Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000705684
Ethics application status
Approved
Date submitted
17/06/2014
Date registered
3/07/2014
Date last updated
2/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Is the culturally adapted 9-item Patient Health Questionnaire (aPHQ-9) suitable for use as a screening tool to identify depression in Aboriginal and Torres Strait Islander people attending primary care?
Scientific title
Is the culturally adapted 9-item Patient Health Questionnaire (aPHQ-9) suitable for use as a screening tool to identify depression in Aboriginal and Torres Strait Islander people attending primary care?
Secondary ID [1] 284767 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Getting it right: the validation study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 292139 0
Condition category
Condition code
Mental Health 292474 292474 0 0
Depression
Public Health 292639 292639 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Five Aboriginal language groups of Central Australian Aboriginal men independently selected the 9-item Patient Health Questionnaire (PHQ-9) depression screening tool from a selection of depression screening tools, as the most appropriate to adapt for use with Indigenous people. The PHQ-9 was adapted to the local needs of all five language groups over 12-months and consensus regarding wording was reached. The PHQ-9 wording was modified, using simplified English, to make the ‘adapted PHQ-9’ (aPHQ-9) culturally meaningful and give it face validity. In qualitative interviews with the same participants, seven critical domains of depressive experience within Indigenous men were identified that were not covered in existing depression case-finding measures: anger, weakened spirit, homesickness, irritability, excessive worry, rumination, and drug/alcohol use.
Following consent participants will complete two separate interviews up to one week apart.
Interview 1: the adapted PHQ-9 and additional 7 questions will be administered (face to face) by a trained member of the primary health care service’s staff followed by demographic questions. (Up to 20 minutes)
Interview 2: MINI International Neuropsychiatric Interview 6.0.0. will be administered (face to face) by a trained member of the primary health care service’s staff or by a centralised interviewer (over the telephone) (Up to 20 minutes)
Intervention code [1] 289562 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292340 0
The clinicial diagnosis of depression according to the MINI 6.0.0, having two categories: "major depressive episode" and "no major depressive episode".
Timepoint [1] 292340 0
Baseline
Secondary outcome [1] 308733 0
Participant's acceptability of different aspects of the aPHQ-9.
Timepoint [1] 308733 0
This will be measured in 5-points Likert scales within one week of aPHQ-9 interview.
Secondary outcome [2] 309038 0
Feasibility of assessment within PHCS services. Should the aPHQ-9 (with or without the addition of one or more of the seven additional questions) have acceptable sensitivity and specificity as a screening tool for depression we will seek qualitative feedback on feasibility from PHCS staff during the feedback of study results to sites.
Timepoint [2] 309038 0
Semi-structured interviews will be used to assess this outcome. Site staff will be asked about the burden screening placed on them, their participants and the practice, the effect on the participant/clinician relationship, the usefulness of the aPHQ-9 and the extent to which practice routines must be adapted to integrate the aPHQ-9 into their service delivery.
This will be completed within 6 months of finishing study recruitment.

Eligibility
Key inclusion criteria
Aged 18 years
Self identifies as Aboriginal or Torres Strait Islander
Attending a primary health care service in Australia
Able to communicate sufficiently to complete study instruments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known psychosis
Known bipolar disorder

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We computed the sample size based on the target precision for the estimation of sensitivity and specificity of the aPHQ-9 used for the screening of a major depressive episode (MDE). Assuming a MDE prevalence (assessed by the MINI 6.0.0) of 10% and a true sensitivity of 0.85, a sample size of 500 participants will give us a precision of 0.1 for the sensitivity’s 95% confidence interval. For the specificity, 500 participants will provide a precision of 0.04 for the specificity’s 95% confidence interval, assuming a true specificity of 0.75 and the same prevalence of 10%. If the prevalence of MDE is in fact higher, for example 15%, the precision for the sensitivity will be 0.08.
For the analysis of the contribution of additional questions to the aPHQ-9, a sample size of 500 will give us 80% probability (power) of detecting a true improvement of 0.05 in the area under the ROC curve, fixing the type I error at 0.05.
For descriptive purposes baseline characteristics will be presented. Discrete variables will be summarised by frequencies and percentages, continuous variables by use of standard measures of central tendency and dispersion, mean and standard deviation (SD) or median and interquartile range (IQR).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2014
Actual
25/03/2015
Date of last participant enrolment
Anticipated
1/09/2016
Actual
4/11/2016
Date of last data collection
Anticipated
23/12/2016
Actual
16/11/2016
Sample size
Target
500
Accrual to date
Final
500
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 289384 0
Government body
Name [1] 289384 0
National Health and Medical Research Council (NHMRC), Australia
Country [1] 289384 0
Australia
Primary sponsor type
Individual
Name
A/Prof Maree Hackett
Address
The George Institute
PO Box M201 Missenden Rd
Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 288071 0
None
Name [1] 288071 0
Address [1] 288071 0
Country [1] 288071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291148 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 291148 0
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006
Ethics committee country [1] 291148 0
Australia
Date submitted for ethics approval [1] 291148 0
21/04/2014
Approval date [1] 291148 0
19/05/2014
Ethics approval number [1] 291148 0
2014/361
Ethics committee name [2] 292837 0
Aboriginal Health and Medical Research Council in NSW
Ethics committee address [2] 292837 0
PO Box 1565
STRAWBERRY HILLS
NSW 2012
Ethics committee country [2] 292837 0
Australia
Date submitted for ethics approval [2] 292837 0
Approval date [2] 292837 0
28/01/2015
Ethics approval number [2] 292837 0
EC00342
Ethics committee name [3] 292838 0
ACT Health Human Research Ethics Committee
Ethics committee address [3] 292838 0
Building 10 level 6
Canberra Hospital
PO Box 11 WODEN ACT 2606
Ethics committee country [3] 292838 0
Australia
Date submitted for ethics approval [3] 292838 0
Approval date [3] 292838 0
22/09/2014
Ethics approval number [3] 292838 0
EC00100
Ethics committee name [4] 292839 0
Metro South Human Research Ethics Committee
Ethics committee address [4] 292839 0
Princess Alexandra Hospital
Level 7 Translational Research Institute
37 Kent Street
WOOLLOONGABBA QLD 4102
Ethics committee country [4] 292839 0
Australia
Date submitted for ethics approval [4] 292839 0
Approval date [4] 292839 0
16/10/2014
Ethics approval number [4] 292839 0
EC00167
Ethics committee name [5] 292840 0
Central Australian Human Research Ethics Committee
Ethics committee address [5] 292840 0
Central Australian Human Research Ethics Committee
PO Box 4066
ALICE SPRINGS NT 0871
Ethics committee country [5] 292840 0
Australia
Date submitted for ethics approval [5] 292840 0
Approval date [5] 292840 0
18/03/2015
Ethics approval number [5] 292840 0
EC00155
Ethics committee name [6] 292841 0
Human Research Ethics Committee for the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [6] 292841 0
PO Box 41096
CASUARINA NT 0810
Ethics committee country [6] 292841 0
Australia
Date submitted for ethics approval [6] 292841 0
Approval date [6] 292841 0
23/02/2015
Ethics approval number [6] 292841 0
EC00153
Ethics committee name [7] 293771 0
Aboriginal Health Council of South Australia - Aboriginal Health Research Ethics Committee
Ethics committee address [7] 293771 0
PO Box 981
UNLEY, SA 5061
Ethics committee country [7] 293771 0
Australia
Date submitted for ethics approval [7] 293771 0
07/07/2015
Approval date [7] 293771 0
07/07/2015
Ethics approval number [7] 293771 0
04-15-622
Ethics committee name [8] 294044 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [8] 294044 0
450 Beaufort St,
Highgate WA 6003
Ethics committee country [8] 294044 0
Australia
Date submitted for ethics approval [8] 294044 0
01/10/2015
Approval date [8] 294044 0
24/11/2015
Ethics approval number [8] 294044 0
670

Summary
Brief summary
This cross sectional project will involve 500 Indigenous primary care attendees in Australia’s States and Territories. We will validate (criterion validity) the aPHQ-9 as a screening tool, alone, and in combination with the additional seven questions, against a gold standard structured criterion interview for depression The Mini International Neuropsychiatric Interview (MINI ) 6.0.0 (criterion standard), in Indigenous men and women attending primary health care services across Australia.
This will provide the evidence on whether to recommend use of the aPHQ-9 as a screening tool for depression in health services research, clinical care delivery and policy evaluation in Federal and State chronic diseases programmes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49098 0
A/Prof Maree Hackett
Address 49098 0
The George Institute
PO BOX M201 Missenden Rd
Camperdown NSW 2050
Country 49098 0
Australia
Phone 49098 0
+61 2 8052 4502
Fax 49098 0
+61 2 9993 4502
Email 49098 0
[email protected]
Contact person for public queries
Name 49099 0
Ms Sara Farnbach
Address 49099 0
The George Institute
PO BOX M201 Missenden Rd
Camperdown NSW 2050
Country 49099 0
Australia
Phone 49099 0
+61 2 9993 4571
Fax 49099 0
+61 2 8052 4571
Email 49099 0
[email protected]
Contact person for scientific queries
Name 49100 0
A/Prof Maree Hackett
Address 49100 0
The George Institute
PO BOX M201 Missenden Rd
Camperdown NSW 2050
Country 49100 0
Australia
Phone 49100 0
+61 2 8052 4502
Fax 49100 0
+61 2 9993 4502
Email 49100 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
EmbaseGetting it Right: Study protocol to determine the diagnostic accuracy of a culturally-specific measure to screen for depression in Aboriginal and/or Torres Strait Islander people.2016https://dx.doi.org/10.1136/bmjopen-2016-015009
N.B. These documents automatically identified may not have been verified by the study sponsor.