Depression Clinical Trial
Official title:
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
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.
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).
Potential value and significance: If the questionnaires are found to be valid in the local
population they can be used as a routine screen for depression for all women attending
antenatal and postnatal clinics at SMRU. Helping to identify women with depression will
enable earlier treatment and minimise the impact of depression on her and her family.
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