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Studies

Interventional Recruiting

NCT06210711 on ClinicalTrials.gov

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

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

  • Sponsor: Baylor Scott & White Research Institute
  • Collaborators: Froedtert Hospital, Medical College of Wisconsin
  • Enrollment: 300 (Estimated)
  • Study start: 2024-02-28 (Actual)
  • Primary completion: 2027-03-01 (Estimated)
  • Study completion: 2027-09-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Participants will be allocated 1:1 into the Brief PE intervention or treatment as usual control group.
  • Masking: None
  • PrimaryPurpose: Treatment

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.

Conditions

  • Traumatic Injury
  • PTSD
  • Posttraumatic Stress Disorder

Intervention / Treatment

  • Behavioral: Treatment as Usual
  • Behavioral: Brief Prolonged Exposure Therapy

Primary Outcome Measures

  • 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").
  • 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.

Countries

United States

Locations and Investigators

  • Baylor University Medical Center, Dallas, United States (Recruiting)
    • Roxane Gonod
    • Alexis Evans
    • Ann Marie Warren (Principal Investigator)
  • Baylor Scott & White Medical Center - Temple, Temple, United States (Recruiting)
    • Valerie Danesh, PhD
    • Alexis Evans
    • Valerie Danesh (Principal Investigator)
  • Froedtert & Medical College of Wisconsin, Milwaukee, United States (Recruiting)
    • Kelley Jazinski-Chambers
    • Alexis Evans
    • Terri deRoon-Cassini (Principal Investigator)

Study Officials