Clinical trial NCT06771817: Empowering Perinatal Adolescents Through Writing
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Traumatic Stress Disorder in Adolescence
PTSD - Post Traumatic Stress Disorder
PTSD and Trauma-related Symptoms
Pregnancy and PTSD
Keywords: PTSD
post-traumatic stress disorder
post-partum
pregnant
adolescent
adolescent PTSD
trauma
written exposure therapy
therapy
adolescent pregnancy
written exposure
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Texas Child Mental Healthcare Consortium (TCMHCC)
First posted: 2025-01-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of Written Exposure Therapy
timeFrame: From enrollment to study exit visit at week 12
Secondary outcomes:
measure: Changes in PTSD Symptom Severity Assessed by the Clinician Administered Scale for PTSD (CAPS-5)
timeFrame: From enrollment to study exit visit at week 12
measure: Changes in PTSD Symptoms Assessed by the PTSD Checklist for DSM-5
timeFrame: From enrollment to study exit visit at week 12
measure: Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: From enrollment to study exit visit at week 12
measure: Changes in Emotional Regulation Assessed by the Difficulties in Emotion Regulation Scale (DERS-16)
timeFrame: From enrollment to study exit visit at week 12
measure: Changes in Anxiety Assessed by the Perinatal Anxiety Screening Scale (PASS)
timeFrame: From enrollment to study exit visit at week 12
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Center for Depression Research and Clinical Care
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Nabila Haque, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmadi SJ, Musavi Z, Samim N, Sadeqi M, Jobson L. Investigating the Feasibility, Acceptability and Efficacy of Using Modified-Written Exposure Therapy in the Aftermath of a Terrorist Attack on Symptoms of Posttraumatic Stress Disorder Among Afghan Adolescent Girls. Front Psychiatry. 2022 Apr 8;13:826633. doi: 10.3389/fpsyt.2022.826633. eCollection 2022.
citation: Nillni YI, Baul TD, Paul E, Godfrey LB, Sloan DM, Valentine SE. Written exposure therapy for treatment of perinatal PTSD among women with comorbid PTSD and SUD: A pilot study examining feasibility, acceptability, and preliminary effectiveness. Gen Hosp Psychiatry. 2023 Jul-Aug;83:66-74. doi: 10.1016/j.genhosppsych.2023.04.013. Epub 2023 Apr 24.