Trial Review

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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
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
Secondary ID [1] 262859 0
Nil
Universal Trial Number (UTN)
U1111-1123-7660
Trial acronym
Non-Melancholic Depression Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-melancholic depression 270574 0
Condition category
Condition code
Mental Health 270742 270742 0 0
Depression

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 269206 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 269440 0
Depression severity as measured by the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS)
Timepoint [1] 269440 0
Baseline, weekly from week 1 - week 10, follow-up (at 12 weeks)
Primary outcome [2] 269441 0
Depression Anxiety Stress Scale (DASS)
Timepoint [2] 269441 0
Baseline, weekly from week 1 - week 10, follow-up (at 12 weeks)
Primary outcome [3] 269442 0
Quality of Life Enjoyment and satisfaction Scale (Q-LES-Q)
Timepoint [3] 269442 0
Baseline, weekly from week 1 - week 10, follow-up (at 12 weeks)
Secondary outcome [1] 287651 0
Work Productivity and Activity Impairment Scale (WPAI)
Timepoint [1] 287651 0
Baseline, weekly from week 1 - week 10, follow-up (at 12 weeks)
Secondary outcome [2] 287652 0
Cromwell Crawley Questionnaire (Trait Anxiety)
Timepoint [2] 287652 0
Baseline and 12 week follow-up
Secondary outcome [3] 287653 0
Social Adjustment Scales - Self report (SAS-SR)
Timepoint [3] 287653 0
Baseline and 12 week follow-up
Secondary outcome [4] 287654 0
Psychologist and Psychiatrist Treatment Effectiveness Forms
Timepoint [4] 287654 0
Baseline and 12 week follow-up

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years old
Significant comorbidities present
Current drug and alcohol problems

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Recruiting
Date of first participant enrolment
Anticipated
17/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269678 0
Government body
Name [1] 269678 0
Department of Health and Aging
Country [1] 269678 0
Australia
Primary sponsor type
Government body
Name
Department of Health and Aging
Address
GPO Box 9848,
Canberra ACT 2601, Australia
Country
Australia
Secondary sponsor category [1] 268716 0
None
Name [1] 268716 0
Address [1] 268716 0
Country [1] 268716 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271631 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 271631 0
Ethics committee country [1] 271631 0
Australia
Date submitted for ethics approval [1] 271631 0
Approval date [1] 271631 0
06/10/2009
Ethics approval number [1] 271631 0
HREC 09251

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33032 0
Address 33032 0
Country 33032 0
Phone 33032 0
Fax 33032 0
Email 33032 0
Contact person for public queries
Name 16279 0
Rebecca Graham
Address 16279 0
Black Dog Institute, Hospital Rd
Prince of Wales Hospital
Randwick NSW 2031
Country 16279 0
Australia
Phone 16279 0
+61 2 93829253
Fax 16279 0
+61 2 9382 8510
Email 16279 0
[email protected]
Contact person for scientific queries
Name 7207 0
Gordon Parker
Address 7207 0
Black Dog Institute, Hospital Rd
Prince of Wales Hospital
Randwick NSW 2031
Country 7207 0
Australia
Phone 7207 0
+61 2 93824372
Fax 7207 0
+61 2 93824343
Email 7207 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
SourceTitleYear of PublicationDOI
Dimensions AIThe Treatment of Nonmelancholic Depression: When Antidepressants Fail, Does Psychotherapy Work?2014https://doi.org/10.1177/070674371405900703
N.B. These documents automatically identified may not have been verified by the study sponsor.