Preventing Childbirth-Related PTSD With Expressive Writing (CARES)

The Effects of Expressive Writing Following Traumatic Childbirth

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD (Childbirth-Related)
• Intervention / Treatment: Behavioral: Expressive Writing about Childbirth; Behavioral: Neutral Writing

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharon Dekel, Ph.D. M.Phil., M.S.; Phone Number: 617-726-1352; Email: sdekel@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Sharon Dekel, Ph.D., M.Phil., M.S.; Phone Number: 617-726-1352; Email: sdekel@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Expressive Writing about Childbirth; Subgroup of participants will write about their recent childbirth.	Behavioral: Expressive Writing about Childbirth; Participants will write repeatedly about their deepest emotions and thoughts related to their recent childbirth, focusing on the most stressful experiences.
Placebo Comparator: Neutral Writing; Subgroup of participants will write about neutral daily events.	Behavioral: Neutral Writing; Participants will write repeatedly about neutral daily events/tasks not related to childbirth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score	The PCL-5 is the standard self-report measure to assess PTSD symptom severity. It lists the 20 DSM-5 symptoms regarding a specified event (scale: 0-80, higher scores means worse outcome). In this study the event is specified to recent personal childbirth.	Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score	The PCL-5 is the standard self-report measure to assess PTSD symptom severity. It lists the 20 DSM-5 symptoms regarding a specified event (scale: 0-80, higher scores means worse outcome). In this study the event is specified to recent personal childbirth.	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	The posterior probability score will be determined for each participant from a composite of psychophysiological responses during script-driven imagery of recent traumatic childbirth (in comparison to baseline) that includes assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator frontalis facial muscle electromyogram (EMG) responses in microVolts. The responses to each childbirth script will then be compared with a large database of trauma-exposed subjects by means of a discriminant function analysis, which will yield a posterior probability (PrP) score (higher scores means worse outcome). The PrP scores of the two childbirth scripts will be averaged and will serve as a composite measure of physiological responsivity in the analysis.	Month 2 postpartum (up to around Month 3 PP)
Clinician-Administered PTSD-5 Scale for DSM 5 (CAPS-5)	The CAPS-5 is the gold-standard interview to diagnose PTSD. It yields a categorical measure of diagnosis and a severity score (scale: 0-80, higher scores means worse outcomes).	Month 2 postpartum (up to around Month 3 PP)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score	The MIBS is a simply designed short self-report measure for use from day one postpartum, offering one-word descriptors of possible emotions towards the baby to identify early difficulties in bonding (scale: 0-24, higher scores means worse outcome). This will be assessed in relation to recent childbirth.	Pre-Intervention and Post-Intervention (within 1 day of treatment)
Maternal Attachment Inventory (MAI) total score	The MAI self-report asks about maternal feelings toward and perceptions of the infant; it is considered a robust tool to measure problems in mother-baby relationship (scale: 26-104, higher scores means better outcome). This will be assessed in relation to recent childbirth.	Post-intervention (within 1 day of treatment)
Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score	The EPDS is a brief 10-item self-report measure (scale: 0-30, higher scores means worse outcome). It recommended for assessing for maternal depression in routine obstetrics care in the US.	Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the posttraumatic growth inventory (PTG) total score	The PTGI is a 21-item self-report measures that in used in research to assess positive change following a specific (potentially traumatic) event in regard to new possibilities, relating to others, personal strength, spiritual change, and appreciation of Life (scale: 0-125, higher scores means better outcome). This will be assessed in relation to recent childbirth.	Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score	The MIBS is a simply designed short self-report measure for use from day one postpartum, offering one-word descriptors of possible emotions towards the baby to identify early difficulties in bonding (scale: 0-24, higher scores means worse outcome).This will be assessed in relation to recent childbirth.	Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Maternal Attachment Inventory (MAI) total score	The MAI asks about maternal feelings toward and perceptions of the infant; it is considered a robust tool to measure problems in mother-baby relationship (scale: 26-104, higher scores means better outcome).This will be assessed in relation to recent childbirth.	Month 2 postpartum (up to around Month 3 PP)
Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score	The EPDS is a brief 10-item self-report measure (scale: 0-30, higher scores means worse outcome). It recommended for assessing for maternal depression in routine obstetrics care in the US.	Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Change from baseline in the posttraumatic growth inventory (PTG) total score	The PTGI is a 21-item self-report measures that in used in research to assess positive change following a specific (potentially traumatic) event in regard to new possibilities, relating to others, personal strength, spiritual change, and appreciation of Life (scale: 0-125, higher scores means better outcome). This will be assessed in relation to recent childbirth.	Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Behavioral mother-infant bonding as determined by a quantitative observational assessment of mother-infant interaction using the Coding Interactive Behavior (CIB)	Mother-infant bonding behavior will be observed during a 5-min free-play session and coded using the well-validated CIB. The CIB is a global rating system that looks at affective states and interactive styles. Using video-recorded material, the CIB is broken down into 33 codes (18 parent, 8 child, and 7 dyad) rated on a 1-5 scale. Meaningful theory-based constructs, for example, maternal sensitivity (higher scores better outcome), will be used in final analysis	Month 2 postpartum (up to around Month 3 PP)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• Yildiz PD, Ayers S, Phillips L. The prevalence of posttraumatic stress disorder in pregnancy and after birth: A systematic review and meta-analysis. J Affect Disord. 2017 Jan 15;208:634-645. doi: 10.1016/j.jad.2016.10.009. Epub 2016 Oct 27.
• Pennebaker JW. Expressive Writing in Psychological Science. Perspect Psychol Sci. 2018 Mar;13(2):226-229. doi: 10.1177/1745691617707315. Epub 2017 Oct 9.
• Pennebaker JW. Putting stress into words: health, linguistic, and therapeutic implications. Behav Res Ther. 1993 Jul;31(6):539-48. doi: 10.1016/0005-7967(93)90105-4.
• Dekel S, Thiel F, Dishy G, Ashenfarb AL. Is childbirth-induced PTSD associated with low maternal attachment? Arch Womens Ment Health. 2019 Feb;22(1):119-122. doi: 10.1007/s00737-018-0853-y. Epub 2018 May 21.
• Dekel S, Stuebe C, Dishy G. Childbirth Induced Posttraumatic Stress Syndrome: A Systematic Review of Prevalence and Risk Factors. Front Psychol. 2017 Apr 11;8:560. doi: 10.3389/fpsyg.2017.00560. eCollection 2017.
• Chan SJ, Thiel F, Kaimal AJ, Pitman RK, Orr SP, Dekel S. Validation of childbirth-related posttraumatic stress disorder using psychophysiological assessment. Am J Obstet Gynecol. 2022 Oct;227(4):656-659. doi: 10.1016/j.ajog.2022.05.051. Epub 2022 May 29.
• Dekel S, Ein-Dor T, Dishy GA, Mayopoulos PA. Beyond postpartum depression: posttraumatic stress-depressive response following childbirth. Arch Womens Ment Health. 2020 Aug;23(4):557-564. doi: 10.1007/s00737-019-01006-x. Epub 2019 Oct 25.
• Berman Z, Thiel F, Dishy GA, Chan SJ, Dekel S. Maternal psychological growth following childbirth. Arch Womens Ment Health. 2021 Apr;24(2):313-320. doi: 10.1007/s00737-020-01053-9. Epub 2020 Jul 23.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Postpartum Depression; Expressive Writing; Mother-Infant Bonding; Postpartum PTSD
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Stress Disorders, Traumatic; Depressive Disorder; Depression, Postpartum; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2022P003320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No