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Expressive Writing for Postpartum PTSD (CARES Trial)

N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 2 postpartum
Awards & highlights

Summary

This trial tests an intervention to help new moms bond with their baby & prevent post-birth stress. Participants write & complete surveys, and do a play session with their infant 2 months later.

Who is the study for?
This trial is for women who recently gave birth at Massachusetts General Hospital and are at risk of developing postpartum PTSD, as indicated by a specific distress score. Participants must understand English and be between the ages of 18-50 without severe mental health conditions, substance abuse issues, or recent psychological treatments.Check my eligibility
What is being tested?
The study tests if writing about childbirth (expressive writing) or a neutral topic can prevent PTSD after giving birth. Women will write for three days post-childbirth and complete surveys on their experience and mental health before and after this intervention.See study design
What are the potential side effects?
There may not be direct physical side effects from the interventions since they involve writing exercises. However, discussing traumatic events could potentially cause emotional discomfort or temporary increase in stress.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 2 postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 2 postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
Clinician-Administered PTSD-5 Scale for DSM 5 (CAPS-5)
Physiological reactivity as determined from psychophysiologic responses during script-driven traumatic memory recollection of recent childbirth
Secondary outcome measures
Behavioral mother-infant bonding as determined by a quantitative observational assessment of mother-infant interaction using the Coding Interactive Behavior (CIB)
Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score
Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Expressive Writing about ChildbirthActive Control1 Intervention
Subgroup of participants will write about their recent childbirth.
Group II: Neutral WritingPlacebo Group1 Intervention
Subgroup of participants will write about neutral daily events.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Postpartum PTSD, such as Cognitive Processing Therapy (CPT) and Expressive Writing, work by helping patients process and reframe their traumatic experiences. CPT involves structured sessions where patients learn to challenge and modify unhelpful beliefs related to the trauma, thereby reducing its emotional impact. Expressive Writing, on the other hand, encourages patients to write about their traumatic experiences, which can facilitate emotional expression and cognitive processing. These mechanisms are particularly important for Postpartum PTSD patients as they help in reducing the distress associated with childbirth-related trauma, promoting better mental health and improving maternal-infant bonding.
Unexpected effects of expressive writing on post-disaster distress in the Hurricane Harvey Study: a randomized controlled trial in perinatal women.The effects of PTSD treatment during pregnancy: systematic review and case study.The patient observer: eye-movement desensitization and reprocessing for the treatment of posttraumatic stress following childbirth.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,542 Total Patients Enrolled

Media Library

Expressive Writing about Childbirth Clinical Trial Eligibility Overview. Trial Name: NCT05662423 — N/A
Postpartum PTSD Research Study Groups: Expressive Writing about Childbirth, Neutral Writing
Postpartum PTSD Clinical Trial 2023: Expressive Writing about Childbirth Highlights & Side Effects. Trial Name: NCT05662423 — N/A
Expressive Writing about Childbirth 2023 Treatment Timeline for Medical Study. Trial Name: NCT05662423 — N/A
~58 spots leftby Jan 2025