NCT05974631 · VA Office of Research and Development
Evaluating Treatments for Suicidal Veterans With PTSD
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF)
Time frame: Baseline to 16 months
Number of self-directed violence episodes
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Time frame: Baseline to 16 months
Total Severity Score (range = 0 - 200, higher is worse)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Recent and repeated self-directed violence
- Current suicidal ideation
- Emotion dysregulation
- Veteran eligible for VHA mental health care at participating site
- Willing to participate in all study activities
Exclusion criteria
- Unable to maintain safety independently
- Currently engaged in and/or recent (past year) history of receiving a sufficient dose of DBT or PE
- Plan to move away or be unavailable for \>4 weeks in the next 18 months
- Unable to sufficiently comprehend study procedures due to lack of English proficiency or moderate to severe cognitive impairment
Where
- Minneapolis, Minnesota
- Durham, North Carolina
- San Antonio, Texas
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations