Writing therapy for pregnant and postpartum teens with PTSD
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
NA · University of Texas Southwestern Medical Center · NCT06771817
This study is testing if a writing therapy can help pregnant and new moms with PTSD feel better and improve their emotional and physical health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 15 Years to 24 Years |
| Sex | Female |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06771817 on ClinicalTrials.gov |
What this trial studies
This research investigates the feasibility and acceptability of Written Exposure Therapy (WET) for adolescents and young adults who are pregnant or have recently given birth and are experiencing symptoms of post-traumatic stress disorder (PTSD). Participants will engage in five weekly sessions of WET, where they write about their traumatic experiences and feelings. The study also aims to collect biomarker data through wearable devices to assess changes in emotional and physical well-being before and after the therapy. Additionally, optional electroencephalography (EEG) will be used to explore brain patterns related to the therapy's effects.
Who should consider this trial
Good fit: Ideal candidates are adolescents and young adults aged 15-24 who are pregnant or within one year postpartum and meet criteria for PTSD.
Not a fit: Patients who do not have PTSD or are outside the age range of 15-24 may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce PTSD symptoms and improve emotional functioning in pregnant and postpartum adolescents.
How similar studies have performed: While there is limited research specifically on WET in this demographic, similar trauma-focused therapies have shown promise in treating PTSD in various populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dallas, Texas
- UT Southwestern Center for Depression Research and Clinical Care — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Nabila Haque, MD., PhD — University of Texas Southwestern Medical Center
- Study coordinator: Amrita Ghose, B.S.
- Email: Amrita.Ghose@UTSouthwestern.edu
- Phone: 682-376-8620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-Traumatic Stress Disorder in Adolescence, PTSD - Post Traumatic Stress Disorder, PTSD and Trauma-related Symptoms, Pregnancy and PTSD, PTSD, post-traumatic stress disorder, post-partum, pregnant