Evaluating Treatments for Suicidal Veterans With PTSD
NCT05974631 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2025-12-23
Summary
Posttraumatic Stress Disorder (PTSD) is a significant driver of suicide risk among Veterans, but there is a critical knowledge gap about how to treat PTSD among people at elevated risk for suicide. Although evidence-based treatments for PTSD reduce suicide risk, Veterans at high risk for suicidal behavior rarely receive these potentially life-saving treatments. Prior research suggests that a treatment that combines Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure protocol (DBT PE) for PTSD improves both PTSD and suicide-related outcomes. This study will evaluate whether DBT + DBT PE improves these outcomes more than Prolonged Exposure plus suicide risk management, the gold standard VA care for this population. The proposed study will also examine factors that make it easier and harder to implement these treatments in VA settings. The results will help to inform treatment guidelines for this high-priority Veteran population.
Conditions
- Self-directed Violence
- Post-traumatic Stress Disorder (PTSD)
Interventions
- BEHAVIORAL
-
Dialectical Behavior Therapy
Standard Dialectical Behavior Therapy (DBT), including DBT individual therapy (1 hour/week), DBT group skills training (2 hours/week), between-session coaching (as needed during business hours), and therapist consultation team (1-1.5 hours/week).
- BEHAVIORAL
-
Dialectical Behavior Therapy Prolonged Exposure protocol
DBT PE is designed to be integrated into DBT to formally treat PTSD once patients meet standardized readiness criteria. The core procedures are in vivo and imaginal exposure with processing that are delivered in individual therapy sessions (1.5 hours/week).
- BEHAVIORAL
-
Prolonged Exposure therapy
Standard PE is delivered in individual therapy sessions (1.5 hours/week) and uses the core procedures of in vivo and imaginal exposure with processing.
- BEHAVIORAL
-
Suicide risk management
Standard VA suicide risk management procedures, including comprehensive suicide risk assessment and safety planning.
Sponsors & Collaborators
-
VA Office of Research and Development
lead FED
Principal Investigators
-
Melanie S Harned, PhD · VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-08
- Primary Completion
- 2027-04-30
- Completion
- 2027-08-31
Countries
- United States
Study Locations
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