Trials · 2026
Early Support after Exposure to Trauma (EASE): protocol for a hybrid effectiveness-implementation trial of an internet-based intervention for PTSD prevention.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Lassen Espen Rasmussen, Birkeland Marianne Skogbrott, Egeland Karina, Stene Lise Eilin, Brodersen Dorte, Ekornås Belinda, Reinholdt Nils Petter, Kjerstad Egil, Lamu Admassu N, Aarons Gregory A, Crable Erika L, Bragesjö Maria, Bækkelund Harald
Аннотация
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.
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.