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Completed

NCT Number: NCT02790905

Validating the Patient Health Questionnaire in Pregnant and Post-partum Migrant Women

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: at enrollment

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

    Time frame: at enrollment

Secondary outcomes

  1. Reliability of Patient Health Questionnaire-9 (PHQ-9)

    Time frame: at enrollment

  2. Reliability of Refugee Health Screener-15 (RHS-15) questionnaire

    Time frame: at enrollment

  3. Sensitivity of Patient Health Questionnaire-9 (PHQ-9)

    Time frame: at enrollment

  4. Sensitivity of Refugee Health Screener-15 (RHS-15) questionnaire

    Time frame: at enrollment

  5. Specificity of Patient Health Questionnaire-9 (PHQ-9)

    Time frame: at enrollment

  6. Specificity of Refugee Health Screener-15 (RHS-15) questionnaire

    Time frame: at enrollment

  7. Positive predictive value for each of Patient Health Questionnaire-9 (PHQ-9)

    Time frame: at enrollment

  8. Positive predictive value for each of Refugee Health Screener-15 (RHS-15) questionnaire

    Time frame: at enrollment

  9. Negative predictive value for each of Patient Health Questionnaire-9 (PHQ-9)

    Time frame: at enrollment

  10. Negative predictive value for each of Refugee Health Screener-15 (RHS-15) questionnaire

    Time frame: at enrollment

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2016
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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