Prevention of Posttraumatic Stress: A RCT of Modified Brief Prolonged Exposure Therapy (Brief PE) During Inpatient Rehabilitation Post Spinal Cord Injury (SCI)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- Baylor Research Institute
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5
- Status
- Enrolling By Invitation
- Last Updated
- 3 months ago
Overview
Brief Summary
This study will examine the use brief prolonged exposure (Brief PE) therapy compared to standard clinical care to reduce posttraumatic distress among people who have had a spinal cord injury and are receiving rehabilitation in an inpatient setting.
Detailed Description
This is a prospective randomized controlled trial examining the efficacy of brief Prolonged Exposure Therapy (Brief PE) delivered in an inpatient rehabilitation setting post-SCI 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 SCI and to mitigate long-term post-SCI distress including PTSD as well as secondary health outcomes (including depression and general anxiety) 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years of age or older
- •Admitted to the inpatient rehabilitation hospital diagnosed with a SCI following a traumatic event
Exclusion Criteria
- •Patients in police custody
- •Not fluent in the English language
- •Severe cognitive impairment
- •Patients who are acutely suicidal
- •Patients with active psychosis
Outcomes
Primary Outcomes
Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5
Time Frame: Baseline, 1 month, 3 months ,6 months
Change in PTSD symptoms from baseline to 6 months. Total scale ranges from 0-80 points. Higher score indicates greater severity of symptoms.
Secondary Outcomes
- Change in Generalized Anxiety Disorder-7 Item(Time Frame: Baseline, 1 month, 3 months, 6 months)
- Change in Patient Health Questionnaire-9(Baseline, 1 month, 3 months ,6 months)