Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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).

Official Title
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Prevention of Posttraumatic Stress: A RCT of Modified Brief Prolonged Exposure Therapy (Brief PE) During Inpatient Rehabilitation Post Spinal Cord Injury (SCI)

Conditions
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Spinal Cord Injuries, PTSD, Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Brief Prolonged Exposure Therapy
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Treatment as Usual<br>Participants 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. | Behavioral: Treatment as Usual<br>* 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.<br>|
| Experimental: Brief Prolonged Exposure<br>Experimental: 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. | Behavioral: Brief Prolonged Exposure Therapy<br>* Brief PE will include 3 therapy sessions, each lasting approximately 60 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5 | Change in PTSD symptoms from baseline to 6 months. Total scale ranges from 0-80 points. Higher score indicates greater severity of symptoms. | Baseline, 1 month, 3 months ,6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire-9 | Change in depressed mood from baseline to 6 months. Scored on a 0-27 scale. Higher score indicates greater severity of issues. | Baseline, 1 month, 3 months ,6 months | 
| Change in Generalized Anxiety Disorder-7 Item | Change in anxiety scored using a 0-21 scale. Higher score indicates greater anxiety. | Time Frame: Baseline, 1 month, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, SCI, Spinal Cord Injury, Post-Traumatic Stress Disorder