RecruitingNot ApplicableNCT05974631

Evaluating Treatments for Suicidal Veterans With PTSD

A Hybrid Effectiveness-Implementation Trial of Treatments for Veterans With PTSD at Elevated Acute Risk for Suicide

Sponsor

VA Office of Research and Development

Enrollment

125 participants

Start Date

Jul 8, 2024

Study Type

INTERVENTIONAL

Conditions

Self-directed Violence

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two established therapies — Dialectical Behavior Therapy (DBT) and Prolonged Exposure (PE) — for veterans with PTSD who have recently harmed themselves or have ongoing thoughts of suicide. The goal is to understand which approach works better for this high-risk group. **You may be eligible if...** - You are a veteran aged 18 or older eligible for VA mental health care - You have been diagnosed with PTSD - You have recently engaged in self-harm or have current suicidal thoughts - You struggle with emotional regulation - You can commit to study activities over the next 18 months **You may NOT be eligible if...** - You are unable to maintain your own safety independently - You have recently (within the past year) received a full course of DBT or Prolonged Exposure therapy - You plan to be unavailable or relocate for more than 4 weeks in the next 18 months - You do not speak English at a sufficient level to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDialectical 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).

BEHAVIORALDialectical 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).

BEHAVIORALProlonged 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.

BEHAVIORALSuicide risk management

Standard VA suicide risk management procedures, including comprehensive suicide risk assessment and safety planning.

Locations(4)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

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NCT05974631