Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment as Usual, Brief Prolonged Exposure Therapy.
- Who it may be relevant to
- Registry conditions: Traumatic Injury, PTSD, Posttraumatic Stress Disorder. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- 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 par - 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 dis
Primary outcome measures
- Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [Time frame: Baseline, 1-month, 3-month, 6-months]
- PTSD Checklist for DSM-5 (PCL-5) [Time frame: Baseline, 1-month, 3-month, 6-months]
Secondary outcome measures (4)
- Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, 1-month, 3-month, 6-months]
- The Generalized Anxiety Disorder 7-Item (GAD-7) [Time frame: Baseline, 1-month, 3-month, 6-months]
- Brief Pain Inventory-Short Form (BPI-SF) [Time frame: 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Baylor University Medical Center — Dallas
- Baylor Scott & White Medical Center - Temple — Temple
- Froedtert & Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT06210711 · 024-127