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Trial registered on ANZCTR


Registration number
ACTRN12607000166471
Ethics application status
Approved
Date submitted
8/03/2007
Date registered
12/03/2007
Date last updated
30/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Mindfulness-Based Cognitive Therapy Compared to Treatment-as-usual for Preventing Depressive Relapse in Subjects at Very High Risk
Scientific title
In people who have had at least three prior episodes of major depressive disorder is mindfulness based cognitive therapy more effective than treatment as usual in preventing relapse of major depression.
Secondary ID [1] 348 0
NHMRC Grant: 436897
Universal Trial Number (UTN)
Trial acronym
Depression Awareness Recovery Effectiveness (DARE)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 1673 0
Condition category
Condition code
Mental Health 1776 1776 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1641 0
Prevention
Comparator / control treatment
The control condition will be treatment as usual. Participants will be encouraged to attend their regular treating practitioner(s) as they would if they were not involved in the trial. Also, both MBCT and treatment as usual groups are encouraged to use their regular research data monitoring of depressive symptoms as an aid to early recognition of relapse of MDD and to seek usual care if indicated in a process described as Depression Relapse Active Monitoring (DRAM). Antidepressant medication and other psychological interventions will be permitted in both arms of the trial if treating practitioners consider necessary. Such interventions will be monitored through collection of service contact information in both groups.
Control group
Active

Outcomes
Primary outcome [1] 2483 0
Relapse of Major Depressive Disorder (MDD).
Timepoint [1] 2483 0
Two year follow up following MBCT group, so approximately 26 months total for both groups. Status monitored with short questionnaire monthly, more extensive questionnaires three monthly and face to face interviews after 14 and 26 months.
Secondary outcome [1] 4265 0
Time to relapse of MDD
Timepoint [1] 4265 0
Monthly
Secondary outcome [2] 4266 0
Time to clinical intervention for MDD
Timepoint [2] 4266 0
Monthly
Secondary outcome [3] 4267 0
Length of time spent in depressive episodes
Timepoint [3] 4267 0
Based on monthly responses and also yeaarly interviews
Secondary outcome [4] 4268 0
Anxiety symptoms
Timepoint [4] 4268 0
Three monthly
Secondary outcome [5] 4269 0
Quality of life
Timepoint [5] 4269 0
Three monthly
Secondary outcome [6] 4270 0
Social functioning
Timepoint [6] 4270 0
Three monthly
Secondary outcome [7] 4271 0
Health care costs
Timepoint [7] 4271 0
Annual review
Secondary outcome [8] 4272 0
Adherence to routinely prescribed antidepressant medication.
Timepoint [8] 4272 0
Three monthly
Secondary outcome [9] 4273 0
Rumination
Timepoint [9] 4273 0
Three monthly
Secondary outcome [10] 4274 0
Neuroticism
Timepoint [10] 4274 0
Three monthly
Secondary outcome [11] 4275 0
Open-ness to experience
Timepoint [11] 4275 0
Three monthly

Eligibility
Key inclusion criteria
Ability to speak and read English fluently; and meeting DSM-IV criteria for three previous major depressive episodes.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolment will be through face to face interview with a researcher at which point informed consent will be invited. Allocation to treatment will be by a statistician in another centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified and using computer software, stratification according to gender, status in regards to prescribed medication and referral origin (Primary or Specialist services)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessors will as far as possible be blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
196
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1926 0
Government body
Name [1] 1926 0
National Health and Medical Research Council (Grant number: 436897)
Country [1] 1926 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University, Clayton 3800
Country
Australia
Secondary sponsor category [1] 1738 0
Hospital
Name [1] 1738 0
Southern Health
Address [1] 1738 0
Clayton Campus
246 Clayton Road, Clayton.
Victoria 3168
Country [1] 1738 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3584 0
Southern Health
Ethics committee address [1] 3584 0
Ethics committee country [1] 3584 0
Australia
Date submitted for ethics approval [1] 3584 0
Approval date [1] 3584 0
21/05/2007
Ethics approval number [1] 3584 0
07056B
Ethics committee name [2] 3585 0
Alfred Hospital Ethics Committee
Ethics committee address [2] 3585 0
Ethics committee country [2] 3585 0
Australia
Date submitted for ethics approval [2] 3585 0
Approval date [2] 3585 0
19/03/2008
Ethics approval number [2] 3585 0
280/07
Ethics committee name [3] 3586 0
Barwon Health
Ethics committee address [3] 3586 0
Ethics committee country [3] 3586 0
Australia
Date submitted for ethics approval [3] 3586 0
Approval date [3] 3586 0
21/02/2008
Ethics approval number [3] 3586 0
07/86
Ethics committee name [4] 3587 0
Peninsula Health
Ethics committee address [4] 3587 0
Ethics committee country [4] 3587 0
Australia
Date submitted for ethics approval [4] 3587 0
Approval date [4] 3587 0
16/01/2008
Ethics approval number [4] 3587 0
2007/53
Ethics committee name [5] 5235 0
Monash University Standing Committee on Ethics in Research involving Humans.
Ethics committee address [5] 5235 0
Monash University, Vic 3800
Ethics committee country [5] 5235 0
Australia
Date submitted for ethics approval [5] 5235 0
Approval date [5] 5235 0
03/07/2007
Ethics approval number [5] 5235 0
CF07/1275-2007/0191MCC

Summary
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.
Trial website
www.dare.org.au
Trial related presentations / publications
Publication. Shawyer, F., Meadows, G.N., Judd, F., Martin, P.R., Segal, Z., Piterman, L. (2012). 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. BMC Psychiatry, 12, 3.

Oral presentation. Shawyer, F., Meadows, G., Judd, F., Martin, P., Segal, Z., Piterman, L. Findings from the DARE study, a multisite study of MBCT with two year follow up, focusing on subgroups and time course. 10th Annual International Scientific Conference for Clinicians, Researchers and Educators: Investigating and Integrating Mindfulness in Medicine, Health Care and Society 28 March – 1 April 2012, Norwood, USA.

Poster presentation. Shawyer, F., Meadows, G., Judd, F., Martin, P., Segal, Z., Piterman, L. A randomised controlled trial of mindfulness-based cognitive therapy: study protocol and design highlighting phase 1 and phase 2 translational research elements. 10th Annual International Scientific Conference for Clinicians, Researchers and Educators: Investigating and Integrating Mindfulness in Medicine, Health Care and Society 28 March – 1 April 2012, Norwood, USA.

Oral presentation. Prowse, P., Meadows, G., Shawyer, F., Segal, Z. An exploratory study into the effectiveness of fidelity scales in the delivery of Mindfulness-Based Cognitive Therapy as part of the Depression Awareness Recovery Effectiveness (DARE) Program in Australia. 10th Annual International Scientific Conference for Clinicians, Researchers and Educators: Investigating and Integrating Mindfulness in Medicine, Health Care and Society 28 March – 1 April 2012, Norwood, USA.

Oral presentation. Meadows, G., Shawyer, F., Özmen, M., Judd, F., Martin, P., Segal, Z., Piterman, L. Introducing the DARE study, a multisite study of MBCT with two year follow up and including health economic evaluation. 10th Annual International Scientific Conference for Clinicians, Researchers and Educators: Investigating and Integrating Mindfulness in Medicine, Health Care and Society 28 March – 1 April 2012, Norwood, USA.

Oral presentation. Shawyer, F., Meadows, G., Judd, F., Piterman, L, Martin, P., Segal, Z., Piterman, L. Mindfulness-Based Cognitive Therapy for preventing relapse in recurrent depression: outcomes from the first year follow up of a randomised controlled trial. 34th Australian Association for Cognitive & Behaviour Therapy National Conference 26-30 October 2011, Sydney, Australia.

Oral presentation. Shawyer, F., Meadows, G., Judd, F., Martin, P., Segal, Z., Piterman, L. Preliminary findings from a randomized controlled trial of Mindfulness-based cognitive therapy for recurrent depression. 27th International Congress of Applied Psychology, 11-16 July 2010, Melbourne, Australia.

Poster presentation. Shawyer, F., Meadows, G., Judd, F., Martin, P., Segal, Z., Piterman, L. Does mindfulness-based cognitive therapy improve awareness and reduce rumination in recurrent depression and, if so, does antidepressant medication help? World Congress of Behavioral and Cognitive Therapies, June 2-5 2010, Boston, USA.

Poster presentation. Meadows, G., Shawyer, F., Graham, A. An exploratory effectiveness study with MBCT: findings and design issues. Investigating and Integrating Mindfulness in Medicine, Health Care and Society. 8th Annual International Scientific Conference. April 7-11 2010, Worcester, Massachusetts, USA.
Public notes

Contacts
Principal investigator
Name 27575 0
Address 27575 0
Country 27575 0
Phone 27575 0
Fax 27575 0
Email 27575 0
Contact person for public queries
Name 10830 0
Professor Graham Meadows
Address 10830 0
Southern Synergy, Monash University Notting Hill Campus, c/- Wellington Rd Clayton, Victoria 3800
Country 10830 0
Australia
Phone 10830 0
613 99029696
Fax 10830 0
613 9902 9900
Email 10830 0
[email protected]
Contact person for scientific queries
Name 1758 0
Professor Graham Meadows
Address 1758 0
Southern Synergy, Monash University Notting Hill Campus, c/- Wellington Rd Clayton, Victoria 3800
Country 1758 0
Australia
Phone 1758 0
613 99029696
Fax 1758 0
613 9902 9900
Email 1758 0
[email protected]

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