Evaluating treatments for suicidal veterans with PTSD
A Hybrid Effectiveness-Implementation Trial of Treatments for Veterans With PTSD at Elevated Acute Risk for Suicide
This study is testing a new combined therapy for veterans with PTSD who are at risk of suicide to see if it works better than the usual treatment they currently receive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 4 sites (Minneapolis, Minnesota and 3 other locations) |
| Trial ID | NCT05974631 on ClinicalTrials.gov |
What this trial studies
This study aims to address the treatment gap for Veterans with PTSD who are at high risk for suicide. It will compare the effectiveness of a combined treatment approach using Dialectical Behavior Therapy (DBT) and the DBT Prolonged Exposure protocol against the current standard care of Prolonged Exposure therapy with suicide risk management. The study will also explore the implementation challenges of these treatments within Veterans Affairs (VA) settings. By focusing on this high-risk population, the research seeks to provide evidence-based guidance for clinicians.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans aged 18 and older who have PTSD, recent self-directed violence, current suicidal ideation, and emotion dysregulation.
Not a fit: Patients who are unable to maintain safety independently or have recently received sufficient doses of DBT or PE may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and reduced suicide risk for Veterans suffering from PTSD.
How similar studies have performed: Previous studies have shown promise in combining DBT with PTSD treatments, but this specific approach is novel and aims to fill a critical gap in treatment for high-risk Veterans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PTSD * Recent and repeated self-directed violence * Current suicidal ideation * Emotion dysregulation * Veteran eligible for VHA mental health care at participating site * Age 18+ * 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 this trial is running
Minneapolis, Minnesota and 3 other locations
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (Recruiting)
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (Recruiting)
- South Texas Health Care System, San Antonio, TX — San Antonio, Texas, United States (Recruiting)
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Melanie S Harned, PhD — VA Puget Sound Health Care System Seattle Division, Seattle, WA
- Study coordinator: Melanie S Harned, PhD
- Email: melanie.harned@va.gov
- Phone: (206) 277-3650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.