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
- PTSD
- Posttraumatic Stress Disorder
- Traumatic Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Treatment as Usual — BEHAVIORALStandard 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 — BEHAVIORALBrief 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 UsualParticipants 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 ExposureParticipants 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
- Alexis Evans, M.S(214) 820-9918
- Kamiah Moss, PhD
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Baylor University Medical Center | Dallas | Texas | 75246 | Ann Marie Warren (PRINCIPAL_INVESTIGATOR) |
| Baylor Scott & White Medical Center - Temple | Temple | Texas | 76508 | Valerie Danesh (PRINCIPAL_INVESTIGATOR) |
| Froedtert & Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Terri deRoon-Cassini (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Dallas, TX
By condition
By specialty
Related Studies
- Cervical Plexus Hydrodissection With D5W for PTSDRecruiting · Dr. Dean Reeves Clinic · Lexington, Kentucky
- Repurposing Low-Dose Clonidine for PTSD in VeteransPHASE3 · Recruiting · Wake Forest University Health Sciences · Wauwatosa, Wisconsin
- Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord InjuryEnrolling By Invitation · Baylor Research Institute · Dallas, Texas
- Neuromodulation of the Fear Extinction Circuit Using Temporally and Anatomically Specific TMS in HumansRecruiting · The University of Texas Health Science Center, Houston · Houston, Texas