Abstract
Objective
The main purpose of the trial was to test if a brief trauma focused cognitive-behavior therapy (prolonged exposure; PE) provided within 72h after a trauma could be effective in decreasing the incidence of post-traumatic stress disorder (PTSD), replicating and extending findings from an earlier trial. After a pilot study (N=10), which indicated feasible and deliverable study procedures and interventions, we subsequently launched an RCT with a target sample size of 352 participants randomized to either three sessions PE or non-directive support. Due to an unforeseen major reorganization at the hospital, the RCT was discontinued after 32 included participants.
Results
In this paper, we highlight obstacles and lessons learned from our feasibility work, relevant for preventive psychological interventions for PTSD in emergency settings. One important finding was the high degree of attrition: only 78% and 34% respectively came back for the two months and six-months assessments. There were also difficulties in reaching eligible patients immediately after the event. Based on our experiences, we envisage that alternative models of implementation might overcome these obstacles, for example, with remote delivery of both assessments and treatment, combined with multiple recruitment procedures. Lessons learned from this terminated RCT are discussed in depth.