, mostly within 2 years of the index episode [3]. Seventy percent of those who have had two episodes will have a third, and 90% of those with three episodes will have a fourth [4]. Effective interventions targeting relapse, particularly in people with a history of three or more episodes of depression, could dramatically reduce the point prevalence of the condition [5]. Mindfulness-based cognitive therapy (MBCT) is a group-based program that integrates aspects of cog