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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neil M Stewart; Phone Number: 2148205843; Email: neil.stewart@bswhealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75204
      • Recruiting
      • Baylor Institute for Rehabilitation
      • Contact: Neil Stewart; Phone Number: 214-820-5843; Email: neil.stewart@bswhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Behavioral: 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.
Experimental: Brief Prolonged Exposure; 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; Brief PE will include 3 therapy sessions, each lasting approximately 60 minutes.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
• Investigators: Principal Investigator: Mark B Powers, PhD, Baylor Scott and White Research Institute-Trauma

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Anticipated): August 1, 2026
• Study Completion (Anticipated): August 1, 2026

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: PTSD; Spinal Cord Injury; SCI; Post-Traumatic Stress Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Trauma and Stressor Related Disorders; Spinal Cord Diseases; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 021-339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No