Preventing Childbirth-Related PTSD With Expressive Writing (CARES)

Mass General Brigham

Status: Enrolling

Conditions: PTSD (Childbirth-Related)

Treatments: Behavioral: Neutral Writing; Behavioral: Expressive Writing about Childbirth

Study type: Interventional

Funder types: Other

Identifiers

NCT05662423

2022P003320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

136 participants in 2 patient groups, including a placebo group

Expressive Writing about Childbirth

Active Comparator group

Description:

Subgroup of participants will write about their recent childbirth.

Treatment:

Behavioral: Expressive Writing about Childbirth

Neutral Writing

Placebo Comparator group

Description:

Subgroup of participants will write about neutral daily events.

Treatment:

Behavioral: Neutral Writing