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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05233111
• Other study ID #: 021-339
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: August 2026

Study information

• Verified date: December 2021
• Source: Baylor Research Institute
• Contact: Neil M Stewart
• Phone: 2148205843
• Email: neil.stewart[@]bswhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• PTSD
• Spinal Cord Injuries
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Wounds and Injuries

Intervention

Behavioral:
• Brief Prolonged Exposure Therapy
Brief PE will include 3 therapy sessions, each lasting approximately 60 minutes.
• Treatment 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.

Locations

Country	Name	City	State
United States	Baylor Institute for Rehabilitation	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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