Clinical trial NCT05662423: Preventing Childbirth-Related PTSD With Expressive Writing
Official title: The Effects of Expressive Writing Following Traumatic Childbirth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD (Childbirth-Related)
Keywords: Mother-Infant Bonding
Postpartum Depression
Postpartum PTSD
Expressive Writing
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test a brief psychological intervention given to individuals in the first days following childbirth who have experienced a potentially stressful childbirth. The treatment is aimed at preventing post-traumatic stress disorder following childbirth and promoting maternal-infant bonding.

In the days following childbirth, participants will be asked to write about their childbirth experience or a neutral event for three consecutive days, for around 15 minutes each day. Additionally, they will complete a short survey before and after the intervention about their birth experience and mental health. Around 2 months postpartum, participants will take part in mental health and physiological assessments, and in a brief play session with their infant.

Detailed description: Childbirth-related PTSD (CB-PTSD) is a debilitating maternal mental disorder that undermines the well-being of mothers and can interfere with bonding with their infants during an important time of infant development. A significant portion of delivering women, particularly those who have experienced complicated deliveries, are at-risk for developing CB-PTSD. Underrepresented minorities are also at higher risk for CB-PTSD. An estimated 240,000 American women are likely to be affected by CB-PTSD each year.

Currently, there is no recommended intervention for individuals exposed to traumatic childbirth in hospitals in the United States. Immediate postpartum interventions delivered to at-risk women that are low-cost, low-burden, and feasible are lacking. This study will attempt to fill this gap in effective treatment. Evidence shows that expressive writing (EW), or briefly disclosing in writing mainly thoughts and feelings about a highly stressful event, can have positive effects on mental and physical health. Therefore, the investigators will test the therapeutic effects of EW about recent childbirth in women at-risk for CB-PTSD.

Eligibility criteria: Inclusion Criteria:

* Women who recently delivered at Massachusetts General Hospital (MGH).
* Women who are at risk for developing CB-PTSD based on their scoring of \>16 on the Peritraumatic Distress Inventory (PDI).

Exclusion Criteria:

* Age \<18 or \>50.
* Preterm delivery (\<37 week gestation) or stillbirth.
* Down's Syndrome, other serious genetic disorder in the newborn, or serious birth defect (e.g., microcephaly, spina bifida).
* Admission to the neonatal intensive care unit (NICU) for more than 24 hours.
* Current diagnosable DSM-5 psychotic or bipolar disorder, or current substance abuse disorder.
* Active suicidality (assessed case by case).
* Present substance abuse as indicated in medical records.
* Severe maternal morbidity (assessed case by case).
* General anesthesia.
* Inability to understand the study procedures, risks, and side effects, or to otherwise give informed consent for participation due to neurological or other reasons.
* Inability to understand English.

Primary outcomes:
measure: Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
timeFrame: Pre-Intervention and Post-Intervention (within 1 day of treatment)
measure: Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
timeFrame: Pre-Intervention and Month 2 postpartum
measure: Physiological reactivity as determined from psychophysiologic responses during script-driven traumatic memory recollection of recent childbirth
timeFrame: Month 2 postpartum
measure: Clinician-Administered PTSD-5 Scale for DSM 5 (CAPS-5)
timeFrame: Month 2 postpartum
Secondary outcomes:
measure: Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score
timeFrame: Pre-Intervention and Post-Intervention (within 1 day of treatment)
measure: Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score
timeFrame: Pre-Intervention and Month 2 postpartum
measure: Maternal Attachment Inventory (MAI) total score
timeFrame: Post-intervention (within 1 day of treatment)
measure: Maternal Attachment Inventory (MAI) total score
timeFrame: Month 2 postpartum
measure: Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score
timeFrame: Pre-Intervention and Post-Intervention (within 1 day of treatment)
measure: Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score
timeFrame: Pre-Intervention and Month 2 postpartum
measure: Change from baseline in the posttraumatic growth inventory (PTG) total score
timeFrame: Pre-Intervention and Post-Intervention (within 1 day of treatment)
measure: Change from baseline in the posttraumatic growth inventory (PTG) total score
timeFrame: Pre-Intervention and Month 2 postpartum
measure: Behavioral mother-infant bonding as determined by a quantitative observational assessment of mother-infant interaction using the Coding Interactive Behavior (CIB)
timeFrame: Month 2 postpartum
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
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citation: Dekel S, Ein-Dor T, Dishy GA, Mayopoulos PA. Beyond postpartum depression: posttraumatic stress-depressive response following childbirth. Arch Womens Ment Health. 2020 Aug;23(4):557-564. doi: 10.1007/s00737-019-01006-x. Epub 2019 Oct 25.
citation: Berman Z, Thiel F, Dishy GA, Chan SJ, Dekel S. Maternal psychological growth following childbirth. Arch Womens Ment Health. 2021 Apr;24(2):313-320. doi: 10.1007/s00737-020-01053-9. Epub 2020 Jul 23.