Clinical trial NCT06210711: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Injury
PTSD
Posttraumatic Stress Disorder
Keywords: PTSD
Traumatic injury
Posttraumatic stress disorder
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Froedtert Hospital
name: Medical College of Wisconsin
First posted: 2024-01-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be allocated 1:1 into the Brief PE intervention or treatment as usual control group.
Primary purpose: 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.

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).

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

Primary outcomes:
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Baseline, 1-month, 3-month, 6-months
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline, 1-month, 3-month, 6-months
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 1-month, 3-month, 6-months
measure: The Generalized Anxiety Disorder 7-Item (GAD-7)
timeFrame: Baseline, 1-month, 3-month, 6-months
measure: Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: Baseline, 1-month, 3-month, 6-months
measure: Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
timeFrame: 1-month, 3-month, 6-months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple
state: Texas
city: Milwaukee
country: United States
facility: Froedtert & Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Baylor Scott & White Research Institute
name: Ann Marie Warren, PhD
role: PRINCIPAL_INVESTIGATOR
References: