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

PTSD Clinical Trial

Official title:

Prevention of Posttraumatic Stress: A Randomized Controlled Trial of Brief Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210711
• Other study ID #: 024-127
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: March 2027

Study information

• Verified date: January 2024
• Source: Baylor Research Institute
• Contact: Alexis Evans, M.S
• Phone: (214) 820-9918
• Email: Alexis.Evans[@]BSWHealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18 and 65 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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Injury
• Wounds and Injuries

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Baylor Research Institute	Froedtert Hospital, Medical College of Wisconsin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a brief self-report measure of major depressive disorder. The PHQ-9 is a valid measure of depression for population-based studies and clinical populations with a cut off score of equal to or greater than 10 as the diagnostic for current depression.	Baseline, 1-month, 3-month, 6-months
Secondary	The Generalized Anxiety Disorder 7-Item (GAD-7)	The GAD-7 is a 7-item questionnaire that measures severity of anxiety. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of 5, 10, and 15 representing mild, moderate, and severe anxiety symptom levels, respectively.	Baseline, 1-month, 3-month, 6-months
Secondary	Brief Pain Inventory-Short Form (BPI-SF)	The BPI-SF has 9 items that measure the severity and impact of pain on daily function, with scores ranging from 0 (no pain and no interference) to 10 (pain as bad as one can imagine and complete interference) over the past 24 hours.	Baseline, 1-month, 3-month, 6-months
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)	Th3 Q-LES-Q-SF examines life satisfaction over the past week. The 16 items are rated on a 5-point scale from 1 "very poor" to 5 "very good" with scores from items added together and reported as a maximum possible score in percentage.	1-month, 3-month, 6-months