Empowering Perinatal Adolescents Through Writing (EMPWR)

April 23, 2026 updated by: Nabila Haque, University of Texas Southwestern Medical Center

Feasibility and Preliminary Effectiveness of Written Exposure Therapy (WET) for Pregnant or Postpartum Adolescents and Youth With Post-Traumatic Stress Disorder (PTSD) in an Open Pilot Trial

This is a feasibility and acceptability study of Written Exposure Therapy (WET) for PTSD in pregnant and postpartum adolescents and youth with PTSD.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The main goal of this research study is to investigate whether a short trauma-focused therapy involving writing is something teens and young adults who are pregnant or recently had a baby and have symptoms related to post-traumatic stress disorder (PTSD) are able to complete. This study is specifically examining the feasibility and acceptability of Written Exposure Therapy (WET) as a treatment in this population. WET is a type of therapy where people write about a traumatic experience they have gone through, and their feelings about the event. Doing this over several sessions may help some people reduce how distressing the memory is to them over time.

In addition, this study aims to investigate if WET can reduce symptoms related to PTSD in teens and young adults who are pregnant or have had a baby in the last year. The study will also explore if it is possible to gather enough information on measurements like heart rate and sleep patterns with smart watches in the same population, to look at brain patterns before and after the therapy, and to see if WET can improve emotions, functioning, and relationships in pregnant and post-partum individuals.

Prior to initiating the course of WET, participants will undergo screening procedures to evaluate eligibility. Those eligible will complete 5 sessions of written exposure therapy, one session per week and biomarker data will be collected via a wearable device. Participants will also undergo optional electroencephalography (EEG) as well as self-report and clinician-rated assessments. Follow-up visits will be conducted at 4, 8 and 12 weeks post-baseline (post-treatment for WET), with weekly assessments.

The baseline visit must be done in-person in order to set up the smart watch. If participants choose to undergo electroencephalography, they will be required to come in-person for the procedure.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247
        • UT Southwestern Center for Depression Research and Clinical Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Stated willingness to comply with all study procedures and availability for the duration of the study
  2. Have been referred by a clinician to the study or receiving standard of care treatment for pregnancy or post-partum follow-up
  3. Aged 15-24 at time of screening
  4. Either have Gestational age >12 weeks or be <1 year postpartum at time of screening
  5. Able and willing to provide informed consent if 18 years of age or above or the legal guardian must be able and willing to provide informed consent if participant is less than 18 years of age and participant willing and able to provide assent if less than 18 years of age
  6. Able to read, write and speak in English and Spanish; if the participant is under age 18, parents must be able to understand spoken or written English or Spanish.
  7. Have the ability to complete clinical evaluations and self-report measures.
  8. Meet diagnostic or subthreshold criteria for PTSD.

Exclusion Criteria:

  1. Have any condition for which, in the opinion of the investigator or designee, study participation would not be in their best interest (including but not limited to cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments.
  2. Have current mania, hypomania, or psychosis
  3. Be at serious suicidal risk that cannot be managed in the outpatient setting
  4. Pervasive or intellectual developmental disorder requiring substantial or very substantial support.
  5. Currently receiving or having received course of exposure-based therapy (e.g. WET, PE, CPT, or TF-CBT) in the past six months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Written Exposure Therapy
All participants will receive written exposure therapy
Behavioral: Written Exposure Therapy
WET may be an optimal treatment for pregnant or postpartum adolescents and youth with PTSD in a low resource setting. WET addresses many of the barriers above. It is delivered in just 5 sessions, with no homework, and may promote a sense of self-efficacy in adolescents and youth due to the nature of writing assignments and brief therapist involvement. It is attractive in resource-poor settings because just 10-15 min of direct therapist time per follow-up session is needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Written Exposure Therapy
Time Frame: From enrollment to study exit visit at week 12
Feasibility will be assessed based on recruitment, retention and treatment adherence rates. Acceptability will be evaluated through participant feedback, including satisfaction with the intervention and willingness to engage in treatment. The primary outcome will be the percentage of participants who complete treatment within 4 weeks, for a 12-week study period. We expect at least 70% of participants will be able to complete treatment within 4 weeks.
From enrollment to study exit visit at week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in PTSD Symptom Severity Assessed by the Clinician Administered Scale for PTSD (CAPS-5)
Time Frame: From enrollment to study exit visit at week 12
The Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA-5) is a 30-item clinician-administered PTSD scale based upon DSM-5 criteria for children and adolescents ages 7 and above. It is a modified version of the CAPS-5 that includes age-appropriate items and picture response options. It will be used to diagnose PTSD or subthreshold PTSD and obtain data on the frequency and severity of PTSD symptoms. The worst traumatic event identified in the LSC-R from baseline will be used for all CAPS-CA-5 administrations. Preliminary effectiveness will be measured by assessing changes in the CAPS-5 score at 4,8, and 12 weeks after baseline visit.
From enrollment to study exit visit at week 12
Changes in PTSD Symptoms Assessed by the PTSD Checklist for DSM-5
Time Frame: From enrollment to study exit visit at week 12
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 above 21 is indicative of probable PTSD. A 10-20 point change represents clinically significant change.
From enrollment to study exit visit at week 12
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: From enrollment to study exit visit at week 12
Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report measure to evaluate sleep quality, duration, and functioning.
From enrollment to study exit visit at week 12
Changes in Emotional Regulation Assessed by the Difficulties in Emotion Regulation Scale (DERS-16)
Time Frame: From enrollment to study exit visit at week 12
The Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) is a 16-item assessment of emotion regulation difficulties, rated on a 5-point Likert scale.
From enrollment to study exit visit at week 12
Changes in Anxiety Assessed by the Perinatal Anxiety Screening Scale (PASS)
Time Frame: From enrollment to study exit visit at week 12
The Perinatal Anxiety Screening Scale (PASS) is a 31-item self-rated questionnaire investigating anxiety symptoms during the last month in child-bearing women. Scores may range 0-93 and cutoff for clinical anxiety is ≥26.
From enrollment to study exit visit at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Texas Child Mental Healthcare Consortium (TCMHCC)

Investigators

  • Principal Investigator: Nabila Haque, MD., PhD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2024-1115
  • NECMHR01-FY24 -060 (Other Grant/Funding Number: Texas Child Mental Healthcare Consortium (TCMHCC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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