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

NCT06210711 | Recruiting DMC

• 1 other identifier: 024-127
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Traumatic Injury; PTSD; Posttraumatic Stress Disorder

Keywords

PTSD; Traumatic injury; Posttraumatic stress disorder

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

  The CAPS-5 is a 30-item, structured interview that assesses PTSD symptoms and makes a diagnostic determination based on the DSM-5 criteria and is considered the gold standard of PTSD assessment. Questions assess for PTSD symptoms corresponding to the 4 DSM-5 clusters of re-experiencing, avoidance, changes in mood and cognition, and arousal and hyperactivity, and includes questions on duration, impact of symptoms, distress and impact of symptoms on social and occupational functioning. The interviewer rates participant responses to symptom questions on a 5-point scale of frequency and severity, from 0 ("Absent") to 4 ("Extreme/incapacitating").

  Baseline, 1-month, 3-month, 6-months

• PTSD Checklist for DSM-5 (PCL-5)

  The PCL-5 is a 20-item, self-report measure that assesses history of traumas and PTSD symptom severity over the last month according to the DSM-5 criteria.

  Baseline, 1-month, 3-month, 6-months

Secondary Outcomes (4)

• Patient Health Questionnaire (PHQ-9)

  Baseline, 1-month, 3-month, 6-months

• The Generalized Anxiety Disorder 7-Item (GAD-7)

  Baseline, 1-month, 3-month, 6-months

• Brief Pain Inventory-Short Form (BPI-SF)

  Baseline, 1-month, 3-month, 6-months

• Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)

  1-month, 3-month, 6-months

Study Arms (2)

Treatment as Usual

PLACEBO COMPARATOR

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

Brief Prolonged Exposure

EXPERIMENTAL

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

Interventions

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).

Brief Prolonged Exposure

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.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients in police custody
• Patients not fluent in English
• Patients with severe cognitive impairment
• Patients who are acutely suicidal
• Patients with active psychosis

Sponsors & Collaborators

• Baylor Research Institute: lead
• Froedtert Hospital: collaborator
• Medical College of Wisconsin: collaborator

Study Sites (3)

Baylor University Medical Center

Dallas, Texas, 75246, United States

RECRUITING

Baylor Scott & White Medical Center - Temple

Temple, Texas, 76508, United States

RECRUITING

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Ann Marie Warren, PhD

  Baylor Scott & White Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis Evans, M.S

CONTACT

(214) 820-9918; Alexis.Evans@BSWHealth.org

Kamiah Moss, PhD

CONTACT

Kamiah.Moss@BSWHealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be allocated 1:1 into the Brief PE intervention or treatment as usual control group.

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: February 28, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (3)