Written Exposure Therapy for Perinatal PTSD
(EMPWR Trial)
Recruiting in Palo Alto (17 mi)
Overseen byNabila Haque, MD., PhD
Age: < 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Texas Southwestern Medical Center
Disqualifiers: Cognitive impairment, Psychosis, Suicidal risk, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a feasibility and acceptability study of Written Exposure Therapy (WET) for PTSD in pregnant and postpartum adolescents and youth with PTSD.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment Written Exposure Therapy for perinatal PTSD?
Written Exposure Therapy (WET) has been shown to be effective for treating PTSD in various groups, including veterans and individuals with different traumatic experiences. It is a brief, 5-session treatment that has demonstrated significant improvements in PTSD symptoms and is comparable to other established therapies like Cognitive Processing Therapy.
12345Is Written Exposure Therapy safe for humans?
Written Exposure Therapy (WET) is generally considered safe for humans, as it has been used in various studies for treating posttraumatic stress disorder (PTSD) and has shown to be well-tolerated by participants, including veterans and pregnant women with PTSD.
12345How is Written Exposure Therapy different from other treatments for perinatal PTSD?
Written Exposure Therapy (WET) is unique because it is a brief, 5-session treatment that doesn't require homework between sessions, making it more efficient and accessible compared to other PTSD therapies. It has been shown to be effective in reducing PTSD symptoms, even among pregnant women with additional challenges like substance use disorder.
13456Eligibility Criteria
This trial is for pregnant or postpartum adolescents and youth aged 15-24 with PTSD or subthreshold PTSD. Participants must be referred by a clinician, able to read and write in English or Spanish, willing to follow study procedures, and have parental consent if under 18. Excluded are those with conditions that could affect the study's outcome like cognitive impairments, current mania/psychosis, substantial developmental disorders, recent exposure-based therapy, or serious suicidal risk.Inclusion Criteria
Referred by a clinician to the study or receiving standard of care treatment for pregnancy or post-partum follow-up
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
Stated willingness to comply with all study procedures and availability for the duration of the study
+5 more
Exclusion Criteria
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
I am currently experiencing mania, hypomania, or psychosis.
Pervasive or intellectual developmental disorder requiring substantial or very substantial support
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants complete 5 sessions of Written Exposure Therapy, one session per week, with biomarker data collection via a wearable device
5 weeks
5 visits (in-person)
Follow-up
Participants are monitored for changes in PTSD symptoms, sleep quality, emotional regulation, and anxiety at 4, 8, and 12 weeks post-baseline
12 weeks
3 visits (in-person or virtual)
Participant Groups
The trial studies Written Exposure Therapy (WET) for treating PTSD in perinatal adolescents. It aims to determine how feasible and acceptable WET is as a treatment option during pregnancy or within one year postpartum.
1Treatment groups
Experimental Treatment
Group I: Written Exposure TherapyExperimental Treatment1 Intervention
All participants will receive written exposure therapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UT Southwestern Center for Depression Research and Clinical CareDallas, TX
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Who Is Running the Clinical Trial?
University of Texas Southwestern Medical CenterLead Sponsor
Texas Child Mental Healthcare Consortium (TCMHCC)Collaborator
References
Written exposure therapy for treatment of perinatal PTSD among women with comorbid PTSD and SUD: A pilot study examining feasibility, acceptability, and preliminary effectiveness. [2023]This pilot open trial examined the feasibility, acceptability, and preliminary effectiveness of Written Exposure Therapy (WET), a 5-session evidence-based intervention for posttraumatic stress disorder (PTSD) during pregnancy. Participants were pregnant women with comorbid PTSD and substance use disorder (SUD) receiving prenatal care in a high risk obstetrics-addictions clinic.
Effectiveness of written exposure therapy for posttraumatic stress disorder in the Department of Veterans Affairs Healthcare System. [2023]Written Exposure Therapy (WET) for posttraumatic stress disorder (PTSD) has been shown to be efficacious in clinical trials; however, research is needed to determine WET's effectiveness in clinical practice settings. Additionally, research is needed to understand whether patient characteristics or treatment delivery format moderate outcomes.
Brief novel therapies for PTSD: Written Exposure Therapy. [2022]Written Exposure Therapy (WET) is a 5-session exposure-based intervention for the treatment of posttraumatic stress disorder (PTSD). WET was developed through a series of systematic evaluations of the expressive writing procedure. It is an efficient intervention, requiring limited patient and therapist time and no between-session assignments. The treatment results in statistically and clinically significant symptom change among individuals, including veterans, with PTSD.
Long-term treatment gains of a brief exposure-based treatment for PTSD. [2022]Written exposure therapy (WET) is a 5-session PTSD treatment that may address barriers in treatment for posttraumatic stress disorder (PTSD) given its brevity and tolerability. A recent study found outcomes for WET were non-inferior to outcomes from Cognitive Processing Therapy (CPT) through 36 weeks from first treatment session (Sloan, Marx, Lee, & Resick, 2018); the current study examined whether treatment gains were maintained through 60 weeks from first session, and also evaluated both treatments' effect on depressive symptoms.
An Open Pilot Trial of Written Exposure Therapy for Patients With Post-Traumatic Stress Disorder in Korea. [2021]Written exposure therapy (WET) is exposure therapy for post-traumatic stress disorder (PTSD). Compared to evidencebased treatments for PTSD, WET requires only five sessions, has a shorter session time, and no between-session assignments. The current study examined the efficacy of WET among Korean patients with PTSD due to various traumatic events on PTSD symptoms, depressive symptoms, and global functioning levels.
Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. [2022]Posttraumatic stress disorder (PTSD) occurs more commonly among military service members than among civilians; however, despite the availability of several evidence-based treatments, there is a need for more efficient evidence-based PTSD treatments to better address the needs of service members. Written exposure therapy is a brief PTSD intervention that consists of 5 sessions with no between-session assignments, has demonstrated efficacy, and is associated with low treatment dropout rates, but prior randomized clinical trials of this intervention have focused on civilian populations.