Introduction and Synopsis of the Dare Project

The Synergy Group led the development of a grant application to the National Health and Medical Research Council, drawing on the experience from the MiMA project in relation to MBCT, and submitted it for consideration in the 2007 funding round. This application was successful and work began on the project in 2007. Some details of the project follow:

Investigators:
Chief Investigators:
Professors Graham Meadows, Fiona Judd, Paul Martin, Zindel Segal, and Leon Piterman

Associate Investigators
Professors Michael Berk, Jayashri Kulkarni, Mark Oakley Browne and Alan Shiell, Associate Professors David Clarke, Saji Damodaran, Damien Jolley and Richard Newton, Dr Gavin Sullivan, Anthony Cichello, Ingrid Ozols and Bob Sharples.

Project Staff
Dr Fran Shawyer, Annette Graham, Bernadette O'Grady, Debbie Lang.

Project Sites:

• Melbourne - CBD, inner and outer southern districts (Alfred Hospital, Melbourne; The Victoria Clinic, Prahran; Dandenong Hospital, Dandenong)
• Geelong (The Geelong Clinic, St Albans Park)
• Mornington Peninsula (Frankston Hospital, Frankston).

Grant Synopsis:

Title

A Comparison of Mindfulness-Based Cognitive Therapy with Usual Treatment plus Active Symptom Monitoring for Preventing Relapse in People Who Have Had Recurrent Depression.

Background

Relapse rates for major depressive disorder (MDD) increase with increased number of prior episodes so relapse prevention should be a priority for people who have already suffered several episodes. Even with guideline-based pharmacotherapy relapse is not uncommon so there is a need for non-pharmacological approaches to relapse prevention. Mindfulness-Based Cognitive Therapy (MBCT) combines cognitive therapy and mindfulness meditation in an eight-week group instruction course delivered as post-acute phase therapy for relapse prevention of major depression. Randomised controlled trial (RCT) results from Canada and the United Kingdom indicate that MBCT reduces relapse among recovered depressed patients, particularly those with three or more prior depressive episodes, but there is a need for further development of the empirical base for MBCT including effectiveness studies in varied settings.

Aims

The primary aim of this project is to determine if MBCT when added to existing treatment as usual plus regular monitoring of symptoms (depression relapse – active monitoring – DRAM) is more effective than DRAM in preventing depressive relapse in people who have had at least three prior episodes of depression. The project will investigate the applicability and effectiveness of MBCT as assessed in multiple and varied real world settings.

The secondary aim of the project is to provide for a detailed examination of the mechanisms by which this form of therapy may prevent depressive relapse, with this examination structured in a way so as also to progress the understanding of the clinical applicability of MBCT as a treatment for relapse prevention in depression.

Research Plan

The main study will be a multi-site effectiveness study in the nature of a pragmatic quantitative RCT with stratified groups including conditions of MBCT and DRAM, all with usual medication encouraged and adherence monitored. Enrolled participants will have had 3+depressive episodes and be in remission from this disorder. Power considerations suggest recruiting at least 344 people to interview. This will be assisted by the multi-site design including mental health facilities from Barwon Health, Bayside Health, Bendigo Health, Latrobe Valley Regional Hospital, Peninsula Health, and Southern Health.

Time to relapse of major depressive disorder, time spent in relapse, and levels of depressive symptomatology will be assessed by structured and validated instruments, also psychiatric comorbidities, social functioning, quality of life, health service utilisation and medication adherence. Candidate mediators examined will include mindfulness, rumination, neuroticism, openness to experience and time spent in meditation practice. Measurement of incremental cost-utility of treatment will adopt a social perspective with results subject to extensive probabilistic sensitivity testing.

A parallel small exploratory grounded-theory based qualitative interview study will seek to identify previously unconsidered relationships between medication, mindfulness practice and clinical outcomes.

Outcomes and significance

This first major MBCT study from outside the therapy development group will address the internationally important issue of transferability of the technique, will enhance understandings of mechanisms of action and importantly will establish effectiveness in combination with medication. Cost utility analysis will enable specific policy recommendations for Australia. Findings from this study would lead to MBCT having a high degree of evidence-based support examining its use, so that it could be considered as an intervention for which 'high', rather than 'moderate', levels of evidence exist. Hence this study if positive would provide internationally significant findings to support consideration of inclusion of this treatment into guidelines for routine clinical management of the serious and disabling problem of recurrent depression.