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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT05233111
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 7, 2022
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Treatment as Usual
    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.
  • Experimental: Brief Prolonged Exposure
    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.

Primary Outcome Measure

Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5 [ Time Frame: Baseline, 1 month, 3 months ,6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Kirstie A JonesDallasTexas75204-

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