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Open Access Study protocol

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

Frances Shawyer1, Graham N Meadows1*, Fiona Judd2, Paul R Martin3, Zindel Segal4 and Leon Piterman5

Author Affiliations

1 School of Psychology and Psychiatry, Monash University, Clayton Victoria 3800, Australia

2 Centre for Women's Mental Health, The Royal Women's Hospital, Parkville Victoria 3052 Australia

3 School of Applied Psychology, Griffith University, Mount Gravatt, Queensland, 4122, Australia

4 Centre for Addiction and Mental Health, Clarke Division, Toronto, Ontario, Canada, M6B-2H8

5 Office of the Pro Vice Chancellor, (Berwick & Peninsula), Monash University, Narre Warren Victoria 3805, Australia

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BMC Psychiatry 2012, 12:3  doi:10.1186/1471-244X-12-3

Published: 19 January 2012

Abstract

Background

Depression is a common condition that typically has a relapsing course. Effective interventions targeting relapse have the potential to dramatically reduce the point prevalence of the condition. Mindfulness-based cognitive therapy (MBCT) is a group-based intervention that has shown efficacy in reducing depressive relapse. While trials of MBCT to date have met the core requirements of phase 1 translational research, there is a need now to move to phase 2 translational research - the application of MBCT within real-world settings with a view to informing policy and clinical practice. The aim of this trial is to examine the clinical impact and health economics of MBCT under real-world conditions and where efforts have been made to assess for and prevent resentful demoralization among the control group. Secondary aims of the project involve extending the phase 1 agenda to an examination of the effects of co-morbidity and mechanisms of action.

Methods/Design

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.

Discussion

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: ACTRN12607000166471

Keywords:
Randomised controlled trial (RCT); Mindfulness-Based Cognitive Therapy (MBCT); Major Depressive Disorder; translational research; health economics