Outcomes After Spinal Cord Injury (OASIS)

NCT03624218 | Completed

• 1 other identifier: 017-410
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the effectiveness of Prolonged Exposure Therapy on a population of individuals with spinal cord injuries. Participants will be randomly assigned to either a treatment as usual or Prolonged Exposure therapy group.

Conditions

Posttraumatic Stress Disorder; Spinal Cord Injuries

Keywords

PTSD; SCI; PE; Prolonged Exposure

Outcome Measures

Primary Outcomes (1)

• The PTSD Symptom Scale - Interview for DSM-5 (PSSI-5)

  The PSSI-5 is a 24-item, semi-structured interview that assesses PTSD symptoms in the past two weeks, and makes a diagnostic determination based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria. The interviewer rates participant responses to symptom questions on a 5-point scale of frequency and severity, from 0 ("Not at all") to 4 ("6 or more times a week/severe") with a higher total score meaning more Posttraumatic stress symptoms.

  Used to assess change in Posttraumatic Stress entomology at Baseline, 6 week, 10 week, and 32 week about their past two week experiences.

Secondary Outcomes (10)

• The MINI International Neuropsychiatric Interview (MINI)

  Assessed at Baseline about past month and lifetime experiences.

• The Beck Depression Inventory-II (BDI-II)

  Assessed at Baseline, at every Prolonged Therapy Session, 6 week, 10 week, and 32 week about their past month experiences.

• Post-Traumatic Cognitions Inventory (PTCI)

  Assessed at Baseline, at every Prolonged Therapy Session, 6 week, 10 week, and 32 week about their past month experiences.

• Numerical Rating Scale (NRS)

  Assessed at Baseline,10 week, and 32 week about their past week experience.

• Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)

  Assessed at Baseline,10 week, and 32 week about their past month experience.

Study Arms (2)

Treatment as Usual

NO 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

Intervention

EXPERIMENTAL

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.

Behavioral: Prolonged Exposure Therapy

Interventions

Prolonged Exposure Therapy BEHAVIORAL

Using a combination of In vivo and Imaginal exposure, Prolonged Exposure therapy aims to treat those with Posttraumatic Stress Disorder.

Intervention

Eligibility Criteria

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

You may qualify if:

• Patients admitted to the trauma service at BUMC or Inpatient service at BIR
• Patients with SCI
• Patients at least 30 days post injury (to insure proper PTSD diagnosis)
• Patients ages 18 and older
• Patients who have a positive PTSD screen using PTSD Symptom Scale - Interview for DSM-5 (PSSI-5)

You may not qualify if:

• Patients in police custody
• Non-English speaking
• Patients with severe cognitive impairment (will be assessed through chart review and with the Cognistat)
• Patients who are acutely suicidal and/or have been admitted for a suicide attempt
• Patients who are actively psychotic

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, 75246, United States

Location

Related Publications (1)

• Douglas ME, Bennett M, Jones KA, Pogue JR, Chauvette GV, Sikka S, Driver S, Hamilton R, Curcio N, Patel S, Wierzchowski A, Adams M, Thomas EV, Turner E, Leonard K, Carl E, Foreman M, Warren AM, Powers MB. Prolonged exposure for posttraumatic stress disorder following spinal cord injury: A randomized controlled trial. Rehabil Psychol. 2025 Aug;70(3):240-254. doi: 10.1037/rep0000580. Epub 2024 Aug 29.

  PMID: 39207423 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

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: July 25, 2018
• First Posted: August 10, 2018
• Study Start: February 21, 2018
• Primary Completion: March 30, 2021
• Study Completion: January 6, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)