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

NCT06210711 · Baylor Research Institute
In plain English

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Official title
Prevention of Posttraumatic Stress: A Randomized Controlled Trial of Brief Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center
About this study
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).
Eligibility criteria
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
Enrollment target: 300 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-02-28
Estimated completion: 2027-09
Last updated: 2026-02-11
Interventions
Behavioral: Treatment as UsualBehavioral: Brief Prolonged Exposure Therapy
Primary outcomes
  • Clinician Administered PTSD Scale for DSM-5 (CAPS-5) (Baseline, 1-month, 3-month, 6-months)
  • PTSD Checklist for DSM-5 (PCL-5) (Baseline, 1-month, 3-month, 6-months)
Sponsor
Baylor Research Institute · other
With: Froedtert Hospital, Medical College of Wisconsin
Contacts & investigators
ContactAlexis Evans, M.S · contact · Alexis.Evans@BSWHealth.org · (214) 820-9918
ContactKamiah Moss, PhD · contact · Kamiah.Moss@BSWHealth.org
InvestigatorAnn Marie Warren, PhD · principal_investigator, Baylor Scott & White Research Institute
All locations (3)
Baylor University Medical CenterRecruiting
Dallas, Texas, United States
Baylor Scott & White Medical Center - TempleRecruiting
Temple, Texas, United States
Froedtert & Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center · TrialPath