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

Baylor Scott and White Health (BSWH)

Status: Enrolling

Conditions: Posttraumatic Stress Disorder; PTSD; Traumatic Injury

Treatments: Behavioral: Brief Prolonged Exposure Therapy; Behavioral: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT06210711

024-127

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups, including a placebo group

Treatment as Usual

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Treatment as Usual

Brief Prolonged Exposure

Experimental group

Description:

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.

Treatment:

Behavioral: Brief Prolonged Exposure Therapy