Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center

Prevention of Posttraumatic Stress: A Randomized Controlled Trial of Brief Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center

The purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (PTSD) and a number of other concerns following injury.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Posttraumatic Stress Disorder; Traumatic Injury
• Intervention / Treatment: Behavioral: Treatment as Usual; Behavioral: Brief Prolonged Exposure Therapy

Detailed Description

This is a prospective randomized controlled trial examining the efficacy of brief Prolonged Exposure Therapy (Brief PE) delivered to individuals admitted to a Level I Trauma Center to reduce PTSD symptoms. The overall goal of this project is to test a Brief PE (three 60-minute sessions) to reduce psychological distress after injury and to mitigate long-term post-injury distress including PTSD as well as secondary health outcomes (including depression, general anxiety, pain, and quality of life) at 1, 3, and 6 months from baseline. The intervention group (Brief PE) will be compared to standard clinical care with treatment as usual (TAU).

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexis Evans, M.S; Phone Number: (214) 820-9918; Email: Alexis.Evans@BSWHealth.org
• Study Contact Backup: Name: Kamiah Moss, PhD; Email: Kamiah.Moss@BSWHealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor University Medical Center
      • Contact: Jessica Rostockyj; Phone Number: 254-749-5754; Email: jessica.rostockyj@bswhealth.org
      • Contact: Alexis Evans; Phone Number: 214-820-9918; Email: alexis.evans@bswhealth.org
      • Principal Investigator: Ann Marie Warren
    • Temple, Texas, United States, 76508
      • Recruiting
      • Baylor Scott & White Medical Center - Temple
      • Contact: Alexis Evans; Phone Number: 214-820-9918; Email: alexis.evans@bswhealth.org
      • Principal Investigator: Valerie Danesh
      • Contact: Valerie Danesh, PhD; Phone Number: 254-724-4719; Email: valerie.danesh@bswhealth.org
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert & Medical College of Wisconsin
      • Contact: Alexis Evans; Phone Number: 214-820-9918; Email: alexis.evans@bswhealth.org
      • Contact: Kelley Jazinski-Chambers; Phone Number: 414-350-8297; Email: kjazinski@mcw.edu
      • Principal Investigator: Terri deRoon-Cassini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between the ages of 18 and 75 years old.
• Admitted to Baylor University Medical Center at Dallas (BUMC), Baylor Scott & White Medical Center at Temple (BSWMC), or Froedtert Hospital and the Medical College of Wisconsin (FH/MCW) Level 1 Trauma Center

Exclusion Criteria:

• Patients in police custody
• Patients not fluent in English
• Patients with severe cognitive impairment
• Patients who are acutely suicidal
• Patients with active psychosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Treatment as Usual; Participants in the Treatment as Usual group (TAU) will not receive the Brief PE therapy, but the standard clinical treatment received by all patients admitted to BUMC, BSWMC Temple or FH/MCW trauma centers. Treatment as usual participants will have follow-up assessments at 1, 3, and 6 months from Baseline.	Behavioral: Treatment as Usual; Standard clinical treatment received by all patients admitted to BUMC, BSWMC Temple or FH/MCW trauma centers. At BUMC and FH/MCW, this may include an evaluation by a licensed psychologist or psychiatrist and continued follow-up psychotherapy and/or medication as needed. At BSWMC Temple this may include an evaluation by a licensed psychiatrist and follow up treatment as needed. In all locations this therapy does not consist of trauma-focused therapy and will be summarized in the analysis as a part of standard of care.
Experimental: Brief Prolonged Exposure; Participants in the experimental group will receive Brief Prolonged Exposure Therapy. In addition to the standard clinical treatment received by all patients at BUMC, BSWMC Temple and FH/MCW (treatment as usual), participants randomized to the intervention condition will also receive three 60-minute sessions of Brief PE. Participants in the BPE group will complete a screener and then questionnaires/interviews at 1, 2, and 6 months from Baseline.	Behavioral: Brief Prolonged Exposure Therapy; Brief PE will include 3 therapy sessions, each lasting approximately 60 minutes. The treatment is manualized and has been successfully implemented and evaluated in other challenging environments (i.e., Emergency Department. Trauma center). Brief PE includes education about common reactions to trauma, breathing retraining, prolonged (repeated) imaginal exposure to trauma memories, repeated in vivo/behavioral exposure to situations that participants are avoiding due to trauma-related fear, and discussion of thoughts and feelings related to exposure exercises. This discussion addresses patients' unrealistic beliefs about themselves and the world. In addition, patients are given homework to complete between each session (breathing practice, listening to the session recording, and completing behavioral exposures).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	The CAPS-5 is a 30-item, structured interview that assesses PTSD symptoms and makes a diagnostic determination based on the DSM-5 criteria and is considered the gold standard of PTSD assessment. Questions assess for PTSD symptoms corresponding to the 4 DSM-5 clusters of re-experiencing, avoidance, changes in mood and cognition, and arousal and hyperactivity, and includes questions on duration, impact of symptoms, distress and impact of symptoms on social and occupational functioning. The interviewer rates participant responses to symptom questions on a 5-point scale of frequency and severity, from 0 ("Absent") to 4 ("Extreme/incapacitating").	Baseline, 1-month, 3-month, 6-months
PTSD Checklist for DSM-5 (PCL-5)	The PCL-5 is a 20-item, self-report measure that assesses history of traumas and PTSD symptom severity over the last month according to the DSM-5 criteria.	Baseline, 1-month, 3-month, 6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a brief self-report measure of major depressive disorder. The PHQ-9 is a valid measure of depression for population-based studies and clinical populations with a cut off score of equal to or greater than 10 as the diagnostic for current depression.	Baseline, 1-month, 3-month, 6-months
The Generalized Anxiety Disorder 7-Item (GAD-7)	The GAD-7 is a 7-item questionnaire that measures severity of anxiety. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of 5, 10, and 15 representing mild, moderate, and severe anxiety symptom levels, respectively.	Baseline, 1-month, 3-month, 6-months
Brief Pain Inventory-Short Form (BPI-SF)	The BPI-SF has 9 items that measure the severity and impact of pain on daily function, with scores ranging from 0 (no pain and no interference) to 10 (pain as bad as one can imagine and complete interference) over the past 24 hours.	Baseline, 1-month, 3-month, 6-months
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)	Th3 Q-LES-Q-SF examines life satisfaction over the past week. The 16 items are rated on a 5-point scale from 1 "very poor" to 5 "very good" with scores from items added together and reported as a maximum possible score in percentage.	1-month, 3-month, 6-months

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: Medical College of Wisconsin; Froedtert Hospital
• Investigators: Principal Investigator: Ann Marie Warren, PhD, Baylor Scott & White Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Posttraumatic stress disorder; Traumatic injury
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Wounds and Injuries; Stress Disorders, Post-Traumatic; Therapeutics
• Other Study ID Numbers: 024-127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this study will be submitted to the National Institute of Mental Health (NIMH) Data Archive (NDA) at the National Institutes of Health (NIH). The NDA is a large database where de-identified study data from many NIH studies are stored and managed. Sharing your de-identified study data helps researchers learn new and important things about brain science more quickly than before. The following data will be submitted: Age, DSM-5 crosscutting assessment, PHQ-9, and the GAD-7.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No