Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBaylor Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients in police custody
Patients not fluent in English
Patients with severe cognitive impairment
Patients who are acutely suicidal
Trial design
Design model
Parallel
Treatments tested in this trial
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).
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Treatment as UsualPlacebo comparator 1 intervention
Group B: Brief Prolonged ExposureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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").
Time frame
Baseline, 1-month, 3-month, 6-months2
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.
Time frame
Baseline, 1-month, 3-month, 6-monthsSecondary outcomes
1
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.
Time frame
Baseline, 1-month, 3-month, 6-months2
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.
Time frame
Baseline, 1-month, 3-month, 6-months3
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.
Time frame
Baseline, 1-month, 3-month, 6-months4
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.
Time frame
1-month, 3-month, 6-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Baylor Research Institute
Lead sponsor
Froedtert Hospital
Collaborator
Medical College of Wisconsin
Collaborator
Source ClinicalTrials.gov