Preventing Childbirth-Related PTSD With Expressive Writing

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Expressive Writing Following Traumatic Childbirth

Conditions
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PTSD (Childbirth-Related)

Intervention / Treatment
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* Behavioral: Expressive Writing about Childbirth
* Behavioral: Neutral Writing


Participation Criteria
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Eligibility Criteria
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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. Current PTSD from another traumatic event. 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. Enrollment in psychological mental health treatment during active study (not pertaining to brief check-in encounters with mental health professionals).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Expressive Writing about Childbirth<br>Subgroup of participants will write about their recent childbirth. | Behavioral: Expressive Writing about Childbirth<br>* Participants will write repeatedly about their deepest emotions and thoughts related to their recent childbirth, focusing on the most stressful experiences.<br>|
| Placebo Comparator: Neutral Writing<br>Subgroup of participants will write about neutral daily events. | Behavioral: Neutral Writing<br>* Participants will write repeatedly about neutral daily events/tasks not related to childbirth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 4 postpartum baseline and Day 8 postpartum | 
| 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. | Day 4 postpartum baseline and Month 2 postpartum | 
| 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. | Month 2 postpartum | 
| 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). | Month 2 postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 4 postpartum baseline and Day 8 postpartum | 
| 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. | Day 4 postpartum baseline and Month 2 postpartum | 
| 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. | Day 8 postpartum | 
| 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. | Month 2 postpartum | 
| 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. | Day 4 postpartum baseline and Day 8 postpartum | 
| 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. | Day 4 postpartum baseline and Month 2 postpartum | 
| 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. | Day 4 postpartum baseline and Day 8 postpartum | 
| 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. | Day 4 postpartum baseline and Month 2 postpartum | 
| 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 | Month 2 postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mother-Infant Bonding, Postpartum Depression, Postpartum PTSD, Expressive Writing