DepressionNCT02790905
Validating the Patient Health Questionnaire in Pregnant and Post-partum Migrant Women
An observational study of Depression, run by University of Oxford at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 370 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2015to 30 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Deemed by study staff to be acutely unwell and unable to participate
- Known mental illness and undergoing treatment/therapy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Depression
- Keywords
- pregnant and post-partum women, Validation questionnaires, Thai-Myanmar border
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of Patient Health Questionnaire-9 (PHQ-9)
Measured: at enrollment
Validity of Refugee Health Screener-15 (RHS-15) questionnaire
Measured: at enrollment
Secondary outcomes (10)
Reliability of Patient Health Questionnaire-9 (PHQ-9)
Measured: at enrollment
Reliability of Refugee Health Screener-15 (RHS-15) questionnaire
Measured: at enrollment
Sensitivity of Patient Health Questionnaire-9 (PHQ-9)
Measured: at enrollment
Sensitivity of Refugee Health Screener-15 (RHS-15) questionnaire
Measured: at enrollment
Specificity of Patient Health Questionnaire-9 (PHQ-9)
Measured: at enrollment
Specificity of Refugee Health Screener-15 (RHS-15) questionnaire
Measured: at enrollment
Positive predictive value for each of Patient Health Questionnaire-9 (PHQ-9)
Measured: at enrollment
Positive predictive value for each of Refugee Health Screener-15 (RHS-15) questionnaire
Measured: at enrollment
Negative predictive value for each of Patient Health Questionnaire-9 (PHQ-9)
Measured: at enrollment
Negative predictive value for each of Refugee Health Screener-15 (RHS-15) questionnaire
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startSep 2015
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790905
- Sponsor's protocol ID
- SMRU1503
- Status last verified
- Oct 2017
- First submitted
- 19 May 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 29306876
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02790905
- Acronym / sponsor ID
- SMRU1503
- Conditions
- Depression
- Keywords
- pregnant and post-partum women, Validation questionnaires, Thai-Myanmar border
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Deemed by study staff to be acutely unwell and unable to participate
- Known mental illness and undergoing treatment/therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validity of Patient Health Questionnaire-9 (PHQ-9)
Time frame: at enrollment
Validity of Refugee Health Screener-15 (RHS-15) questionnaire
Time frame: at enrollment
10 secondary outcomes
Reliability of Patient Health Questionnaire-9 (PHQ-9)
Time frame: at enrollment
Reliability of Refugee Health Screener-15 (RHS-15) questionnaire
Time frame: at enrollment
Sensitivity of Patient Health Questionnaire-9 (PHQ-9)
Time frame: at enrollment
Sensitivity of Refugee Health Screener-15 (RHS-15) questionnaire
Time frame: at enrollment
Specificity of Patient Health Questionnaire-9 (PHQ-9)
Time frame: at enrollment
Specificity of Refugee Health Screener-15 (RHS-15) questionnaire
Time frame: at enrollment
Positive predictive value for each of Patient Health Questionnaire-9 (PHQ-9)
Time frame: at enrollment
Positive predictive value for each of Refugee Health Screener-15 (RHS-15) questionnaire
Time frame: at enrollment
Negative predictive value for each of Patient Health Questionnaire-9 (PHQ-9)
Time frame: at enrollment
Negative predictive value for each of Refugee Health Screener-15 (RHS-15) questionnaire
Time frame: at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Derived from this study: PubMed 29306876Fellmeth 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of Patient Health Questionnaire-9 (PHQ-9) (time frame: at enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02790905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.