Preventing Childbirth-Related PTSD With Expressive Writing

NCT05662423 | Recruiting DMC

• 1 other identifier: 2022P003320
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD (Childbirth-Related)

Keywords

Mother-Infant Bonding; Postpartum Depression; Postpartum PTSD; Expressive Writing

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

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

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

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

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

• Maternal Attachment Inventory (MAI) total score

  Post-intervention (within 1 day of treatment)

• Maternal Attachment Inventory (MAI) total score

  Month 2 postpartum (up to around Month 3 PP)

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

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

Study Arms (2)

Expressive Writing about Childbirth

ACTIVE COMPARATOR

Subgroup of participants will write about their recent childbirth.

Behavioral: Expressive Writing about Childbirth

Neutral Writing

PLACEBO COMPARATOR

Subgroup of participants will write about neutral daily events.

Behavioral: Neutral Writing

Interventions

Neutral Writing BEHAVIORAL

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

Neutral Writing

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.

Expressive Writing about Childbirth

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 27865585 BACKGROUND

• Pennebaker JW. Expressive Writing in Psychological Science. Perspect Psychol Sci. 2018 Mar;13(2):226-229. doi: 10.1177/1745691617707315. Epub 2017 Oct 9.

  PMID: 28992443 BACKGROUND

• 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.

  PMID: 8347112 BACKGROUND

• 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.

  PMID: 29786116 BACKGROUND

• 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.

  PMID: 28443054 BACKGROUND

• 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.

  PMID: 35640702 BACKGROUND

• 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.

  PMID: 31650283 BACKGROUND

• 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.

  PMID: 32705348 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression, Postpartum

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Psychology

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 22, 2022
• Study Start: November 8, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)