Prolonged exposure therapy for PTSD among spinal cord injury survivors: Study protocol for a randomized controlled trial

Abstract

The National Spinal Cord Injury Statistical Center estimates 294,000 people in the US live with a spinal cord injury (SCI), with approximately 17,810 new cases each year. Although the physical outcomes associated with SCI have been widely studied, the psychological consequences of sustaining a SCI remain largely unexplored. Scant research has focused on posttraumatic stress disorder (PTSD) in this population, despite prevalence estimates suggesting that up to 60% of individuals with SCI experience PTSD post-injury, compared to only 7% of the general US population. Fortunately, prolonged exposure therapy (PE) is a well-researched and highly effective treatment for PTSD. However, no trauma focused exposure-based therapy for PTSD (e.g. PE) has not yet been tested in a SCI population. Thus, we aim to conduct the first test of an evidence-based intervention for PTSD among patients with SCI. Adults with SCI and PTSD ( N = 60) will be randomly assigned to either: (1) 12-sessions of PE (2–3 sessions per week) or (2) a treatment as usual (TAU) control group who will receive the standard inpatient rehabilitation care for SCI patients. Primary outcomes will be assessed at 0, 6, 10, and 32 weeks.

Prevention of posttraumatic stress during inpatient rehabilitation post spinal cord injury: Study protocol for a randomized controlled trial of Brief Prolonged Exposure Therapy (Brief PE)

“…1 ). The improvement in symptoms was similar in magnitude to that seen in other trauma populations [ 40 ] and showed that this treatment approach is feasible in the inpatient rehabilitation setting [ 41 ]. Although feasible, we found that the standard 12-session PE treatment was difficult due to the nature of the inpatient rehabilitation setting, primarily the demanding schedule of physical, occupational, and other rehabilitative therapies.…”

“…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”). This measure has been used in our ongoing studies [ 41 , [67] , [68] , [69] , [70] ] and will be conducted by a trained independent evaluator.…”

“…To detect a difference between groups on the primary outcome (PSSI-5) with 80% power at 5% significance, we would need to enroll 80 participants per group or 160 participants total. We anticipate a 20% attrition rate based on our previous PE intervention work with this population [ 41 ], therefore, we will plan to enroll 200 total participants, with 100 in each group, during the study period.…”

“…Fortunately, highly effective treatments for PTSD exist and within the general population, the most researched and highly effective treatment for PTSD is prolonged exposure therapy (PE). [ [36] , [37] , [38] , [39] ] Previous research demonstrated that in 12 (90-min) sessions over a 6-week period, 85% of patients with PTSD respond to treatment with the dropout rate similar to other non-exposure-based treatments (20%).40 Based on this evidence, we conducted the first and only randomized controlled to date of PE for individuals with SCI who were diagnosed with PTSD [ 41 ].…”