Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be allocated 1:1 into the Brief PE intervention or treatment as usual control group.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
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.
  • 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 part of standard of care.
Experimental
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.
  • 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 discussion of thoughts and feelings related to exposure exercises. This discussion addresses patients' unrealistic beliefs about themselves and the world. In addition, patients are given homework to complete between each session (breathing practice, listening to the session recording, and completing behavioral exposures).

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Baylor Research Institute

Study Contact

Alexis Evans, M.S
(214) 820-9918
Alexis.Evans@BSWHealth.org

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.