What side effects are associated with this type of intervention?

Common treatments for postpartum PTSD that are similar to expressive writing include cognitive processing therapy (CPT) and other forms of cognitive-behavioral therapy (CBT). These treatments generally have minimal physical side effects but can sometimes lead to temporary increases in distress or anxiety as patients confront and process traumatic memories. Emotional expression interventions, like expressive writing, may also cause short-term emotional discomfort as individuals articulate their traumatic experiences. However, these side effects are typically transient and are outweighed by the long-term benefits of reduced PTSD symptoms and improved emotional well-being.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for postpartum PTSD in the provided context. However, treatments for PTSD generally include cognitive-behavioral therapies (CBT) such as cognitive processing therapy and emotional expression techniques, which are similar to the expressive writing intervention being studied. Pharmacological treatments often involve selective serotonin reuptake inhibitors (SSRIs) like sertraline and paroxetine, which are FDA-approved for PTSD.

What other types of research exist?

Promising novel alternatives to Expressive Writing for Postpartum PTSD patients include: 1) Cognitive Behavioral Therapy (CBT), which has been effective in reducing PTSD symptoms and improving mental health outcomes. 2) Mindfulness-Based Stress Reduction (MBSR), which has shown benefits in managing stress and improving psychological well-being. 3) Music Therapy, which can reduce anxiety and improve mood. 4) Video Colposcopy, which has been effective in reducing anxiety during medical procedures. These alternatives offer diverse approaches to managing PTSD symptoms and improving overall mental health.

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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 if writing about childbirth can help women who had a stressful delivery. The goal is to prevent PTSD and improve bonding with their babies. Writing helps by allowing them to process their emotions and reduce stress.

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

Do I qualify?Apply below to find out

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

2,993 Previous Clinical Trials

13,230,585 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

~39 spots leftby Jan 2025

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