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NCT Number: NCT05662423

Preventing Childbirth-Related PTSD With Expressive Writing

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.

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Key information

Conditions

PTSD (Childbirth-Related) Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

617-726-1352

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Expressive Writing about Childbirth

Behavioral

Participants will write repeatedly about their deepest emotions and thoughts related to their recent childbirth, focusing on the most stressful experiences.

Neutral writing

Behavioral

Participants will write repeatedly about neutral daily events/tasks not related to childbirth.

Primary outcomes

  1. Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score

    Time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)

    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.

  2. Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score

    Time frame: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)

    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.

  3. Physiological reactivity as determined from psychophysiologic responses during script-driven traumatic memory recollection of recent childbirth

    Time frame: Month 2 postpartum (up to around Month 3 PP)

    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.

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

    Time frame: Month 2 postpartum (up to around Month 3 PP)

    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).

Secondary outcomes

  1. Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score

    Time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)

    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.

  2. Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score

    Time frame: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)

    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.

  3. Maternal Attachment Inventory (MAI) total score

    Time frame: Post-intervention (within 1 day of treatment)

    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.

  4. Maternal Attachment Inventory (MAI) total score

    Time frame: Month 2 postpartum (up to around Month 3 PP)

    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.

  5. Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score

    Time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)

    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.

  6. Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score

    Time frame: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)

    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.

  7. Change from baseline in the posttraumatic growth inventory (PTG) total score

    Time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)

    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.

  8. Change from baseline in the posttraumatic growth inventory (PTG) total score

    Time frame: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)

    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.

  9. Behavioral mother-infant bonding as determined by a quantitative observational assessment of mother-infant interaction using the Coding Interactive Behavior (CIB)

    Time frame: Month 2 postpartum (up to around Month 3 PP)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

617-726-1352

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

The Effects of Expressive Writing Following Traumatic Childbirth

Acronym: CARES

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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