Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Expressive Writing about Childbirth
Subgroup of participants will write about their recent childbirth.
  • Behavioral: Expressive Writing about Childbirth
    Participants will write repeatedly about their deepest emotions and thoughts related to their recent childbirth, focusing on the most stressful experiences.
Placebo Comparator
Neutral Writing
Subgroup of participants will write about neutral daily events.
  • Behavioral: Neutral Writing
    Participants will write repeatedly about neutral daily events/tasks not related to childbirth.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Sharon Dekel, Ph.D. M.Phil., M.S.
617-726-1352
sdekel@mgh.harvard.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.