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Trial registered on ANZCTR
Registration number
ACTRN12611000932965
Ethics application status
Approved
Date submitted
30/08/2011
Date registered
30/08/2011
Date last updated
30/08/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Non melancholic depression: a naturalistic treatment outcome study
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Scientific title
The effect of in-house psychological treatment at the Black Dog Institute Depression Clinic on severity of symptoms in participants with non-melancholic depression who have tried two or more antidepressants
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Secondary ID [1]
262859
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Nil
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Universal Trial Number (UTN)
U1111-1123-7660
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Trial acronym
Non-Melancholic Depression Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-melancholic depression
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Condition category
Condition code
Mental Health
270742
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
All treatment in this trial forms part of routine clinical management. Patients in the "treatment" group receive ten 50 minute sessions with a Black Dog Institute Clinical Psychologist over a 12 week period. The first 8 sessions are weekly, and the last two sessions are fortnightly.There is no uniform psychological treatment used for all patients - rather, treatment type is tailored to the patients particular concerns (as it would be in the "real" world).
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Intervention code [1]
269206
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Treatment: Other
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Comparator / control treatment
An "external" group - comprised of those patients who (for whatever reason) are not able to attend the Black Dog Institute for twelve weeks of treatment - are also assessed over the twelve week period. Patients in this group will be compared with those in the treatment group but will fall into roughly twp categories: those who receive (external) psychological intervention, and those who do not.
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Control group
Active
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Outcomes
Primary outcome [1]
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Depression severity as measured by the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS)
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Assessment method [1]
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Timepoint [1]
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Baseline, weekly from week 1 - week 10, follow-up (at 12 weeks)
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Primary outcome [2]
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Depression Anxiety Stress Scale (DASS)
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Assessment method [2]
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Timepoint [2]
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Baseline, weekly from week 1 - week 10, follow-up (at 12 weeks)
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Primary outcome [3]
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Quality of Life Enjoyment and satisfaction Scale (Q-LES-Q)
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Assessment method [3]
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Timepoint [3]
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Baseline, weekly from week 1 - week 10, follow-up (at 12 weeks)
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Secondary outcome [1]
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Work Productivity and Activity Impairment Scale (WPAI)
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Assessment method [1]
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Timepoint [1]
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Baseline, weekly from week 1 - week 10, follow-up (at 12 weeks)
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Secondary outcome [2]
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Cromwell Crawley Questionnaire (Trait Anxiety)
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Assessment method [2]
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Timepoint [2]
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Baseline and 12 week follow-up
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Secondary outcome [3]
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Social Adjustment Scales - Self report (SAS-SR)
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Assessment method [3]
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Timepoint [3]
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Baseline and 12 week follow-up
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Secondary outcome [4]
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Psychologist and Psychiatrist Treatment Effectiveness Forms
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Assessment method [4]
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Timepoint [4]
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Baseline and 12 week follow-up
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Eligibility
Key inclusion criteria
Diagnosis by BDI Psychiatrist of non-melancholic depression
Over 18 years old
Tried two or more antidepressants - at least one must have been a trial of more than 4 weeks with cessation not entirely due to side effects
Not have received psychological therapy within the last 3 months
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Under 18 years old
Significant comorbidities present
Current drug and alcohol problems
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
If a patient meets the eligibility criteria for the study, the group (treatment versus external) that they enter is entirely dependent on whether they can attend ten weekly sessions at the BDI (in Randwick). If this is not possible - they are automatically assigned to the external group. Allocation to groups is not concealed to participants.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
17/08/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Department of Health and Aging
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Address [1]
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GPO Box 9848,
Canberra ACT 2601, Australia
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Country [1]
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Australia
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Primary sponsor type
Government body
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Name
Department of Health and Aging
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Address
GPO Box 9848,
Canberra ACT 2601, Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
268716
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of New South Wales Human Research Ethics Committee
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Ethics committee address [1]
271631
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
271631
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Approval date [1]
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06/10/2009
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Ethics approval number [1]
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HREC 09251
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Summary
Brief summary
The current research aims to determine whether changing the treatment paradigm from a drug to a non-drug (i.e psychological) approach will result in improved outcomes for those with a unipolar non-melancholic depression. By altering the primary treatment approach, we hypothesise that more positive outcomes are likely to occur.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Rebecca Graham
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Address
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Black Dog Institute, Hospital Rd
Prince of Wales Hospital
Randwick NSW 2031
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Country
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Australia
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Phone
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+61 2 93829253
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Fax
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+61 2 9382 8510
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Email
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[email protected]
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Contact person for scientific queries
Name
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Gordon Parker
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Address
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Black Dog Institute, Hospital Rd
Prince of Wales Hospital
Randwick NSW 2031
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Country
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Australia
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Phone
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+61 2 93824372
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Fax
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+61 2 93824343
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Dimensions AI
The Treatment of Nonmelancholic Depression: When Antidepressants Fail, Does Psychotherapy Work?
2014
https://doi.org/10.1177/070674371405900703
N.B. These documents automatically identified may not have been verified by the study sponsor.
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