Clinical trial NCT03624218: Outcomes After Spinal Cord Injury (OASIS)
Official title: Prolonged Exposure Therapy (PE) for Posttraumatic Stress Disorder (PTSD) in Spinal Cord Injury (SCI): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posttraumatic Stress Disorder
Spinal Cord Injuries
Keywords: PTSD
SCI
PE
Prolonged Exposure
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The PTSD Symptom Scale - Interview for DSM-5 (PSSI-5)
timeFrame: 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:
measure: The MINI International Neuropsychiatric Interview (MINI)
timeFrame: Assessed at Baseline about past month and lifetime experiences.
measure: The Beck Depression Inventory-II (BDI-II)
timeFrame: Assessed at Baseline, at every Prolonged Therapy Session, 6 week, 10 week, and 32 week about their past month experiences.
measure: Post-Traumatic Cognitions Inventory (PTCI)
timeFrame: Assessed at Baseline, at every Prolonged Therapy Session, 6 week, 10 week, and 32 week about their past month experiences.
measure: Numerical Rating Scale (NRS)
timeFrame: Assessed at Baseline,10 week, and 32 week about their past week experience.
measure: Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
timeFrame: Assessed at Baseline,10 week, and 32 week about their past month experience.
measure: SCI Quality of Life- Positive Affect & Well-Being - Short Form (SCI-QOL)
timeFrame: Assessed at Baseline,10 week, and 32 week about their past week Past 7 Days experience.
measure: Posttraumatic Growth Inventory (PTGI)
timeFrame: Assessed at 32 week about their past week Past Month experience.
measure: Alcohol Use Disorder Identification Test-Consumption (AUDIT-C)
timeFrame: Assessed at Baseline,10 week, and 32 week about their past week Past Year experience.
measure: Drug use
timeFrame: Assessed at Baseline,10 week, and 32 week about their past week Past Year experience.
measure: Therapy history
timeFrame: Assessed at Baseline, 6 week, 10 week, and 32 week about their Recent experiences.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Institute for Rehabilitation
state: Texas
Study officials:
References: