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Behavioral Intervention
Written Exposure Therapy for Perinatal PTSD (EMPWR Trial)
Dallas, TX
N/A
Recruiting
Led By Nabila Haque, MD., PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 15-24 at time of screening
Be younger than 65 years old
Must not have
Have current mania, hypomania, or psychosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to study exit visit at week 12
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a therapy called Written Exposure Therapy is a good and acceptable treatment for PTSD in young pregnant and postpartum individuals.
See full description
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly stated for this psychological intervention trial, potential side effects may include temporary increases in distress due to recalling traumatic events during therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 15 and 24 years old.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently experiencing mania, hypomania, or psychosis.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to study exit visit at week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to study exit visit at week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of Written Exposure Therapy
Secondary study objectives
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Changes in Anxiety Assessed by the Perinatal Anxiety Screening Scale (PASS)
Changes in Emotional Regulation Assessed by the Difficulties in Emotion Regulation Scale (DERS-16)
+2 moreSide effects data
From 2023 Phase 2 trial • 16 Patients • NCT0488966485%
Fatigue
69%
Other
38%
Headache
38%
Dizziness
23%
Blurred Vision
15%
Menstrual Irregularity
15%
Difficulty Sleeping
15%
Frequent Urination
15%
Nausea/vomiting
8%
Anxiety
8%
Increased Perspiration
8%
Decreased energy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and Written Exposure Therapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Written Exposure TherapyExperimental Treatment1 Intervention
All participants will receive written exposure therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Written Exposure Therapy
2021
Completed Phase 2
~370
Find a Location
Closest Location:UT Southwestern Center for Depression Research and Clinical Care· Dallas, TX
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,101 Previous Clinical Trials
1,077,060 Total Patients Enrolled
Texas Child Mental Healthcare Consortium (TCMHCC)UNKNOWN
Nabila Haque, MD., PhDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center