Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000483550
Ethics application status
Approved
Date submitted
20/11/2006
Date registered
23/11/2006
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of a New Zealand developed screening questionnaire for depression compared with a gold standard
Scientific title
Randomised controlled trial of a New Zealand developed screening questionnaire for depression compared with a gold standard
Secondary ID [1] 318 0
RCT of TQWHQ and PHQ depression screening tools compared with CIDI gold standard
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 1460 0
Condition category
Condition code
Mental Health 1556 1556 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
New Zealand developed screening tool TQWHQ (Two questions with help question)compared with PHQ-9 (Patient Health Questionnaire for depression) and with control

All three arms involve questionnaires seeking the same demographic data. In the PHQ and TQWHQ arms this is followed by the appropriate screening tool.
The time point of assessment is the same day. Comparisons between screening tool and gold standard are made at the day of data collection
The duration of the study is two years.
Intervention code [1] 1454 0
Early detection / Screening
Comparator / control treatment
The control arm receives usual care. This means that they get their standard treatment from their GP and the GP does not have any screening prompt regarding possible depression.
Control group
Active

Outcomes
Primary outcome [1] 2149 0
GP diagnosis of major depression using the GP Assessment & Intervention Record (GAIR)

All patients complete one of the three screening arms (TQWHQ, PHQ or control), the drug sheet and the CIDI gold standard immediately before their GP consultation.
Timepoint [1] 2149 0
The assessment is made on the same day as the screening with the GP completing GAIR at the end of the consultation.
Primary outcome [2] 2150 0
Sensitivity & specificity of TQWHQ & PHQ.

All patients complete one of the three screening arms (TQWHQ, PHQ or control), the drug sheet and the CIDI gold standard immediately before their GP consultation.
Timepoint [2] 2150 0
The assessment is made on the same day as the screening with the GP completing GAIR at the end of the consultation.
Secondary outcome [1] 3730 0
Treatment offered
Timepoint [1] 3730 0
Secondary outcome [2] 3731 0
Cases of depression detected by each screening instrument in comparison to that ascertained by the gold standard
Timepoint [2] 3731 0
Secondary outcome [3] 3732 0
GP preference for the respective questionnaires
Timepoint [3] 3732 0
Secondary outcome [4] 3733 0
All patients complete one of the three screening arms (TQWHQ, PHQ or control), the drug sheet and the CIDI gold standard immediately before their GP consultation. The GP completes the GAIR at the end of the consultation.
Timepoint [4] 3733 0

Eligibility
Key inclusion criteria
Sample size based on a difference of 20% (60% to 80%) and a point prevalence of 5% will require 5500 (1833 in each group) patients (excluding about 10% on medication) (two sided alpha =0.05 beta = 0.2). Analysis stratified on GPs (with GPs as a random effect) using a generalised linear mixed model. A sample size based on a difference of 17% detected cases of major depression (77% to 60%) would require 180 patients. The 60% is the sensitivity of the PHQ and the 77% a conservative estimate of the TQWHQ. Thus 36 GPs are needed with 150 patients per GP. Inclusion: Eligible patients include all those able to communicate in English who are not suffering from any brain injury, terminal illness or intoxication. Patients with possible dementia will be included unless they demonstrate an inability to comprehend and answer the questions. Patients will be consecutive as this is the best means of obtaining an adequate spectrum of disease which is important in screening and diagnostic test studies.18 We will attempt to recruit approximately 50% of the study from Maori patients which may require over-sampling in some suburbs.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
On current psychotrophic medication, cannot read English, intoxicated, dementia and terminal illness.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random order computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The assessor is blinded to the intervention
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5500
Accrual to date
Final
Recruitment outside Australia
Country [1] 421 0
New Zealand
State/province [1] 421 0

Funding & Sponsors
Funding source category [1] 1697 0
Government body
Name [1] 1697 0
Health Research Council of New Zealand
Country [1] 1697 0
New Zealand
Primary sponsor type
Individual
Name
Dr Felicity Goodyear-Smith
Address
Country
Secondary sponsor category [1] 1497 0
Individual
Name [1] 1497 0
Prof Bruce Arroll
Address [1] 1497 0
Country [1] 1497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3148 0
Northern Y Regional Ethics Committee New Zealand-University of Auckland
Ethics committee address [1] 3148 0
Ethics committee country [1] 3148 0
New Zealand
Date submitted for ethics approval [1] 3148 0
Approval date [1] 3148 0
20/10/2006
Ethics approval number [1] 3148 0
NTY/06/09/080
Ethics committee name [2] 3149 0
Northern Y Regional Ethics Committee New Zealand-the greater Auckland region
Ethics committee address [2] 3149 0
Ethics committee country [2] 3149 0
New Zealand
Date submitted for ethics approval [2] 3149 0
Approval date [2] 3149 0
20/10/2006
Ethics approval number [2] 3149 0
NTY/06/09/080

Summary
Brief summary
Depression is second only to stroke as the leading cause of years of life lost to disability. It is common in general practice and Maori patients have high rates of depression. Without screening GPs sometimes have difficulty in detecting patients with depression. Screening for depression has been shown to both increase the diagnosis and benefit from treatment. The recommended screening tool is one from the USA called the PHQ (Primary Health questionnaire). We have developed a shorter questionnaire that may be better at detecting depression and in addition directs the health provider to give help appropriately. We have named it the Two questions with Help Question (TQWHQ). We wish to compare our TQWHQ with the PHQ and no screening in a primary care-based clinical trial to prove that our tool is better at detecting depression and improves GP diagnosis. Effective treatments are available but of no value unless a diagnosis is made.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27388 0
Address 27388 0
Country 27388 0
Phone 27388 0
Fax 27388 0
Email 27388 0
Contact person for public queries
Name 10643 0
Felicity Goodyear-Smith
Address 10643 0
Department of General Practice & Primary Health Care
University of Auckland
PB 92019
Auckland
Country 10643 0
New Zealand
Phone 10643 0
+64 93737599 82357
Fax 10643 0
+64 93737624
Email 10643 0
f.goodyear-smith@auckland.ac.nz
Contact person for scientific queries
Name 1571 0
Felicity Goodyear-Smith
Address 1571 0
Department of General Practice & Primary Health Care
University of Auckland
PB 92019
Auckland
Country 1571 0
New Zealand
Phone 1571 0
+64 93737599 82357
Fax 1571 0
+64 93737624
Email 1571 0
f.goodyear-smith@auckland.ac.nz

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
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