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

Not Applicable

Recruiting

• Conditions: Posttraumatic Stress Disorder; Traumatic Injury; PTSD
• Interventions: Behavioral: Treatment as Usual; Behavioral: Brief Prolonged Exposure Therapy

• Registration Number: NCT06210711
• Lead Sponsor: Baylor Research Institute

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-18
• Study Start: 2024-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2027-03
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as Usual	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.
Brief Prolonged Exposure	Brief Prolonged Exposure Therapy	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.

Primary Outcome Measures

Name	Time	Method
PTSD Checklist for DSM-5 (PCL-5)	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.
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	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").

Secondary Outcome Measures

Name	Time	Method
The Generalized Anxiety Disorder 7-Item (GAD-7)	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.
Patient Health Questionnaire (PHQ-9)	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.
Brief Pain Inventory-Short Form (BPI-SF)	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.
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)	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.

Trial Locations

Locations (3)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

Baylor Scott & White Medical Center - Temple; 🇺🇸 Temple, Texas, United States

Froedtert & Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States