Posttraumatic Stress DisorderNCT03624218
Outcomes After Spinal Cord Injury (OASIS)
A study testing Prolonged Exposure Therapy in people with Posttraumatic Stress Disorder and Spinal Cord Injuries, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Spinal Cord Injuries
- What is being tested?
- Prolonged Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2018to 6 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Institute for Rehabilitation
Dallas, Texas, 75246
About this study
Official title: 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.
Read the 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.
- Being tested
- Prolonged Exposure Therapy
- Keywords
- PTSD, SCI, PE, Prolonged Exposure
- Medical subject headings
- Stress Disorders, Post-Traumatic, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure TherapyBehavioural
Using a combination of In vivo and Imaginal exposure, Prolonged Exposure therapy aims to treat those with Posttraumatic Stress Disorder.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Prolonged Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
It assesses multiple diagnoses including Posttraumatic Stress Disorder, Major Depressive Depression, and Generalized Anxiety Disorder.
Measured: Assessed at Baseline about past month and lifetime experiences.
The Beck Depression Inventory-II (BDI-II)
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.
Measured: 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)
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)
Measured: Assessed at Baseline, at every Prolonged Therapy Session, 6 week, 10 week, and 32 week about their past month experiences.
Numerical Rating Scale (NRS)
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."
Measured: Assessed at Baseline,10 week, and 32 week about their past week experience.
Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
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.
Measured: 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)
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."
Measured: Assessed at Baseline,10 week, and 32 week about their past week Past 7 Days experience.
Posttraumatic Growth Inventory (PTGI)
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).
Measured: Assessed at 32 week about their past week Past Month experience.
Alcohol Use Disorder Identification Test-Consumption (AUDIT-C)
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.
Measured: Assessed at Baseline,10 week, and 32 week about their past week Past Year experience.
Drug use
Single Items and the Drug Abuse Screening Test (DAST) is used to assess the use of specific substances.
Measured: Assessed at Baseline,10 week, and 32 week about their past week Past Year experience.
Therapy history
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.
Measured: Assessed at Baseline, 6 week, 10 week, and 32 week about their Recent experiences.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start21 Feb 2018
- Primary completion30 Mar 2021
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624218
- Sponsor's protocol ID
- 017-410
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2018
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39207423
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Exposure Therapy (PE) for Posttraumatic Stress Disorder (PTSD) in Spinal Cord Injury (SCI): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03624218
- Acronym / sponsor ID
- 017-410
- Keywords
- PTSD, SCI, PE, Prolonged Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Prolonged Exposure TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure TherapyUsing a combination of In vivo and Imaginal exposure, Prolonged Exposure therapy aims to treat those with Posttraumatic Stress Disorder. | Behavioural | Intervention |
Primary outcome
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.
10 secondary outcomes
The MINI International Neuropsychiatric Interview (MINI)
Time frame: 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.
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.
Numerical Rating Scale (NRS)
Time frame: 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.
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.
Posttraumatic Growth Inventory (PTGI)
Time frame: 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.
Drug use
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 39207423Douglas 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure Therapy in people with Posttraumatic Stress Disorder and Spinal Cord Injuries, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.