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Enrolling by invitation NCT05233111

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

No phase Interventional Spinal Cord Injuries PTSD Post-Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brief Prolonged Exposure Therapy, Treatment as Usual.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries, PTSD, Post-Traumatic Stress Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5 [Time frame: Baseline, 1 month, 3 months ,6 months]
Secondary outcome measures (2)
  • Change in Patient Health Questionnaire-9 [Time frame: Baseline, 1 month, 3 months ,6 months]
  • Change in Generalized Anxiety Disorder-7 Item [Time frame: Time Frame: Baseline, 1 month, 3 months, 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Kirstie A Jones — Dallas

Identifiers

NCT: NCT05233111 · 021-339

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗