Evaluating psychotherapies for veterans with PTSD at elevated acute risk of suicide: Protocol for a multi-site type 1 hybrid effectiveness-implementation trial.

BACKGROUND: Posttraumatic stress disorder (PTSD) is a significant risk factor for suicide among veterans, but there is a critical knowledge gap about how to treat PTSD in the context of elevated acute suicide risk. Prior research suggests that a treatment that combines Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure protocol (DBT PE) reduces PTSD and self-directed violence (SDV) among high-risk individuals while also being feasible, acceptable, and safe to deliver. However, a large-scale randomized controlled trial is needed. This study will compare the effectiveness of DBT + DBT PE to the current gold standard of care in the Veterans Health Administration (VHA), Prolonged Exposure therapy augmented with suicide risk management (PE + SRM), while also examining barriers and facilitators to implementing these treatments in VHA. METHODS: This multi-site hybrid type 1 effectiveness-implementation trial will randomize 125 veterans with PTSD, recent and repeated SDV, suicidal ideation, and emotion dysregulation to DBT + DBT PE (12 months) or PE + SRM (up to 20 weeks). Participants will be treated at 4 VHA sites and evaluated by masked assessors at 5 points over 16 months. Implementation determinants will be assessed among veterans, providers, and administrators using a mixed methods approach. RESULTS: The project is ongoing and results will be reported in future manuscripts. CONCLUSION: This project will yield generalizable knowledge about how to safely and effectively treat PTSD among individuals at elevated acute risk of suicide as well as how to maximize future implementation success if either treatment is found effective. TRIAL REGISTRATION: ClinicalTrials.govNCT05974631, date of registration July 25, 2023, https://clinicaltrials.gov/study/NCT05974631.