Prevention of Posttraumatic Stress: A Randomized Controlled Trial of Brief Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Baylor Research Institute
- Enrollment
- 300
- Locations
- 3
- Primary Endpoint
- PTSD Checklist for DSM-5 (PCL-5)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Treatment as Usual (Behavioral)
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.
Intervention: Brief Prolonged Exposure Therapy (Behavioral)
Outcomes
Primary Outcomes
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.
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").
Secondary Outcomes
- The Generalized Anxiety Disorder 7-Item (GAD-7)(Baseline, 1-month, 3-month, 6-months)
- Patient Health Questionnaire (PHQ-9)(Baseline, 1-month, 3-month, 6-months)
- Brief Pain Inventory-Short Form (BPI-SF)(Baseline, 1-month, 3-month, 6-months)
- Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)(1-month, 3-month, 6-months)