Outcomes After Spinal Cord Injury (OASIS)



Status:Recruiting
Conditions:Hospital, Hospital, Orthopedic, Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:8/12/2018
Start Date:February 21, 2018
End Date:September 30, 2020
Contact:Jamie R Pogue, BA
Email:Jamie.Pogue@BSWHealth.org
Phone:2148652422

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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.

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.

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
We found this trial at
1
site
909 North Washington Avenue
Dallas, Texas 75246
?
mi
from
Dallas, TX
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