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Prolonged Exposure Therapy for PTSD After Spinal Cord Injury

N/A
Recruiting
Led By Mark B Powers, PhD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Admitted to the inpatient rehabilitation hospital diagnosed with a SCI following a traumatic event
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months ,6 months
Awards & highlights

Summary

This trial will compare the effects of a common therapy for PTSD against a more intensive exposure-based therapy for people with spinal cord injuries receiving inpatient rehabilitation.

Who is the study for?
This trial is for adults over 18 who have experienced a traumatic spinal cord injury and are currently in an inpatient rehabilitation hospital. It's designed to help those struggling with posttraumatic stress as a result of their injury.
What is being tested?
The study is testing Brief Prolonged Exposure (Brief PE) therapy against the standard treatment typically given for posttraumatic stress in patients with spinal cord injuries during their rehab stay.
What are the potential side effects?
While not explicitly stated, side effects may include temporary increases in distress due to recalling traumatic events, which is common with exposure therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am in rehab for a spinal cord injury from an accident.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months ,6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months ,6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5
Secondary study objectives
Change in Generalized Anxiety Disorder-7 Item
Change in Patient Health Questionnaire-9

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Brief Prolonged ExposureExperimental Treatment1 Intervention
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.
Group II: Treatment as UsualPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
205 Previous Clinical Trials
203,215 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
77 Previous Clinical Trials
9,451 Total Patients Enrolled
Mark B Powers, PhDPrincipal InvestigatorBaylor Scott and White Research Institute-Trauma

Media Library

Brief Prolonged Exposure Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05233111 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Treatment as Usual, Brief Prolonged Exposure
Post-Traumatic Stress Disorder Clinical Trial 2023: Brief Prolonged Exposure Therapy Highlights & Side Effects. Trial Name: NCT05233111 — N/A
Brief Prolonged Exposure Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05233111 — N/A
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05233111 — N/A
~83 spots leftby Aug 2026
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