Empowering Perinatal Adolescents Through Writing

Not Applicable

Recruiting

• Conditions: Post-Traumatic Stress Disorder in Adolescence; PTSD - Post Traumatic Stress Disorder; PTSD and Trauma-related Symptoms; Pregnancy and PTSD

• Registration Number: NCT06771817
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Study Start: 2025-03-26
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-06-30
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of Written Exposure Therapy	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.

Secondary Outcome Measures

Name	Time	Method
Changes in PTSD Symptom Severity Assessed by the Clinician Administered Scale for PTSD (CAPS-5)	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.
Changes in PTSD Symptoms Assessed by the PTSD Checklist for DSM-5	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.
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)	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.
Changes in Emotional Regulation Assessed by the Difficulties in Emotion Regulation Scale (DERS-16)	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.
Changes in Anxiety Assessed by the Perinatal Anxiety Screening Scale (PASS)	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.

Trial Locations

Locations (1)

UT Southwestern Center for Depression Research and Clinical Care; 🇺🇸 Dallas, Texas, United States