Empowering Perinatal Adolescents Through Writing

NCT06771817 | Active Not Recruiting

• 2 other identifiers: STU-2024-1115NECMHR01-FY24 -060
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of Written Exposure Therapy

  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 Outcomes (5)

• Changes in PTSD Symptom Severity Assessed by the Clinician Administered Scale for PTSD (CAPS-5)

  From enrollment to study exit visit at week 12

• Changes in PTSD Symptoms Assessed by the PTSD Checklist for DSM-5

  From enrollment to study exit visit at week 12

• Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)

  From enrollment to study exit visit at week 12

• Changes in Emotional Regulation Assessed by the Difficulties in Emotion Regulation Scale (DERS-16)

  From enrollment to study exit visit at week 12

• Changes in Anxiety Assessed by the Perinatal Anxiety Screening Scale (PASS)

  From enrollment to study exit visit at week 12

Study Arms (1)

Written Exposure Therapy

EXPERIMENTAL

All participants will receive written exposure therapy

Behavioral: Written Exposure Therapy

Interventions

Written Exposure Therapy BEHAVIORAL

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.

Written Exposure Therapy

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Stated willingness to comply with all study procedures and availability for the duration of the study
• Have been referred by a clinician to the study or receiving standard of care treatment for pregnancy or post-partum follow-up
• Aged 15-24 at time of screening
• Either have Gestational age \>12 weeks or be \<1 year postpartum at time of screening
• 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
• 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.
• Have the ability to complete clinical evaluations and self-report measures.
• Meet diagnostic or subthreshold criteria for PTSD.

You may not qualify if:

• 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.
• Have current mania, hypomania, or psychosis
• Be at serious suicidal risk that cannot be managed in the outpatient setting
• Pervasive or intellectual developmental disorder requiring substantial or very substantial support.
• Currently receiving or having received course of exposure-based therapy (e.g. WET, PE, CPT, or TF-CBT) in the past six months

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Texas Child Mental Healthcare Consortium (TCMHCC): collaborator

Study Sites (1)

UT Southwestern Center for Depression Research and Clinical Care

Dallas, Texas, 75247, United States

Location

Related Publications (2)

• 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.

  PMID: 35463492 BACKGROUND

• 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.

  PMID: 37119780 BACKGROUND

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Nabila Haque, MD., PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident-Psychiatry

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: March 26, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)