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 (with the option of up to around Month 3 PP), participants will take part in mental health and physiological assessments, and in a brief play session with their infant.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
136
Participants will write repeatedly about their deepest emotions and thoughts related to their recent childbirth, focusing on the most stressful experiences.
Participants will write repeatedly about neutral daily events/tasks not related to childbirth.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGChange from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
The PCL-5 is the standard self-report measure to assess PTSD symptom severity. It lists the 20 DSM-5 symptoms regarding a specified event (scale: 0-80, higher scores means worse outcome). In this study the event is specified to recent personal childbirth.
Time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
The PCL-5 is the standard self-report measure to assess PTSD symptom severity. It lists the 20 DSM-5 symptoms regarding a specified event (scale: 0-80, higher scores means worse outcome). In this study the event is specified to recent personal childbirth.
Time frame: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Physiological reactivity as determined from psychophysiologic responses during script-driven traumatic memory recollection of recent childbirth
The posterior probability score will be determined for each participant from a composite of psychophysiological responses during script-driven imagery of recent traumatic childbirth (in comparison to baseline) that includes assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator frontalis facial muscle electromyogram (EMG) responses in microVolts. The responses to each childbirth script will then be compared with a large database of trauma-exposed subjects by means of a discriminant function analysis, which will yield a posterior probability (PrP) score (higher scores means worse outcome). The PrP scores of the two childbirth scripts will be averaged and will serve as a composite measure of physiological responsivity in the analysis.
Time frame: Month 2 postpartum (up to around Month 3 PP)
Clinician-Administered PTSD-5 Scale for DSM 5 (CAPS-5)
The CAPS-5 is the gold-standard interview to diagnose PTSD. It yields a categorical measure of diagnosis and a severity score (scale: 0-80, higher scores means worse outcomes).
Time frame: Month 2 postpartum (up to around Month 3 PP)
Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score
The MIBS is a simply designed short self-report measure for use from day one postpartum, offering one-word descriptors of possible emotions towards the baby to identify early difficulties in bonding (scale: 0-24, higher scores means worse outcome). This will be assessed in relation to recent childbirth.
Time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score
The MIBS is a simply designed short self-report measure for use from day one postpartum, offering one-word descriptors of possible emotions towards the baby to identify early difficulties in bonding (scale: 0-24, higher scores means worse outcome).This will be assessed in relation to recent childbirth.
Time frame: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Maternal Attachment Inventory (MAI) total score
The MAI self-report asks about maternal feelings toward and perceptions of the infant; it is considered a robust tool to measure problems in mother-baby relationship (scale: 26-104, higher scores means better outcome). This will be assessed in relation to recent childbirth.
Time frame: Post-intervention (within 1 day of treatment)
Maternal Attachment Inventory (MAI) total score
The MAI asks about maternal feelings toward and perceptions of the infant; it is considered a robust tool to measure problems in mother-baby relationship (scale: 26-104, higher scores means better outcome).This will be assessed in relation to recent childbirth.
Time frame: Month 2 postpartum (up to around Month 3 PP)
Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score
The EPDS is a brief 10-item self-report measure (scale: 0-30, higher scores means worse outcome). It recommended for assessing for maternal depression in routine obstetrics care in the US.
Time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)
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Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score
The EPDS is a brief 10-item self-report measure (scale: 0-30, higher scores means worse outcome). It recommended for assessing for maternal depression in routine obstetrics care in the US.
Time frame: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Change from baseline in the posttraumatic growth inventory (PTG) total score
The PTGI is a 21-item self-report measures that in used in research to assess positive change following a specific (potentially traumatic) event in regard to new possibilities, relating to others, personal strength, spiritual change, and appreciation of Life (scale: 0-125, higher scores means better outcome). This will be assessed in relation to recent childbirth.
Time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the posttraumatic growth inventory (PTG) total score
The PTGI is a 21-item self-report measures that in used in research to assess positive change following a specific (potentially traumatic) event in regard to new possibilities, relating to others, personal strength, spiritual change, and appreciation of Life (scale: 0-125, higher scores means better outcome). This will be assessed in relation to recent childbirth.
Time frame: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Behavioral mother-infant bonding as determined by a quantitative observational assessment of mother-infant interaction using the Coding Interactive Behavior (CIB)
Mother-infant bonding behavior will be observed during a 5-min free-play session and coded using the well-validated CIB. The CIB is a global rating system that looks at affective states and interactive styles. Using video-recorded material, the CIB is broken down into 33 codes (18 parent, 8 child, and 7 dyad) rated on a 1-5 scale. Meaningful theory-based constructs, for example, maternal sensitivity (higher scores better outcome), will be used in final analysis
Time frame: Month 2 postpartum (up to around Month 3 PP)