Outcomes After Spinal Cord Injury (OASIS)

January 22, 2026 updated by: Baylor Research Institute

Prolonged Exposure Therapy (PE) for Posttraumatic Stress Disorder (PTSD) in Spinal Cord Injury (SCI): a Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The National Spinal Cord Injury Statistical Center estimates 282,000 people in the US live with spinal cord injury (SCI), with approximately 17,000 new cases occurring each year. There has been tremendous progress in the medical and rehabilitative management of people who have sustained SCI including improved clinical outcomes, decreased mortality during the first year after injury, and increased life expectancy. However, there has been less innovation to support mental health among SCI patients. In addition, most attention has been focused on addressing the elevated rate of depression in people with SCI. Much less attention has focused on Posttraumatic Stress Disorder (PTSD) despite prevalence estimates suggesting that it affects up to 60% of those with SCI compared to only 7% of the general US population. Notably, PTSD prevalence estimates among those with SCI are similar to those reported in a recent meta-analysis that showed 23% of veterans who served in conflicts in Afghanistan and Iraq experienced PTSD. PTSD can be a disabling psychological consequence of surviving SCI, impacting one's health and function, including the ability to return to normal activities of daily life (e.g., work, school, social relationships). Further, PTSD is one of the most costly of all anxiety disorders because of work impairment, hospitalization, and physician visits. Fortunately, there are highly effective treatments for PTSD. The most researched and effective treatment for PTSD is Prolonged Exposure Therapy. In 12 sessions over 6 weeks, 85% of patients with PTSD respond to treatment and the dropout rate is similar to all other treatments (20%). Thus far, PE has been tested within survivors of combat, rape, non-sexual assault, motor vehicle collisions, natural disasters, males/females, civilians/military, and adolescents. However, this treatment has not been tested with this population despite evidence that there is no reason to expect it would not be effective. In summary, greater attention has focused in recent years on PTSD and developing evidence-based approaches to treat it due to the number of veterans returning from conflicts in the Middle East dealing with the condition. Despite this increased overall focus on PTSD, and despite the higher prevalence of PTSD among people with SCI than among those in the general population, the literature lacks studies of PTSD in patients with SCI. Thus, the primary aim of the current study (Field Initiated Projects Program - Research HHS-2017-ACL-NIDILRR-IFRE-0192) is to use a randomized controlled trial (RCT) to evaluate the efficacy of Prolonged Exposure Therapy (PE) on PTSD symptoms among SCI patients. First, the investigators expect that individuals with SCI who receive the PE intervention for PTSD will show statistically significantly greater improvements in PTSD symptoms relative to the treatment as usual (TAU) control group. Second, the investigators hypothesize that compared to the TAU control group, those randomized to the PE will experience: a) significantly greater reduction in pain, b) significantly greater improvement in depression, c) significantly greater improvement in sleep, and d) significantly greater improvement in quality of life. Finally, we expect that PE will be feasible and acceptable in this population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Institute for Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Treatment as Usual
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
Experimental: 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.
Behavioral: Prolonged Exposure Therapy
Using a combination of In vivo and Imaginal exposure, Prolonged Exposure therapy aims to treat those with Posttraumatic Stress Disorder.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The PTSD Symptom Scale - Interview for DSM-5 (PSSI-5)
Time Frame: Used to assess change in Posttraumatic Stress entomology at Baseline, 6 week, 10 week, and 32 week about their past two week experiences.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The MINI International Neuropsychiatric Interview (MINI)
Time Frame: Assessed at Baseline about past month and lifetime experiences.
It assesses multiple diagnoses including Posttraumatic Stress Disorder, Major Depressive Depression, and Generalized Anxiety Disorder.
Assessed at Baseline about past month and lifetime experiences.
The Beck Depression Inventory-II (BDI-II)
Time Frame: Assessed at Baseline, at every Prolonged Therapy Session, 6 week, 10 week, and 32 week about their past month experiences.
The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.
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)
Time Frame: Assessed at Baseline, at every Prolonged Therapy Session, 6 week, 10 week, and 32 week about their past month experiences.
The Post-Traumatic Cognitions Inventory (PTCI) is a 36-item instrument that assesses dysfunctional post-trauma cognitions across self, world, and self-blame to yield a total score. The PCTI is rated on a Likert-type scale ranging from 1 (totally disagree) to 7 (totally agree)
Assessed at Baseline, at every Prolonged Therapy Session, 6 week, 10 week, and 32 week about their past month experiences.
Numerical Rating Scale (NRS)
Time Frame: Assessed at Baseline,10 week, and 32 week about their past week experience.
The Numerical Rating Scale (NRS) has been validated as a measure of pain intensity and is one of the most commonly used measures in assessing pain. The NRS asks patients to rate their pain severity on a 0 to 10 scale, with 0 being "no pain" to 10 being "so severe that you can't stand it."
Assessed at Baseline,10 week, and 32 week about their past week experience.
Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
Time Frame: Assessed at Baseline,10 week, and 32 week about their past month experience.
The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A), is a 7-item, self-report instrument that assesses the frequency of disruptive nocturnal behaviors, which are often associated with PTSD. Each item is rated on a 0-3 scale referring to frequency of each disturbance, where 0=not in the past month, 1=less than once a week, 2=once or twice a week, and 3=three or more times a week. A global score is obtained from the sum of all seven items, and has a range of 0-21. The PSQI-A includes three additional items regarding the frequency of anxiety and anger accompanying DNB and the timing of these events during the night.
Assessed at Baseline,10 week, and 32 week about their past month experience.
SCI Quality of Life- Positive Affect & Well-Being - Short Form (SCI-QOL)
Time Frame: Assessed at Baseline,10 week, and 32 week about their past week Past 7 Days experience.
SCI Quality of Life- Positive Affect & Well-Being - Short Form (SCI-QOL) is a 10- item, self-report measure that assesses participants' positive affect and well-being (e.g., "I thought positively about my future") in the past 7 days on a Likert scale of 1-5, with 1 representing "never" and 5 representing "always."
Assessed at Baseline,10 week, and 32 week about their past week Past 7 Days experience.
Posttraumatic Growth Inventory (PTGI)
Time Frame: Assessed at 32 week about their past week Past Month experience.
The Posttraumatic Growth Inventory (PTGI) is an instrument for assessing positive outcomes reported by persons who have experienced traumatic events. This 21-item scale includes factors of New Possibilities, Relating to Others, Personal Strength, Spiritual Change, and Appreciation of Life. A 6-point Likert response format was used, ranging from "I did not experience this change as a result of my crisis" (scored 0), to "I experienced this change to a very great degree as a result of my crisis" (scored 5). Intermediate scores were given for a very small degree (1), a small degree (2), a moderate degree (3), and a great degree (4).
Assessed at 32 week about their past week Past Month experience.
Alcohol Use Disorder Identification Test-Consumption (AUDIT-C)
Time Frame: Assessed at Baseline,10 week, and 32 week about their past week Past Year experience.
Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) is a 3-item alcohol screen that can identify problem alcohol use. The AUDIT-C is scored o a scale of 0-12, each question has 5 answer choices with "a" being 0 points and "e" being 4 points.
Assessed at Baseline,10 week, and 32 week about their past week Past Year experience.
Drug use
Time Frame: Assessed at Baseline,10 week, and 32 week about their past week Past Year experience.
Single Items and the Drug Abuse Screening Test (DAST) is used to assess the use of specific substances.
Assessed at Baseline,10 week, and 32 week about their past week Past Year experience.
Therapy history
Time Frame: Assessed at Baseline, 6 week, 10 week, and 32 week about their Recent experiences.
Therapy history is assessed via a 5-item face valid questionnaire made for the study. Questions ask about current and recent therapy and medication use in order to account for any outside therapy the TAU or PE participants might be getting using "yes" or "no" and open-ended responses.
Assessed at Baseline, 6 week, 10 week, and 32 week about their Recent experiences.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 017-410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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