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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

CARES Trial 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.

CARES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 2 postpartum

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

CARES 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,505 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over the age of forty-five eligible to participate in this clinical experiment?

"Participation in this study is only open to individuals aged between 18 and 50."

Answered by AI

Who would be the ideal participants for this medical experiment?

"This clinical trial targets patients between 18-50 years old suffering from childbirth related PTSD, and is currently seeking 136 participants."

Answered by AI

Is it currently possible to enroll in this research experiment?

"Per the available information on clinicaltrials.gov, this particular trial has ceased to accept new participants since its last update on December 14th 2022. It was initially posted on March 1st 2023. Nonetheless, there are still multiple other trials recruiting patients at present."

Answered by AI

What objectives are researchers hoping to accomplish with this investigation?

"This trial will be evaluated at 4 days postpartum and 2 months postpartum, assessing physiological reactivity during a traumatic memory of childbirth. Secondary aims encompass the Maternal Attachment Inventory (MAI) total score, Edinburgh Postnatal Depression Scale (EPDS) total score, and Posttraumatic Growth Inventory (PTG) total score to determine mother-baby relationships, maternal depression levels, and positive change following childbirth respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preventing Childbirth-Related PTSD With Expressive Writing

Sharon Dekel, PhD 2023. "Preventing Childbirth-Related PTSD With Expressive Writing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05662423.