Prevention of Posttraumatic Stress: A RCT of Modified Brief Prolonged Exposure Therapy (Brief PE) During Inpatient Rehabilitation Post Spinal Cord Injury (SCI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Baylor Research Institute
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)