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临床试验/NCT02790905
NCT02790905已完成不适用

Validating the Patient Health Questionnaire-9 (PHQ-9) and Refugee Health Screener-15(RHS-15) Questionnaires to Screen for Depression in Pregnant and Post-partum Migrant Women on the Thai-Myanmar Border

University of Oxford1 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
370
试验地点
1
主要终点
Validity of Patient Health Questionnaire-9 (PHQ-9)

研究概览

简要总结

The objective of this study is to validate the Patient Health Questionnaire-9 (PHQ-9) and the Refugee Health Screener-15 (RHS-15) screening tools for depression in pregnant and post-partum migrant women on the Thai-Myanmar border.

详细描述

Background: Mental illness affects a significant proportion of women during and after pregnancy. The most common form of mental illness is depression, which can manifest with symptoms such as sadness, loss of pleasure in activities, poor sleep, changes in appetite and, in severe cases, suicide. Depression during or after pregnancy can have profound effects on the mother, her family and wider society. Left untreated, depression can become chronic and recurrent and lead to reduced ability to work and provide care. Children of depressed mothers are at increased risk of poor growth, increased infections and delayed cognitive, behavioural and emotional development. Recognising maternal depression at an early stage and offering effective treatment such as counselling or anti-depressant medication is vital to helping women and minimising impacts on their families. To effectively diagnose depression, a variety of screening tools is available. However, psychometric properties vary across populations and contexts, and tools must be validated locally prior to use. This validation study will be based at the Shoklo Malaria Research Unit (SMRU), which has provided health services and conducted research in rural and disadvantaged populations living on the Thai-Myanmar border for nearly three decades.

Research design: The study will be an observational, cross-sectional validation study. Women will be asked to complete two questionnaires and an interview.

Study population: The study population will be women who are pregnant and post-partum (up to 12 months) attending SMRU antenatal and postnatal clinics at Wang Pha, Mawker Tai and Maela.

Method and technique (survey, interview, observation): The questionnaires will be translated into Burmese and Karen, and back-translated into English to ensure that semantics have been maintained. Pregnant and post-partum women attending antenatal clinics (ANC) and postnatal clinics (PNC) who volunteer to participate will be asked to provide consent. Participants will first be asked to complete two questionnaires: the PHQ-9 and RHS-15. These will be administered by a member of SMRU staff in Karen or Burmese. Participants will then be asked to attend a diagnostic interview conducted by the principal investigator with an interpreter. The principal investigator will be blinded to the results of the PHQ-9 and RHS-15 until completion of the interview.

Anticipated outcomes: The outcomes of this validation study will be measures of validity, reliability, sensitivity, specificity, positive predictive value and negative predictive value for each of the screening tools (PHQ-9 and RHS-15).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who are pregnant (at any stage of pregnancy) and post-partum (up to 12 months post-partum)
  • Willing and able to give informed consent for participation in the study
  • Aged 18 years or over

排除标准

  • Deemed by study staff to be acutely unwell and unable to participate
  • Known mental illness and undergoing treatment/therapy

结局指标

主要结局

Validity of Patient Health Questionnaire-9 (PHQ-9)

时间窗: at enrollment

Validity of Refugee Health Screener-15 (RHS-15) questionnaire

时间窗: at enrollment

次要结局

  • Specificity of Patient Health Questionnaire-9 (PHQ-9)(at enrollment)
  • Specificity of Refugee Health Screener-15 (RHS-15) questionnaire(at enrollment)
  • Sensitivity of Patient Health Questionnaire-9 (PHQ-9)(at enrollment)
  • Positive predictive value for each of Patient Health Questionnaire-9 (PHQ-9)(at enrollment)
  • Negative predictive value for each of Patient Health Questionnaire-9 (PHQ-9)(at enrollment)
  • Reliability of Patient Health Questionnaire-9 (PHQ-9)(at enrollment)
  • Reliability of Refugee Health Screener-15 (RHS-15) questionnaire(at enrollment)
  • Positive predictive value for each of Refugee Health Screener-15 (RHS-15) questionnaire(at enrollment)
  • Negative predictive value for each of Refugee Health Screener-15 (RHS-15) questionnaire(at enrollment)
  • Sensitivity of Refugee Health Screener-15 (RHS-15) questionnaire(at enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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