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Enrolling by Invitation

NCT Number: NCT05233111

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Mental Disorders Nervous System Diseases PTSD Post-traumatic Stress Disorder Spinal Cord Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kirstie A Jones

Dallas, Texas, 75204, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Prolonged Exposure Therapy

Behavioral

Brief PE will include 3 therapy sessions, each lasting approximately 60 minutes.

Treatment as Usual

Behavioral

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.

Primary outcomes

  1. Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5

    Time frame: 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 outcomes

  1. Change in Patient Health Questionnaire-9

    Time frame: 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.

  2. Change in Generalized Anxiety Disorder-7 Item

    Time frame: Time Frame: Baseline, 1 month, 3 months, 6 months

    Change in anxiety scored using a 0-21 scale. Higher score indicates greater anxiety.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2022
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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