Evaluating Treatments for Suicidal Veterans With PTSD

Background: Posttraumatic stress disorder (PTSD) is a significant risk factor for suicideamong Veterans. Evidence‐based psychotherapies (EBPs) for PTSD reduce suicide risk, butVeterans at elevated acute risk for suicide, such as those who have engaged inself‐directed violence (SDV), rarely receive these treatments. This is largely due to thehistorical exclusion of high‐risk individuals from PTSD treatment trials, which hasresulted in a lack of evidence‐based guidance about indicated treatments for thispopulation. Without such guidance, clinicians are often reluctant to use EBPs for PTSDwith suicidal individuals. A treatment that combines Dialectical Behavior Therapy (DBT),a suicide‐focused EBP, with the DBT Prolonged Exposure (DBT PE) protocol for PTSD hasbeen developed for this high‐risk population and shows promise in reducing both SDV andPTSD while being feasible, acceptable, and safe to deliver. However, a large‐scalerandomized controlled trial (RCT) is needed. This study will compare the effectiveness ofDBT + DBT PE to the current VHA gold standard of care for this population, ProlongedExposure therapy augmented with suicide risk management (PE + SRM), while also examiningthe potential for implementation of both interventions in VHA.Significance: There is a critical gap in knowledge about how to treat PTSD amongindividuals at high risk for suicidal behavior. As a result, VA/DoD Clinical PracticeGuidelines do not specify indicated treatment strategies for this population. Expertshave recommended two approaches to facilitate the safe and effective use of EBPs for PTSDwith individuals at elevated acute suicide risk, including combining these treatmentswith suicide‐focused EBPs or augmenting them with suicide risk management strategies.This project will help to fill this critical gap by rigorously evaluating these twoapproaches among Veterans with SDV. The results will provide important information toinform guidelines about indicated treatments for this high‐risk population.Innovativeness: This will be the first large‐scale RCT to evaluate treatments for PTSDamong Veterans who have engaged in SDV, an HSR&D high priority group. The DBT + DBT PEintervention is the first treatment designed to address both SDV and PTSD, and resultswill indicate if this novel treatment improves outcomes compared to the current VHA goldstandard of care. To facilitate more rapid implementation of these findings into clinicalpractice, implementation barriers and facilitators for both treatments will also beevaluated.Specific Aims: This study will randomize 200 Veterans with PTSD, recent and repeated SDV,current suicidal ideation, and emotion dysregulation to DBT + DBT PE (intervention) or PE+ SRM (control). Aim 1 will test the hypothesis that DBT + DBT PE will be superior to PE+ SRM in improving clinical outcomes and engagement in trauma‐focused treatment.Exploratory analyses will examine Veteran characteristics that may predict betterengagement and outcomes in DBT + DBT PE versus PE + SRM. Aim 2 will examine barriers andfacilitators to implementation of both treatments.Methods: This is a multi‐site hybrid type 1 effectiveness‐implementation trial. Veteranswill be treated in outpatient settings at three VA sites and assessed at 5 points over 18months. A mixed‐methods approach will be used to evaluate barriers and facilitators toimplementation, including conducting interviews with 45 key stakeholders (Veterans,providers, and leadership).Primary Outcomes/Endpoints: Primary outcomes will be reductions in SDV episodes at18‐month follow‐up and reductions in PTSD severity at post‐treatment.Implementation/Next Steps: This project will provide much‐needed information about how tosafely and effectively treat PTSD among Veterans at elevated acute risk for suicide. Ifone or both treatments are found effective, Aim 2 will provide vital information abouthow to maximize future implementation success. Future implementation activities would becoordinated with the investigators' national operational partners.