Outcomes After Spinal Cord Injury (OASIS)

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Posttraumatic Stress Disorder; Spinal Cord Injuries

Treatments: Behavioral: Prolonged Exposure Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03624218

017-410

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Treatment as Usual

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Prolonged Exposure Therapy