An interventional study of psychiatric interview in Post Partum Depression, sponsored by Fondation Hôpital Saint-Joseph. Not yet recruiting at 3 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Fondation Hôpital Saint-Joseph · Not applicable, Interventional, and Prevention
Postpartum depression (affecting approximately 15% of women) and childbirth-related post-traumatic stress disorder (PTSD) (affecting approximately 5%) are major public health concerns due to their frequency and their impact on both maternal and child health. Diagnosis relies on specialized clinical interviews, which are difficult to offer systematically to all women after childbirth. Consequently, self-report screening tools are widely used, particularly the Edinburgh Postnatal Depression Scale (EPDS) for postpartum depression and the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) for PTSD.
However, these tools were developed and validated in the general population and may be less suitable for certain groups, particularly migrant women, who are at increased risk of postpartum mental health disorders. Their migration experiences are sometimes marked by traumatic events, which may contribute to complex forms of PTSD, and their clinical presentations may differ from those typically observed. Certain culturally specific expressions of psychological distress, dissociative symptoms, or somatic manifestations are not captured by current screening questionnaires.
Furthermore, cultural differences, perceptions of mental health, and language barriers may complicate the psychological assessment of these women and influence their responses to screening tools. These specific factors suggest that existing questionnaires may have insufficient diagnostic performance in some groups of migrant women.
The Psy4Mums project therefore aims to assess the relevance and performance of these screening tools in migrant populations that are particularly vulnerable from psychological, social, and economic perspectives. This evaluation may, if necessary, lead to adaptations in their content, cutoff scores, or methods of administration in order to improve the identification of postpartum mental health disorders. This approach is especially important in French Guiana, where more than half of all women giving birth are migrants.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 80 is below the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 346 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Other: psychiatric interview
At 6 to 10 weeks postpartum, the patient attends an interview with a psychiatrist specialized in perinatal psychiatry. During this consultation, the patient completes the Edinburgh Postnatal Depression Scale (EPDS) and the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) questionnaires. The physician then assesses the patient's level of difficulty in completing these questionnaires. This is followed by a standard 45-minute psychiatric clinical assessment focusing on the patient's experience of pregnancy.
Comparison of PC-PTSD Score with psychiatric evaluation of PTSD
Proportion of women with PTSD identified during the psychiatric interview (gold standard) but with a PC-PTSD-5 score \< 4, below the conventionally used screening cutoff (false-negative result of the scale), estimated separately in each of the two groups
Time frame: from enrollement to 10 week post partum
Comparison of EPDS Score with psychiatric evalution of post partum depression
Proportion of women with postpartum depression identified during the psychiatric interview (gold standard) but with an EPDS score \< 11, i.e., below the screening cutoff conventionally used in current clinical practice (false-negative result of the scale), estimated separately among migrant women in the Paris region (Île-de-France) and French Guiana, and among women native to French Guiana.
Time frame: from enrollement to 10 week post partum
Description of post partum depression symptoms and PTSD symptoms
Nature and significance of the symptoms identified during the psychiatric interview that are not covered by the items included in the two screening scales (qualitative component of the primary outcome).
Time frame: from enrollement to 10 weeks post partum
Evaluation ofthe performance of the EPDS and PC-PTSD-5 as screening tools for postpartum depression (PPD) and post-traumatic stress disorder (PTSD) among groups of migrant women in the Paris region (Île-de-France) and French Guiana, as well as a group of
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve (AUC) for different EPDS (PPD) and PC-PTSD-5 (PTSD) cutoff scores, estimated separately in each group (migrant women; native women from French Guiana), and subsequently according to the level of obstetric risk (exploratory analyses).
Time frame: from enrollement to 10 weeks post partum
Proportion of false-positive generated by the EPDS and PC-PTSD-5 screening scales, compared to the psychiatric interview
Proportion of false-positive results on the EPDS (score ≥ 11 without confirmed PPD) and the PC-PTSD-5 (score ≥ 4 without confirmed PTSD) based on the psychiatric interview among migrant women in the Paris region and French Guiana, and among a group of non-migrant women in French Guiana
Time frame: from enrollement to 10 weeks post partum
To assess women's perceptions of completing these self-administered questionnaires, particularly regarding the cultural relevance of the items and the mode of administration.
Qualitative characterization of false-positive cases based on findings from the interviews.
Time frame: from enrollement to 10 weeks post partum
Identification of potential adaptations of the EPDS and PC-PTSD-5
Women's perceptions of completing the questionnaires and their suggestions for adaptation (qualitative analysis), including modifications of cutoff scores, the addition of questions, and adaptations to the content
Time frame: from enrollement to 10 weeks post partum
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Sep 2027, 9 months later.
Of 256 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 9 months is below that.
Counting every sponsor, half of 262 studies reached it within 23 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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