ACTRN12606000483550尚未招募1 期
Randomised controlled trial of a New Zealand developed screening questionnaire for depression compared with a gold standard
Dr Felicity Goodyear-Smith0 个研究点目标入组 5,500 人开始时间: 2006年11月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Diagnosis
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •On current psychotrophic medication, cannot read English, intoxicated, dementia and terminal illness.
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