Randomised controlled trial of a New Zealand developed screening questionnaire for depression compared with a gold standard

Phase 1

• Conditions: Depression; Mental Health - Depression

• Registration Number: ACTRN12606000483550
• Lead Sponsor: Dr Felicity Goodyear-Smith

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 5500

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.

Exclusion Criteria

On current psychotrophic medication, cannot read English, intoxicated, dementia and terminal illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GP diagnosis of major depression using the GP Assessment & Intervention Record (GAIR)<br><br>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 assessment is made on the same day as the screening with the GP completing GAIR at the end of the consultation.];Sensitivity & specificity of TQWHQ & PHQ. <br><br>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 assessment is made on the same day as the screening with the GP completing GAIR at the end of the consultation.]

Secondary Outcome Measures

Name	Time	Method
Treatment offered[];Cases of depression detected by each screening instrument in comparison to that ascertained by the gold standard [];GP preference for the respective questionnaires[];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.[]