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NCT05662423 · ClinicalTrials.gov record · last posted 2026-07-30

Preventing Childbirth-Related PTSD With Expressive Writing

Study acronym: CARES
StatusCompleted
PhaseNot applicable
Started2023-11-08
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from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-07-31
notable
Trial completed
2026-07-31
critical
Enrollment reduced: 136 → 66 participants
2026-05-23
notable
Primary completion pushed: 2026-05-31 → 2026-07-20
2026-05-23
minor
Completion pushed: 2026-05-31 → 2026-07-31
Trial Details
NCT Number NCT05662423
Lead Sponsor Massachusetts General Hospital
Conditions PTSD (Childbirth-Related)
Enrollment 66 participants
Start Date 2023-11-08
Primary Completion 2026-07-29 (estimated)
Study Completion 2026-07-29 (estimated)
Updated on ClinicalTrials.gov 2026-07-30