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Pen and paper therapy: new study aims to stop PTSD after traumatic birth

NCT ID NCT05662423

Prevention Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests a simple writing exercise for new mothers who had a stressful childbirth. In the days after giving birth, participants write about their experience for 15 minutes a day for three days. The goal is to see if this can prevent post-traumatic stress disorder (PTSD) and help mothers bond with their babies. The study involves 136 women and includes follow-up surveys and assessments two months later.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

66 people

The number who actually took part.

Started

Nov 2023

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

postpartum depression post-traumatic stress disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PTSD (childbirth-related)

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02129, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.