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Trial registered on ANZCTR


Registration number
ACTRN12611000804987
Ethics application status
Approved
Date submitted
5/07/2011
Date registered
1/08/2011
Date last updated
15/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The COMET study: Metacognitive Therapy and Cognitive Behaviour Therapy for Depression
Scientific title
Will Metacognitive Therapy be more effective and act more quickly than Cognitive Behaviour Therapy in reducing depressive symptoms in outpatients with depression?
Secondary ID [1] 262568 0
Nil
Universal Trial Number (UTN)
Trial acronym
The COMET study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder 4834 0
Condition category
Condition code
Mental Health 237177 237177 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive 12 weeks of individual therapy;either Metacognitive therapy(MCT) or cognitive behaviour therapy (CBT). Most participants will receive 12 sessions in 12 weeks with 6 sessions in the first 4 weeks however the range permissible is 8 to 15 sessions over the 12 weeks. Therapy sessions last up to 1 hr. Clinical psychologists deliver both therapies and follow the work of AT Beck and J Beck for CBT(1,2) and of Adrian Wells and Costas Papageorgiou for MCT (3,4).

References
1. Beck AT, Rush AJ, Shaw BF, Emery G. Cognitive therapy of depression. Guildford Press, New York,1979.
2. Beck JS. Cognitive therapy: basics and beyond. The Guilford Press, New York, 1995.
3. Wells A. Metacognitive Therapy for Anxiety and Depression The Guilford Press; 2009.
4. Papageorgiou C, Wells A, eds. Depressive rumination: nature, theory and treatment. John Wiley, West Sussex, England, 2004.
Intervention code [1] 4613 0
Treatment: Other
Intervention code [2] 267036 0
Behaviour
Comparator / control treatment
Cognitive behaviour therapy
Control group
Active

Outcomes
Primary outcome [1] 237995 0
Reduction in depressive symptoms at end treatment measured by change in the Quick Inventory of Depressive Symptomatology (QIDS-C-16 item) (rated by an independent rater)
Timepoint [1] 237995 0
weeks 0 and 12
Primary outcome [2] 269280 0
Speed of early change measured by reduction in Quick Inventory of Depressive Symptomatology scores (QIDS-C-16 item) (rated by an independent rater)
Timepoint [2] 269280 0
weeks 0 and 4
Primary outcome [3] 269336 0
Early change measured by percent change in brain activation on fMRI in the dorso-lateral prefrontal cortex and amygdala regions
Timepoint [3] 269336 0
weeks 0 and 4
Secondary outcome [1] 279286 0
Time to achieve non-depressed status over the course of treatment measured by the Quick Inventory of Depressive Symptomatology- self report (QIDS- SR) (survival curve, QIDS-SR<6).
Timepoint [1] 279286 0
weekly self-report questionnaires for 12 weeks
Secondary outcome [2] 279287 0
Improvement in executive functioning, measured by the Rapid Visual Information Processing (CANTAB)
Timepoint [2] 279287 0
weeks 0, 4 and 12 weeks
Secondary outcome [3] 279288 0
Improved emotional processing, measured by the Recognition of posed facial expressions task
Timepoint [3] 279288 0
weeks 0, 4,and 12
Secondary outcome [4] 279289 0
Reduction in depressive rumination, measured by the Response Styles Questionnaire- rumination subscale
Timepoint [4] 279289 0
weeks 0, 4 and 12
Secondary outcome [5] 279290 0
Reduction in maladaptive metacognitions measured by the Metacognitions-30 scale
Timepoint [5] 279290 0
weeks 0, 4,and 12
Secondary outcome [6] 279406 0
Reduction in self-report depressive symptoms at end treatment rated by the Quick Inventory of Depressive Symptomatology- self report (QIDS- SR)
Timepoint [6] 279406 0
weeks 0, 4 and 12

Eligibility
Key inclusion criteria
Current major depressive disorder (DSM-IV)
Able to complete questionnaires and psychotherapy in the english language.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
On no psychoactive drugs (e.g. antidepressants, mood stabilisers, anxiolytics or antipsychotic drugs), moderate or severe alcohol or drug dependence as a primary diagnosis, bipolar I disorder or schizophrenia, major physical illness or head injury which could interfere with the fMRI procedure, neuropsychological assessment or psychotherapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed. The holder of the therapy allocation is outside the research team and holds the allocation in numbered sealed opaque envelopes, only releasing the envelope once the baseline assessments have been completed. Thus therapists recruiting and assessing participants are not given therapy allocation until the baseline assessment are complete, immediately prior to commencing therapy. The study co-ordinator will remain blind to therapy allocation throughout the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The pilot study was stopped due to funding ending and difficulty continuing the trial due to the disruption during 2011 caused by the Christchurch earthquakes.
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1801 0
New Zealand
State/province [1] 1801 0
Canterbury

Funding & Sponsors
Funding source category [1] 4995 0
Government body
Name [1] 4995 0
New Zealand Lottery Health Research grant
Address [1] 4995 0
Lottery Health Research
Department of Internal Affairs
46 Waring Taylor St
PO Box 805
WELLINGTON 6011
Country [1] 4995 0
New Zealand
Funding source category [2] 4996 0
University
Name [2] 4996 0
University of Otago Research Committee Grant
Address [2] 4996 0
Research & Enterprise Office
Centre for Innovation
University of Otago
Po Box 56 Cnr St David and Castle St
Dunedin, 9054
Country [2] 4996 0
New Zealand
Primary sponsor type
Individual
Name
Jennifer Jordan
Address
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 4517 0
University
Name [1] 4517 0
Research Office, University of Otago, Christchurch
Address [1] 4517 0
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country [1] 4517 0
New Zealand
Other collaborator category [1] 675 0
Individual
Name [1] 675 0
Professor Peter Joyce
Address [1] 675 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country [1] 675 0
New Zealand
Other collaborator category [2] 252123 0
Individual
Name [2] 252123 0
Dr Janet D Carter
Address [2] 252123 0
Psychology Department
University of Canterbury
Private Bag 4800
University Drive, Ilam
Christchurch 8041
Country [2] 252123 0
New Zealand
Other collaborator category [3] 252124 0
Individual
Name [3] 252124 0
Dr Virginia VW McIntosh
Address [3] 252124 0
Department of Psychological Medicine (& Canterbury District Health Board)
University of Otago, Christchurch
4 Oxford Terrace
Po Box 4345
Christchurch 8140
Country [3] 252124 0
New Zealand
Other collaborator category [4] 252125 0
Individual
Name [4] 252125 0
Professor Richard Porter
Address [4] 252125 0
Department of Psychological Medicine
University of Otago, Christchurch
4 Oxford Terrace
Po Box 4345
Christchurch 8140
Country [4] 252125 0
New Zealand
Other collaborator category [5] 252126 0
Individual
Name [5] 252126 0
Professor Roger Mulder
Address [5] 252126 0
Department of Psychological Medicine
University of Otago, Christchurch
4 Oxford Terrace
Po Box 4345
Christchurch 8140
Country [5] 252126 0
New Zealand
Other collaborator category [6] 252127 0
Individual
Name [6] 252127 0
Dr Kumari Fernando
Address [6] 252127 0
Department of Psychological Medicine
Dunedin School of Medicine
PO Box 913
University of Otago
Dunedin 9054
Country [6] 252127 0
New Zealand
Other collaborator category [7] 252162 0
Individual
Name [7] 252162 0
Associate Professor Christopher Frampton
Address [7] 252162 0
Department of Psychological Medicine
University of Otago, Christchurch
4 Oxford Terrace
Po Box 4345
Christchurch 8140
Country [7] 252162 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7098 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 7098 0
Ministry of Health
PO Box 3877
Christchurch 8013
Ethics committee country [1] 7098 0
New Zealand
Date submitted for ethics approval [1] 7098 0
Approval date [1] 7098 0
11/05/2009
Ethics approval number [1] 7098 0
URB/09/03/012

Summary
Brief summary
Depression is a common, often recurrent or chronic, serious health problem causing significant burden to individuals, their families and to society. The most evaluated psychotherapy, Cognitive Behaviour Therapy (CBT) is effective for around 50% of depressed individuals but relapse is common. Despite advances in knowledge about brain dysfunction and changes with recovery from depression, until recently there has been little integration of those findings with developments in the psychotherapy literature. Metacognitive Therapy (MCT) is a brief, innovative, targeted psychotherapy partly based on evidence of dysfunction in cognitive and emotional processing. We propose to treat 140 outpatients with depression in a randomised controlled trial of MCT vs. CBT. We hypothesise that MCT will act more rapidly and effectively in improving depression, with changes detectable on fMRI in a subset of participants. Being better able to understand how psychotherapies work in relation to brain function will contribute to development of better treatments.
Trial website
Trial related presentations / publications
Jordan J, Carter JD, McIntosh VV, Fernando K, Frampton CM, Porter RJ, et al. Metacognitive therapy versus cognitive behaviour therapy for depression: A randomised pilot study. Australian and New Zealand Journal of Psychiatry. 2014; 48(10):932–943.

Groves S, Porter R, Jordan J, Knight R, Carter J, McIntosh V, Fernando K, Frampton CM, Mulder RT, Lacey, Joyce PR. Changes in neuropsychological function after treatment with metacognitive therapy or cognitive behaviour therapy for depression. Depression and Anxiety. 2015; 36(6):437-44.
Public notes

Contacts
Principal investigator
Name 29633 0
Dr Jennifer Jordan
Address 29633 0
Department of Psychological Medicine University of Otago, Christchurch PO Box 4345 Christchurch 8140
Country 29633 0
New Zealand
Phone 29633 0
+64 3 3726700
Fax 29633 0
Email 29633 0
jenny.jordan@otago.ac.nz
Contact person for public queries
Name 12880 0
Dr Dr Jennifer Jordan
Address 12880 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 12880 0
New Zealand
Phone 12880 0
+64 3 3726700
Fax 12880 0
Email 12880 0
jenny.jordan@otago.ac.nz
Contact person for scientific queries
Name 3808 0
Dr Dr Jennifer Jordan
Address 3808 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 3808 0
New Zealand
Phone 3808 0
+64 3 3726700
Fax 3808 0
Email 3808 0
jenny.jordan@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary