Early Support after Exposure to Trauma (EASE): protocol for a hybrid effectiveness-implementation trial of an internet-based intervention for PTSD prevention.

BACKGROUND

Post-traumatic stress disorder (PTSD) can have detrimental effects for those afflicted and is associated with increased health care utilization and substantial societal costs. Thus, there is a need for accessible, effective, and cost-efficient preventive interventions for post-traumatic psychological sequelae. Research indicates that trauma-focused cognitive-behavioral therapy (CBT-T) could effectively prevent PTSD when applied as an indicated secondary prevention. CIPE is a scalable, low-threshold, therapist-assisted digital CBT-T, which could be readily implemented in services delivering psychosocial support after traumatic incidents if proven effective and cost-effective. The Early Support after Exposure to Trauma (EASE) study evaluates the effectiveness, cost-effectiveness, and implementation of Condensed Internet-delivered Prolonged Exposure (CIPE), applied as an indicated secondary prevention in the context of Norwegian municipal crisis teams.

METHODS/

DESIGN

The EASE study is a hybrid Type 1 effectiveness and implementation trial. The effectiveness trial is a parallel two-armed multicenter randomized controlled add-on superiority trial, enrolling individuals who receive support from psychosocial crisis teams within 7 weeks after trauma. Participants are randomized to CIPE + treatment as usual (TAU) or TAU only. The primary outcome is the level of PTSD symptoms 6 weeks after randomization (10-13 weeks post trauma). Secondary outcomes include symptoms of depression and insomnia, quality of life, and CIPE cost-effectiveness. The implementation trial examines policy-level factors influencing CIPE implementation, using the Exploration, Preparation, Implementation, Sustainment framework.

DISCUSSION: This study will guide further research, policy shaping, and clinical initiatives for implementing preventive interventions aimed at reducing post-traumatic psychological sequelae by integrating evidence-based interventions into routine psychosocial services.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06592677 . Registered on 10.09.2024.