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

N/AEnrolling By InvitationNCT05233111

Baylor Research Institute200 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Spinal Cord Injuries PTSD Post-Traumatic Stress Disorder

Interventions

Brief Prolonged Exposure TherapyBEHAVIORAL

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

Treatment as UsualBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Kirstie A Jones

Dallas, Texas, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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