None listed
Conditions
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.
Interventions
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.
Sponsors
Dr Felicity Goodyear-Smith
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed