Post-Traumatic Stress Disorder, PTSD, Spinal Cord Injuries
Conditions
Keywords
PTSD, SCI, Spinal Cord Injury, Post-Traumatic Stress Disorder
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).
Interventions
BEHAVIORALBrief Prolonged Exposure Therapy
Brief PE will include 3 therapy sessions, each lasting approximately 60 minutes.
BEHAVIORALTreatment as Usual
This 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.
Sponsors
Baylor Research Institute
National Institute on Disability, Independent Living, and Rehabilitation Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire-9 | Baseline, 1 month, 3 months ,6 months | Change in depressed mood from baseline to 6 months. Scored on a 0-27 scale. Higher score indicates greater severity of issues. |
| Change in Generalized Anxiety Disorder-7 Item | Time Frame: Baseline, 1 month, 3 months, 6 months | Change in anxiety scored using a 0-21 scale. Higher score indicates greater anxiety. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark B Powers, PhD
Baylor Scott and White Research Institute-Trauma
Outcome results
None listed