None listed
Conditions
Brief summary
More than one in twenty Australians experience depression in a single year and it is commonly a relapsing disorder. At least 60% of people who have had a depressive episode will have another, the vast majority within two years of the index episode. For those who have had three episodes, the relapse rate is 90%. Even with guideline-based pharmacotherapy relapse is not uncommon so there is a need for non-pharmacological approaches to relapse prevention. The economic burden of depression in Australia has been estimated as perhaps 2.8 billion annually. Mindfulness-based cognitive therapy (MBCT) is an innovative psychological treatment, combining principles of cognitive therapy and mindfulness meditation. It is designed to prevent relapse in people who have recovered from depressive episodes. MBCT aims to teach people to become more aware of, and to related differently to, their thoughts, feelings and bodily sensations; in particular, to view these thoughts and feelings as passing events in the mind rather than identifying with them. Through gaining these skills in increased awareness of thoughts and feelings, participants in the treatment learn to avoid negative ruminations, which have a powerful role in triggering relapses of depression. This project will examine the effectiveness of MBCT for the first time in Australians with a history of recurring depression. The primary aim of this project is to determine if MBCT when added to existing treatment as usual (TAU) is more effective than TAU in preventing depressive relapse over a two-year period in people who have had at least three prior episodes of depression. The study also aims to establish whether the mechanisms by which MBCT is proposed to work – by decreasing rumination, increasing levels of mindfulness and self-awareness – do in fact operate. We also hope to establish whether MBCT also has any impact on anxiety, another disabling condition that commonly occurs with depression. Cost utility analysis will enable specific policy recommendations for Australia. Positive 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, if outcomes are positive, this study 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.
Interventions
This study is a randomised controlled trial, whereby participants will be randomised to mindfulness-based cognitive therapy (MBCT) or treatment as usual (TAU).
Mindfulness-based cognitive therapy (MBCT) is a manualised group based intervention designed to reduce rates of relapse of MDD. It integrates aspects of cognitive therapy with components of a mindfulness-based stress reduction program. It teaches clients to become more aware of, and to relate differently to, thoughts, feelings and bodi
This study is a randomised controlled trial, whereby participants will be randomised to mindfulness-based cognitive therapy (MBCT) or treatment as usual (TAU). Mindfulness-based cognitive therapy (MBCT) is a manualised group based intervention designed to reduce rates of relapse of MDD. It integrates aspects of cognitive therapy with components of a mindfulness-based stress reduction program. It teaches clients to become more aware of, and to relate differently to, thoughts, feelings and bodily sensations; in particular, to view thoughts and feelings as passing events in the mind rather than as necessarily reflecting reality. The program teaches skills in disengagement from habitual (automatic) dysfunctional cognitive routines, especially depression-related ruminative thought patterns. Its efficacy in doing this has been demonstrated in two randomised controlled trials. It is now included in the UK Government’s National Institute of Clinical Excellence (NICE) Guidelines for prevention of depressive recurrence for patients who have suffered three or more episodes of depression. It has not been similarly recommended in other countries. After an initial individual orientation session the MBCT program is delivered by an instructor in eight weekly 2 hour group training sessions involving up to 10 clients. Optional ‘booster sessions’ will be available on a 3-monthly basis following completion of the core program. Sessions incorporate mindfulness practices including meditation and also cognitive-behavioural therapy exercises. Homework for participants includes formal daily meditation practices and exercises for the development of mindful awareness within everyday activity. Emphasis later in the course is on combining cognitive-behaviour therapy (CBT) techniques such as conventional CBT activity scheduling with meditative practices into synergistic strategies for responding to negative mood states. Finally the course participants develop personal documentation detailing warning signs and related action plans, as well as considering how to maintain practices and habits they have found helpful.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Ability to speak and read English fluently; and meeting DSM-IV criteria for three previous major depressive episodes.
Exclusion criteria
A current episode of MDD; current symptoms of a psychotic disorder, or a past diagnosis of a psychotic disorder where the treating clinician believes the therapy may be contraindicated; current significant eating disorder or obsessive-compulsive disorder, organic mental disorder or pervasive developmental delay; current borderline or antisocial personality disorder; current alcohol or drug dependency other than tobacco; or current benzodiazepine intake of more than 20mg diazepam equivalent a day.
Outcome results
None listed