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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT06210711
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Treatment as Usual — BEHAVIORAL
    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.
  • Brief Prolonged Exposure Therapy — BEHAVIORAL
    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).

Study Details

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.

Key Dates

Start date
Feb 28, 2024
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Baseline, 1-month, 3-month, 6-months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Baylor University Medical CenterDallasTexas75246
Jessica Rostockyj
254-749-5754
Alexis Evans
214-820-9918
Ann Marie Warren (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White Medical Center - TempleTempleTexas76508
Valerie Danesh, PhD
254-724-4719
Alexis Evans
214-820-9918
Valerie Danesh (PRINCIPAL_INVESTIGATOR)
Froedtert & Medical College of WisconsinMilwaukeeWisconsin53226
Kelley Jazinski-Chambers
414-350-8297
Alexis Evans
214-820-9918
Terri deRoon-Cassini (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

Related Studies