Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-27 @ 4:41 AM
Study NCT ID:
NCT02790905
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2016-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validating the Patient Health Questionnaire in Pregnant and Post-partum Migrant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-05', 'studyFirstSubmitDate': '2016-05-19', 'studyFirstSubmitQcDate': '2016-06-02', 'lastUpdatePostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'at enrollment'}, {'measure': 'Validity of Refugee Health Screener-15 (RHS-15) questionnaire', 'timeFrame': 'at enrollment'}], 'secondaryOutcomes': [{'measure': 'Reliability of Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'at enrollment'}, {'measure': 'Reliability of Refugee Health Screener-15 (RHS-15) questionnaire', 'timeFrame': 'at enrollment'}, {'measure': 'Sensitivity of Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'at enrollment'}, {'measure': 'Sensitivity of Refugee Health Screener-15 (RHS-15) questionnaire', 'timeFrame': 'at enrollment'}, {'measure': 'Specificity of Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'at enrollment'}, {'measure': 'Specificity of Refugee Health Screener-15 (RHS-15) questionnaire', 'timeFrame': 'at enrollment'}, {'measure': 'Positive predictive value for each of Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'at enrollment'}, {'measure': 'Positive predictive value for each of Refugee Health Screener-15 (RHS-15) questionnaire', 'timeFrame': 'at enrollment'}, {'measure': 'Negative predictive value for each of Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'at enrollment'}, {'measure': 'Negative predictive value for each of Refugee Health Screener-15 (RHS-15) questionnaire', 'timeFrame': 'at enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pregnant and post-partum women', 'Validation questionnaires', 'Thai-Myanmar border'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '29306876', 'type': 'DERIVED', 'citation': 'Fellmeth G, Plugge EH, Carrara V, Fazel M, Oo MM, Phichitphadungtham Y, Pimanpanarak M, Wai NK, Mu O, Charunwatthana P, Nosten F, Fitzpatrick R, Mcgready R. Migrant perinatal depression study: a prospective cohort study of perinatal depression on the Thai-Myanmar border. BMJ Open. 2018 Jan 5;8(1):e017129. doi: 10.1136/bmjopen-2017-017129.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nResearch design: The study will be an observational, cross-sectional validation study. Women will be asked to complete two questionnaires and an interview.\n\nStudy 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.\n\nMethod 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.\n\nAnticipated 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).\n\nPotential 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who are pregnant (at any stage of pregnancy) and post-partum up to 12 months post-partum, aged 18 years or over, who are willing and able to participate.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who are pregnant (at any stage of pregnancy) and post-partum (up to 12 months post-partum)\n* Willing and able to give informed consent for participation in the study\n* Aged 18 years or over\n\nExclusion Criteria:\n\n* Deemed by study staff to be acutely unwell and unable to participate\n* Known mental illness and undergoing treatment/therapy'}, 'identificationModule': {'nctId': 'NCT02790905', 'briefTitle': 'Validating the Patient Health Questionnaire in Pregnant and Post-partum Migrant Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SMRU1503'}}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'Mae Sot', 'state': 'Changwat Tak', 'country': 'Thailand', 'facility': 'Shoklo Malaria Research Unit', 'geoPoint': {'lat': 16.71667, 'lon': 98.56667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}