ClinicalTrials.gg
RecruitingNCT07935070SCRIBEUpdated Nov 13, 2026

Written Exposure Therapy for Childbirth-related Post-Traumatic Stress

An interventional study of Written Exposure Therapy in PTSD (Childbirth-Related), PTSD - Post Traumatic Stress Disorder and PTSD, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Feb 2026, registered Oct 2026).
  • Started Feb 2026; still recruiting 9 months later.
Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,663 studies in Stress Disorders, Post-Traumatic with a site in United States — 340 open to participants now, 403 under way, 18 of them phase 3. Stress Disorders, Post-Traumatic · United States.

Planned enrollment
1,284th of 1,490
15 · median 65
Started
2026
with 96 others
No phase
1,011 of 1,663
234 open now
Primary completion
2027-07
later than 204 of 402 live
Registered
1,660th of 1,663
by date

Among the 1,663 studies in Stress Disorders, Post-Traumatic with a site in United States, this one is the 1,284th largest by planned enrollment of the 1,490 interventional ones that give a count, is one of 97 that started in 2026, is one of 1,011 with no phase, reaches primary completion later than 204 of the 402 other live ones, and was the 1,660th registered.

Stress Disorders, Post-Traumatic

2,685 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 603 are open to participants now.

Browse Stress Disorders, Post-Traumatic studies →

Open to participants now

340 of the 1,663 studies in Stress Disorders, Post-Traumatic with a site in United States are open now. Recruiting first, the newest first:

335 more — sign in →

All 340 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 417 Stress Disorders, Post-Traumatic studies recruiting now, 187 (45%) set no upper age limit and 204 (49%) stop at 75 or younger; 63 take children under 18; 89 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

Study summary

In this research study, the investigators hope to determine whether Written Exposure Therapy is a feasible intervention for postpartum women experiencing trauma symptoms related to childbirth to complete. Written Exposure Therapy involves five structured psychotherapy sessions that can be conducted over telehealth.

Read the detailed description

Childbirth-related posttraumatic stress disorder (CB-PTSD) affects approximately one in twenty women after any given childbirth. Postpartum women are faced with unique barriers to accessing and engaging in evidence-based treatment for PTSD. Aside from avoidance, limited time and financial and logistical barriers regarding childcare can make it difficult to engage in long-term therapy or travel to frequent in-person visits. Therefore, postpartum individuals may find a brief telehealth-based intervention, Written Exposure Therapy, to be highly appealing and well-aligned with the demands of postpartum parenting.

Written exposure therapy (WET) is a highly protocolized evidence-based brief psychotherapeutic intervention for the treatment of PTSD that may be promising for women with CB-PTSD. WET consists of 5 treatment sessions. In the first, patients receive brief psychoeducation about PTSD and avoidance as a maladaptive behavior that maintains PTSD symptoms. In each of the five sessions, the patient writes about the same single traumatic event with a focus on feelings and cognitions during the event and how the event has affected their lives. Written exposure therapy can be conducted via telehealth, does not require between-session assignments for patients, is non-inferior to cognitive processing therapy and prolonged exposure therapy, and involves only four total hours of treatment, thus decreasing treatment time by 50-80% compared to other evidence-based psychotherapies for PTSD. This study aims to assess whether postpartum individuals would find such an intervention feasible and be able to maintain engagement to complete the protocol.

03

Conditions studied

  • PTSD (Childbirth-Related)
  • PTSD - Post Traumatic Stress Disorder
  • PTSD
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Birthing individuals
  • 18 years of age or older
  • Living in Massachusetts
  • Can read, write, and speak English
  • Identified a traumatic event exposure related to their childbirth experience
  • Are between one month to two years postpartum
  • Have a probable CB-PTSD diagnosis based on a PCL-5 score ≥ 28.

Exclusion criteria

Exclusion Criteria:

  • Current engagement in another form of trauma-focused psychotherapy
  • No or little memory of the traumatic event
  • Safety concerns including active suicidality, active psychosis, and heavy substance use with inability to cease substance use for at least 2 hours before and after each session.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Written Exposure Therapy

    Behavioral: Written Exposure Therapy

Interventions

  • BehavioralWritten Exposure Therapy

    Written exposure therapy (WET) is a highly protocolized evidence-based brief psychotherapeutic intervention for the treatment of post-traumatic stress disorder (PTSD).

06

What researchers measure

Primary outcomes

  1. Feasibility (retention rate)

    Feasibility will be measured retention rate across five Written Exposure Therapy (WET) sessions. Retention rate is defined as the number of participants who complete all five WET sessions divided by the total number of participants who engaged in at least one WET session. A higher value indicates higher retention. We expect at least 75% of enrolled participants will complete treatment once initiated.

    Time frame: From date of the first WET session until the date of the fifth WET session, withdrawal from the study, or determination of loss to follow-up, whichever occurs first (estimated average assessment period: 6 weeks).

  2. Feasibility (Engagement rate)

    Engagement will be measured as the number of participants who engaged in at least one Written Exposure Therapy session divided by the number of women who enrolled in the study. A higher value indicates higher engagement. We expect at least 75% of enrolled participants will engage in treatment.

    Time frame: From the date of enrollment until the date of the first WET session, withdrawal from the study, or determination of loss to follow-up, whichever occurs first (estimated average assessment period: 4 weeks).

  3. Acceptability (Credibility)

    Credibility will be measured using the pre-intervention credibility/expectancy questionnaire (CEQ) which assesses patient perception of whether treatment seems logical and useful. Credibility is scored as the sum of the first three scale items on the credibility/expectancy questionnaire. Scores range from 3-27, with higher scores indicating greater credibility.

    Time frame: Baseline

  4. Acceptability (Satisfaction)

    Satisfaction will be measured as total score on the post-intervention Client Satisfaction Questionnaire-8 (CSQ-8) survey. Scores range from 8-32, with higher numbers indicating greater satisfaction.

    Time frame: Study exit survey approximately 4 weeks after final WET session.

Secondary outcomes

  1. Changes in PTSD Symptoms Assessed by the PTSD Checklist for DSM-5

    The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0 to 80 and a score at or above 28 is indicative of probable CB-PTSD. A 9 point change represents reliable change.

    Time frame: From enrollment to study exit survey approximately 4 weeks after the final written exposure therapy session.

  2. Changes in EPDS Symptoms Assessed by the Edinburgh Postnatal Depression Scale

    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire used during pregnancy and postpartum to screen for perinatal and postpartum depression. Scores range from 0-30 and a score at or above 10 is indicative of a positive screen for perinatal depression. A 4 point change indicates reliable change.

    Time frame: From enrollment to study exit survey approximately 4 weeks after the final written exposure therapy session.

  3. Changes in PSS Symptoms Assessed by the Perceived Stress Scale

    The Perceived Stress Scale (PSS) is a 10-item self-report questionnaire designed to assess perceptions of recent stress. Scores range from 0 to 40, with higher scores indicating higher perceived stress. A 6 point change indicates reliable change.

    Time frame: From enrollment to study exit survey approximately 4 weeks after the final written exposure therapy session.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to privacy and confidentiality concerns. Aggregate study results will be made publicly available on ClinicalTrials.gov and through publications.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Jul 2027, 17 months after the start.

Of 1,065 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 17 months is below that.

Counting every sponsor, half of 1,093 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2026
First posted
Nov 13, 2026
StartActual
Feb 11, 2026
Primary completionEst.
Jul 31, 2027
CompletionEst.
Aug 31, 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07935070
Collaborators
Harvard Medical School (HMS and HSDM)
Responsible party
Amanda Koire (Principal Investigator, Assistant Professor of Psychiatry, Brigham and Women's Hospital) — Principal investigator
First posted
Nov 13, 2026
Start date
Feb 11, 2026
Primary completion
Jul 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

Amanda Koire, MD, PhD
Contact
akoire@bwh.harvard.edu
(617) 525-3707

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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