Preventing Childbirth-Related PTSD With Expressive Writing
United States136 participantsStarted 2023-11-08
Plain-language summary
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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
Timeframe: Pre-Intervention and Post-Intervention (within 1 day of treatment)
2
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
Timeframe: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
3
Physiological reactivity as determined from psychophysiologic responses during script-driven traumatic memory recollection of recent childbirth
Timeframe: Month 2 postpartum (up to around Month 3 PP)
4
Clinician-Administered PTSD-5 Scale for DSM 5 (CAPS-5)
Timeframe: Month 2 postpartum (up to around Month 3 PP)