Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Part of paid clinical trials in Dallas, Texas.
- Sponsor
- Baylor Research Institute
- Study ID
- NCT05233111
- Status
- Enrolling By Invitation
Conditions
- PTSD
- Post-Traumatic Stress Disorder
- Spinal Cord Injuries
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Brief Prolonged Exposure Therapy — BEHAVIORALBrief PE will include 3 therapy sessions, each lasting approximately 60 minutes.
- Treatment as Usual — BEHAVIORALThis may include an evaluation by a licensed psychologist and continued follow-up psychotherapy as needed. Treatment as usual participants will have follow-up assessments at 1, 3, and 6 months.
Study Details
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.
Key Dates
- Start date
- Feb 7, 2022
- Status verified
- Jan 2026
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Treatment as UsualParticipants in the Treatment as Usual (TAU) group will not receive Prolonged Exposure therapy, but will instead receive the standard clinical treatment received by all persons with spinal cord injury (SCI) at the rehabilitation facility. TAU participants will complete questionnaires/interviews at 1, 3, and 6 months from Baseline.
- Experimental: Brief Prolonged ExposureExperimental: Brief Prolonged Exposure Participants will receive Brief PE. Subjects in the Brief Prolonged Exposure (BPE) intervention group will additionally receive 3 total therapy sessions, each lasting about 60 minutes spaced about 1-7 days apart. Sessions include education about common reactions to trauma, breathing retraining, identification of self-care tasks and prolonged (repeated) imaginal exposure to trauma memories. Any missed sessions will be made up by scheduling multiple sessions in subsequent weeks. Individuals in the BPE group will complete a screener and then survey questionnaires/ interviews at 1, 3, and 6 months from Baseline.
Primary Outcome Measure
Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5 [ Time Frame: Baseline, 1 month, 3 months ,6 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Kirstie A Jones | Dallas | Texas | 75204 | - |
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