Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000761662
Ethics application status
Approved
Date submitted
21/11/2005
Date registered
22/11/2005
Date last updated
15/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing Relapse in Depression: the Mindfulness-Based Cognitive Therapy and Medication Alliance Therapy Project.
Scientific title
A randomised controlled pilot of mindfulness-based cognitive therapy and medication alliance therapy for the prevention of relapse and recurrence in depression in primary care
Universal Trial Number (UTN)
Trial acronym
MiMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent depression 917 0
Condition category
Condition code
Mental Health 984 984 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive Mindfulness-Based Cognitive Therapy (MBCT) and Medication Alliance Technology (MAT), singly and in combination.

The overall aim of this project is to establish and trial the methodology for a thorough investigation of the efficacy of two therapeutic interventions, Mindfulness-Based Cognitive Therapy (MBCT) and Medication Alliance Technology (MAT), singly and in combination, in the prevention of depressive relapse in people who have had at least two previous episodes of depression. This project is a complex study design (2x2 factorial) in which these two different treatments are delivered singly and in combination, and are compared against a treatment as usual control group.
The duration of the intervention is 14 months from randomisation to the different treatment conditions. This includes administration of 5 follow up questionnaires.
Intervention code [1] 769 0
Treatment: Other
Comparator / control treatment
The control is treatment as usual.

The duration of the intervention is 14 months from randomisation to the different treatment conditions. This includes administration of 5 follow up questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 1306 0
1/.Reduction in depressive relapse.
Key outcome variables and measures will include:
- rates of relapse and recurrence (defined as re-emergence of major depressive disorder according to DSM IV criteria as assessed by the Composite International Diagnostic Interview;
- the full CIDI will be used on entry to the project ; at follow-up administrations, the CIDI short form and the depressive disorders module will be administered;
- time to relapse (measured as above);
- mean depressive symptom ratings at followup points (assessed by the Hamilton Rating Scale for Depression; and the Beck Depression Inventory;
- disability / role functioning (assessed by the Work and Social Adjustment Scale; quality of life (assessed by the Australian Quality of Life measure; life satisfaction (taken from the International Wellbeing Index).
Timepoint [1] 1306 0
These measures will be administered at recruitment to the study; at eight weeks; and three monthly thereafter for the following 12 months, ie over approximately 14 months.
Primary outcome [2] 1307 0
2/.To establish and trial the methodology for a thorough investigation of the efficacy of two therapeutic interventions, MBCT and MAT, singly and in combination, in the prevention of depressive relapse in people who have had at least three previous episodes of depression.
Key outcome variables and measures will include:
- rates of relapse and recurrence (defined as re-emergence of major depressive disorder according to DSM IV criteria as assessed by the Composite International Diagnostic Interview;
- the full CIDI will be used on entry to the project ; at follow-up administrations, the CIDI short form and the depressive disorders module will be administered;
- time to relapse (measured as above);
- mean depressive symptom ratings at followup points (assessed by the Hamilton Rating Scale for Depression; and the Beck Depression Inventory;
- disability / role functioning (assessed by the Work and Social Adjustment Scale; quality of life (assessed by the Australian Quality of Life measure; life satisfaction (taken from the International Wellbeing Index).
Timepoint [2] 1307 0
These measures will be administered at recruitment to the study; at eight weeks; and three monthly thereafter for the following 12 months, ie over approximately 14 months.
Secondary outcome [1] 2339 0
Participants receiving MBCT and/or MAT will be less likely to experience depressive relapse within 12 months than those who receive usual clinical management
Timepoint [1] 2339 0
These measures will be administered at recruitment to the study; at eight weeks; and three monthly thereafter for the following 12 months, ie over approximately 14 months.
Secondary outcome [2] 2340 0
Participants receiving MBCT and MAT in combination will be less likely to experience depressive relapse within 12 months than participants receiving either one of these interventions alone.
Timepoint [2] 2340 0
These measures will be administered at recruitment to the study; at eight weeks; and three monthly thereafter for the following 12 months, ie over approximately 14 months.
Secondary outcome [3] 2341 0
Participants receiving MAT will demonstrate greater adherence to prescribed medication and attendance at scheduled appointments than others.
Timepoint [3] 2341 0
These measures will be administered at recruitment to the study; at eight weeks; and three monthly thereafter for the following 12 months, ie over approximately 14 months.
Secondary outcome [4] 2342 0
Efficacy of MBCT in reducing depressive relapse is mediated by an increase in mindfulness.
Timepoint [4] 2342 0
These measures will be administered at recruitment to the study; at eight weeks; and three monthly thereafter for the following 12 months, ie over approximately 14 months.
Secondary outcome [5] 2343 0
Efficacy of MAT in reducing depressive relapse is mediated by an increase in adherence.
Timepoint [5] 2343 0
These measures will be administered at recruitment to the study; at eight weeks; and three monthly thereafter for the following 12 months, ie over approximately 14 months.

Eligibility
Key inclusion criteria
Prescribed antidepressant medication or not;Ability to speak and read English fluently;Meeting DSM-IV TR criteria for three previous major depressive episodes; at least two of which must have occurred within the past five years, and one within the past two years.At assessment, score on the Hamilton Rating Scale for Depression of less than 10.At assessment, score with respect to antidepressant medication on the Adherence Scale of 5 or less.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of schizophrenia or schizoaffective disorder, bipolar disorder or cyclothymia;Current eating disorder or obsessive-compulsive disorder;Organic mental disorder or pervasive developmental delay;Current borderline or antisocial personality disorder;Current psychotherapy or counselling greater than or equal to once per week;Current practice of meditation more than once per week or yoga more than twice per week;Active medical illness to which depression is secondary.

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)
The allocation was concealed by giving the unique ID numbers to the statistician via central network computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment Groups: the statistician has used the method of minimization to allocate patients to treatment group within stratum. The computer program used is MINIM: Minimisation program for allocating patients to treatments in clinical trials, written by Stephen Evans, Simon Day and Patrick Royston, from the Department of Clinical Epidemiology at London Hospital Medical School. The version used on 10 October 2005 was Version 1.5/28-3-90.Treatment Groups: MiMA 4-arm Trial: This is a factorial 2x2 trial, with two factors: MBCT (yes/no) and MAT (yes/no). Thus there are to be four groups, with approximately equal numbers in each group. I have assigned numeric codes to the four groups as follows: 0: usual management (neither MBCT or MAT); 1: Medication Alliance Therapy (MAT) alone; 2: Mindfullness-based cognitive therapy (MBCT) alone; 3: MAT and MBCT in combination. MiMA 2-arm trial: For patients ineligible for MiMA4, some may be eligible for MiMA2, which has two arms, testing MBCT against Usual Management alone. Codes as above (0 and 2 only). Stratification: There is one stratification variable required for MiMA4: source of referral, which is binary - either GP or specialist. For MiMA2, there are two unequally weighted stratifying factors: 1. Current medication (yes/no), and 2. Source of referral (GP/specialist).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Randomisation Strategy: Participants will be randomised to one of four conditions, Mindfulness-based cognitive therapy (MBCT), Medication alliance therapy (MAT), MBCT and MAT combined, and Treatment as usual. People either not prescribed or fully compliant with medication will have their randomisation options restricted to either Mindfulness-Based Cognitive Therapy or Treatment As Usual, because Medication Alliance Technology is not relevant to their situation.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1081 0
Charities/Societies/Foundations
Name [1] 1081 0
Beyondblue, Victorian Centre of Excellence in Depression and Related Disorders
Country [1] 1081 0
Australia
Primary sponsor type
University
Name
Southern Synergy The Southern Health Adult Psychiatry Research, Training, & Evaluation Centre Monash University www.med.monash.edu.au/psychmed/units/southernsynergy
Address
Dandenong Hospital PO Box 956 93 David St Dandenong VIC 3175
Country
Australia
Secondary sponsor category [1] 942 0
None
Name [1] 942 0
nil
Address [1] 942 0
Country [1] 942 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2384 0
Southern Health;
Ethics committee address [1] 2384 0
Ethics committee country [1] 2384 0
Australia
Date submitted for ethics approval [1] 2384 0
Approval date [1] 2384 0
Ethics approval number [1] 2384 0
Ethics committee name [2] 2385 0
Monash University;
Ethics committee address [2] 2385 0
Ethics committee country [2] 2385 0
Australia
Date submitted for ethics approval [2] 2385 0
Approval date [2] 2385 0
Ethics approval number [2] 2385 0
Ethics committee name [3] 2386 0
University of Wollongong
Ethics committee address [3] 2386 0
Ethics committee country [3] 2386 0
Australia
Date submitted for ethics approval [3] 2386 0
Approval date [3] 2386 0
Ethics approval number [3] 2386 0

Summary
Brief summary
In this pilot study, adult consumers attending primary care, the private sector and Southern Mental Health Services,
who have had recurrent major depression will be randomised to one of four conditions:
1. Mindfulness-based cognitive therapy (MBCT)
2. Medication alliance therapy (MAT)
3. MBCT and MAT combined, and
4. Treatment as usual.
Randomisation Strategy: Participants will be randomised to one of the four conditions. People either not prescribed or fully compliant with medication will have their randomisation options restricted to either Mindfulness-Based Cognitive Therapy or Treatment As Usual, because Medication Alliance Technology is not relevant to their situation.
MBCT will be delivered by clinical psychologists trained according to the MBCT manual modified for an Australian context.
MAT will be administered by community health staff, eg practice nurses, trained according to a manual developed by the research group.
The research evaluation is at three levels:
A. Examination of the feasibility of delivery of training programs and interventions within the Australian primary care context.
B. Evaluation of the MBCT and MAT training packages, for which the participating therapists will be engaged also as study participants.
C. Participating consumers will be regularly assessed over 12 months with systematic interviews assessing depression and disability as outcomes, and also mindfulness and adherence as possible mediating factors in the effects of these two therapies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36044 0
Address 36044 0
Country 36044 0
Phone 36044 0
Fax 36044 0
Email 36044 0
Contact person for public queries
Name 9958 0
Professor Graham Meadows
Address 9958 0
Southern Synergy
The Southern Health Adult Psychiatry Research, Training and Evaluation Centre
Monash University
Dandenong Hospital
PO Box 956
93 David St
Dandenong VIC 3175
Country 9958 0
Australia
Phone 9958 0
+61 3 95541847
Fax 9958 0
+61 3 95541955
Email 9958 0
[email protected]
Contact person for scientific queries
Name 886 0
Professor Graham Meadows
Address 886 0
Southern Synergy
The Southern Health Adult Psychiatry Research Training and Evaluation Centre
Monash University
Dandenong Hospital
PO Box 956
93 David St
Dandenong VIC 3175
Country 886 0
Australia
Phone 886 0
+61 3 95541847
Fax 886 0
+61 3 95541955
Email 886 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.