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

Not Applicable

Recruiting

• Conditions: Post-Traumatic Stress Disorder; Spinal Cord Injuries; PTSD
• Interventions: Behavioral: Brief Prolonged Exposure Therapy; Behavioral: Treatment as Usual

• Registration Number: NCT05233111
• Lead Sponsor: Baylor Research Institute

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 Timeline

• Status Verified: 2021-12
• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-31
• Study Start: 2022-02-07
• Study First Posted: 2022-02-10
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-03
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief Prolonged Exposure	Brief Prolonged Exposure Therapy	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.
Treatment as Usual	Treatment as Usual	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Baylor Institute for Rehabilitation; 🇺🇸 Dallas, Texas, United States