RecruitingNot Applicable

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 range18 Years – 50 Years

SexFEMALE

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.

What they're measuring

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)

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)

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)

Clinician-Administered PTSD-5 Scale for DSM 5 (CAPS-5)

Timeframe: Month 2 postpartum (up to around Month 3 PP)

Trial details

NCT IDNCT05662423

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

Contact for this trial

Sharon Dekel, Ph.D. M.Phil., M.S.

617-726-1352 sdekel@mgh.harvard.edu

View on ClinicalTrials.gov More PTSD (Childbirth-Related) trials

Plain-language summary

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

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)

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)

Clinician-Administered PTSD-5 Scale for DSM 5 (CAPS-5)

Timeframe: Month 2 postpartum (up to around Month 3 PP)