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

NCT05233111 | Enrolling By Invitation

• 1 other identifier: 021-339
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; PTSD; Post-Traumatic Stress Disorder

Keywords

PTSD; SCI; Spinal Cord Injury; Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Patient Health Questionnaire-9

  Baseline, 1 month, 3 months ,6 months

• Change in Generalized Anxiety Disorder-7 Item

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

Study Arms (2)

Treatment as Usual

PLACEBO COMPARATOR

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

Brief Prolonged Exposure

EXPERIMENTAL

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

Interventions

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.

Treatment as Usual

Brief Prolonged Exposure Therapy BEHAVIORAL

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

Brief Prolonged Exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Admitted to the inpatient rehabilitation hospital diagnosed with a SCI following a traumatic event

You may not qualify if:

• Patients in police custody
• Not fluent in the English language
• Severe cognitive impairment
• Patients who are acutely suicidal
• Patients with active psychosis

Sponsors & Collaborators

• Baylor Research Institute: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Kirstie A Jones

Dallas, Texas, 75204, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Mark B Powers, PhD

  Baylor Scott and White Research Institute-Trauma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 10, 2022
• Study Start: February 7, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)