Massed versus standard prolonged exposure for posttraumatic stress disorder in Australian military and veteran populations (RESTORE trial): Study protocol for a non-inferiority randomized controlled trial.

Posttraumatic stress disorder (PTSD) can be a severe problem, affecting veterans and military personnel at higher rates than the general community. First-line treatment for PTSD, prolonged exposure (PE), is typically delivered weekly for 10-12 weeks, however this duration can pose a barrier to accessing and completing the treatment, particularly for current serving military. This paper presents the RESTORE trial protocol, the first randomized controlled trial of massed PE therapy outside of the United States and by an independent research group. One hundred and thirty-five Australian Defence Force members and veterans (18-80 years) who meet criteria for PTSD related to a military trauma will be randomly allocated to one of two conditions: standard PE (SPE; 10 weekly 90-min sessions) or massed PE (MPE; 10 daily 90-min sessions). Across eight sites, patients will be assessed at pre-treatment, and at 4 weeks, 12 weeks, and 12 months post-treatment commencement. The primary outcome is clinician-measured and self-reported PTSD symptom severity at the 12 week assessment. We hypothesize that MPE will be as effective as SPE in reducing PTSD severity at 12 weeks post-treatment commencement. The adaptation and testing of evidence-based interventions is critical to reduce barriers to treatment uptake among veterans and military personnel. Outcomes of this study have the potential to result in international, cross-service uptake and delivery of this rapid treatment for veterans and military members, as well as civilians, thereby improving clinical outcomes for patients and their families.