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

February 9, 2026 updated by: Baylor Research Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White Medical Center - Temple
        • Contact:
        • Principal Investigator:
          • Valerie Danesh
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert & Medical College of Wisconsin
        • Contact:
        • Contact:
        • Principal Investigator:
          • Terri deRoon-Cassini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: Baseline, 1-month, 3-month, 6-months
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)
Time Frame: Baseline, 1-month, 3-month, 6-months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, 1-month, 3-month, 6-months
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)
Time Frame: Baseline, 1-month, 3-month, 6-months
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)
Time Frame: Baseline, 1-month, 3-month, 6-months
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)
Time Frame: 1-month, 3-month, 6-months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical College of Wisconsin
Froedtert Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ann Marie Warren, PhD, Baylor Scott & White Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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