An observational study in Depression Disorder and Post Traumatic Stress Disorder PTSD, sponsored by Centre Hospitalier Universitaire de Besancon. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Centre Hospitalier Universitaire de Besancon · Observational
In France, perinatal mental health has become a major public health issue. Maternal mental health conditions can have serious consequences, including death by suicide. Fathers may also experience significant psychological distress during the perinatal period. These difficulties can affect parents' well-being, the developing parent-infant relationship, and family life, highlighting the importance of early identification and appropriate support for both parents.
The birth of an infant before 28 completed weeks of gestation can be a traumatic experience for parents. Concerns about the infant's survival and health, together with the unfamiliar environment of a neonatal intensive care unit, can disrupt the transition to parenthood and may be associated with severe depressive symptoms and childbirth-related post-traumatic stress symptoms.
This single-centre observational study explores the psychological experiences of couples following the birth of an infant before 28 completed weeks of gestation. Its primary objective is to assess childbirth-related post-traumatic stress symptoms using the City Birth Trauma Scale. Secondary objectives are to assess depressive symptoms and explore parental representations, emotional experiences, and psychological functioning.
Couples will be invited to participate during their infant's hospitalisation in the neonatal intensive care unit at Besançon University Hospital, France. Both parents in each couple will participate, with individual assessments taking place at least one month after birth. Each assessment session will last approximately 90 minutes and will include a semi-structured interview using the Clinical Interview for Parents of High-Risk Infants (CLIP), the Rorschach test, and two self-report questionnaires: the Edinburgh Postnatal Depression Scale (EPDS) and the City Birth Trauma Scale, using the appropriate maternal or partner version.
This exploratory study aims to improve understanding of parental psychological vulnerability following extremely preterm birth. In the longer term, its findings may raise healthcare professionals' awareness of maternal and paternal distress and inform approaches to systematic screening for postnatal depression and childbirth-related post-traumatic stress symptoms. Ultimately, this research seeks to support the development of care that addresses both parents' psychological needs and promotes early parent-infant relationships.
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 30 is below the median of 140 across 26 observational studies indexed under Combat Disorders.
Browse Combat Disorders studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 450 studies on the registry; 97 are open to participants now.
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Parent of a baby born at or before 28 weeks' gestation
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Exclusion Criteria:
Childbirth related post-traumatic stress disorder
The City Birth Trauma Scale (City BiTS) is a self-report questionnaire assessing childbirth-related post-traumatic stress symptoms according to DSM-5 criteria. It explores traumatic exposure, re-experiencing, avoidance, negative cognitions and mood, hyperarousal, symptom duration, distress, and functional impairment. Its 20 symptom items are scored from 0 to 3, yielding a total symptom score ranging from 0 to 60, with higher scores indicating greater symptom severity. In this study, the French versions for mothers and partners will be administered following very preterm birth. Total symptom scores will be analysed as a continuous measure. The questionnaire does not independently establish a clinical diagnosis of post-traumatic stress disorder.
Time frame: November 2026 to May 2027
Postnatal Depression
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire assessing depressive symptoms over the past seven days. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 30, with higher scores indicating greater symptom severity. It includes an item assessing thoughts of self-harm. In this study, the French version will be administered to mothers and fathers following very preterm birth to assess parental depressive symptoms. Total scores will be analysed as a continuous measure. The EPDS is a screening instrument and does not establish a clinical diagnosis of depression.
Time frame: November 2026 to May 2027
Parental psychological functioning assessed using the Rorschach test
The Rorschach test is a projective psychological assessment comprising 10 standardized inkblot cards. Participants describe what each inkblot might represent, followed by an inquiry to clarify their responses. Responses are coded and interpreted according to the French School (Paris School) approach, considering perceptual features, response content, and qualitative aspects of the protocol. In this study, it will be used to explore parental psychological functioning, with particular attention to emotional processing, defensive processes, and psychic boundaries in the context of very preterm birth. Findings will contribute to an exploratory assessment of psychological containment, protection, and differentiation. No single overall score or diagnostic cutoff will be used.
Time frame: November 2026 to May 2027
No study locations are listed for this record.
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 Oct 2026. You cannot join it, but the record below documents what was studied.
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