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Behavioral Intervention

Intervention for Spinal Cord Injury

N/A
Waitlist Available
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline,10 week, and 32 week about their past month experience.
Awards & highlights

Study Summary

This study is evaluating whether prolonged exposure therapy may help individuals with spinal cord injuries.

Eligible Conditions
  • Spinal Cord Injury
  • Post-Traumatic Stress Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, at every prolonged therapy session, 6 week, 10 week, and 32 week about their past month experiences.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, at every prolonged therapy session, 6 week, 10 week, and 32 week about their past month experiences. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The PTSD Symptom Scale - Interview for DSM-5 (PSSI-5)
Secondary outcome measures
Alcohol Use Disorder Identification Test-Consumption (AUDIT-C)
Drug use
Numerical Rating Scale (NRS)
+7 more

Side effects data

From 2017 Phase 4 trial • 223 Patients • NCT01524133
49%
Gastrointestinal
35%
Psychological
32%
Neurological
25%
Genitourinary
14%
Respiratory
13%
Muskuloskeletal
4%
Increased Suicidal Ideation
3%
Cardiovascular
1%
dyspepsia
1%
Endocrine
1%
Dermatological
1%
Increased Irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prolonged Exposure + Sertraline (PE/SERT)
Sertraline + Enhanced Medication Management (SERT/EMM)
Prolonged Exposure + Placebo (PE/PLB)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants randomized to the PE intervention will receive 2-3, 60-minute sessions each week for 4-6 weeks (12 total sessions). Treatment is manualized, and includes education about common reactions to trauma, breathing retraining, prolonged (repeated) imaginal exposure to trauma memories, repeated in vivo exposure to situations that participants are avoiding due to trauma-related fear, and discussion of thoughts and feelings related to exposure exercises.
Group II: Treatment as UsualActive Control1 Intervention
Participants in the control arm will not receive the PE therapy, but they will rather receive the standard clinical treatment receive by all SCI patients at BIR. This includes an evaluation by a licensed psychologist and continued follow-up psychotherapy as needed. This therapy does not consist of trauma-focused therapy and will be summarized in the analysis as a part of standard of care. TAU participants will have a posttreatment assessment, as well as follow-up assessments at one and 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prolonged Exposure Therapy
2008
Completed Phase 4
~860

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
200 Previous Clinical Trials
203,196 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Outcomes After Spinal Cord Injury (OASIS)
2018. "Outcomes After Spinal Cord Injury (OASIS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03624218.
All > Spinal Cord
~4 spots leftby Apr 2025
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