Trials / Recruiting
RecruitingNCT06771817
Empowering Perinatal Adolescents Through Writing
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- Female
- Age
- 15 Years – 24 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Post-Traumatic Stress Disorder in Adolescence
- PTSD - Post Traumatic Stress Disorder
- PTSD and Trauma-related Symptoms
- Pregnancy and PTSD
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-03-26
- Primary completion
- 2026-06-30
- Completion
- 2026-08-31
- First posted
- 2025-01-13
- Last updated
- 2025-03-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06771817. Inclusion in this directory is not an endorsement.