Recruiting

Prolonged Exposure Therapy

Sponsor:

Baylor Research Institute

Code:

NCT06210711

Conditions

Traumatic Injury

PTSD

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Treatment as Usual

Brief Prolonged Exposure Therapy

Study Details

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

Study ID

NCT06210711

Start date

Feb 28, 2024

Status verified date

Feb, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Principal Investigator:

Ann Marie Warren

Baylor Scott & White Medical Center - Temple

Recruiting

Temple, Texas, United States, 76508

Contacts

Principal Investigator:

Valerie Danesh

Froedtert & Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Principal Investigator:

Terri deRoon-Cassini

More Information

Sponsor

Baylor Research Institute

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • PTSD
  • Traumatic injury
  • Posttraumatic stress disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-02-11.