The Effects of Expressive Writing Following Traumatic Childbirth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •Age <18 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 1 week or infant that is not medically healthy.
- •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.
研究组 & 干预措施
Expressive Writing about Childbirth
Subgroup of participants will write about their recent childbirth.
干预措施: Expressive Writing about Childbirth (Behavioral)
Neutral Writing
Subgroup of participants will write about neutral daily events.
干预措施: Neutral Writing (Behavioral)
结局指标
主要结局
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
时间窗: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
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.
Physiological reactivity as determined from psychophysiologic responses during script-driven traumatic memory recollection of recent childbirth
时间窗: Month 2 postpartum (up to around Month 3 PP)
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.
Clinician-Administered PTSD-5 Scale for DSM 5 (CAPS-5)
时间窗: Month 2 postpartum (up to around Month 3 PP)
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).
次要结局
- Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score(Pre-Intervention and Month 2 postpartum (up to around Month 3 PP))
- Maternal Attachment Inventory (MAI) total score(Month 2 postpartum (up to around Month 3 PP))
- Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score(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)(Month 2 postpartum (up to around Month 3 PP))
- Change from baseline in the posttraumatic growth inventory (PTG) total score(Pre-Intervention and Month 2 postpartum (up to around Month 3 PP))
研究者
Sharon Dekel, PhD
Assistant Professor in Psychology
Massachusetts General Hospital