NCT05662423 Preventing Childbirth-Related PTSD With Expressive Writing
| NCT ID | NCT05662423 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | PTSD (Childbirth-Related) |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2023-11-08 |
| Primary Completion | 2026-07-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2023-11-08 with a primary completion date of 2026-07-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05662423 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying PTSD (Childbirth-Related). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05662423 currently recruiting?
Yes, NCT05662423 is actively recruiting participants. Contact the research team at sdekel@mgh.harvard.edu for enrollment information.
Where is the NCT05662423 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05662423 clinical trial?
NCT05662423 is sponsored by Massachusetts General Hospital. The trial plans to enroll 136 participants.
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