Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05974631

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

Led by VA Office of Research and Development · Updated on 2025-12-23

125

Participants Needed

4

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating treatments for Veterans with Posttraumatic Stress Disorder (PTSD) who are at high risk for suicide due to recent self-directed violence and current suicidal thoughts. This study compares two therapies: a combined Dialectical Behavior Therapy (DBT) plus DBT Prolonged Exposure (DBT PE) protocol against the current standard care, Prolonged Exposure therapy with suicide risk management (PE + SRM). The goal is to see which approach better reduces PTSD symptoms and suicidal behaviors, while also exploring challenges in applying these treatments in VA settings. Participants will be randomly assigned to one of two treatment groups. One group receives one year of standard DBT, including individual therapy, group skills training, coaching, and team consultation, combined with the DBT PE protocol for PTSD delivered in weekly individual sessions. The other group receives up to 18 weekly sessions of Prolonged Exposure therapy together with suicide risk management strategies. The study is conducted across three VA outpatient sites. Veterans will be assessed at five points over 16 months to track changes in self-injurious thoughts and behaviors and PTSD severity. Additional evaluations include mental health, emotion regulation, disability, and suicide ideation scales. Researchers will also interview veterans, providers, and leaders to understand factors affecting treatment implementation. Overall participation lasts 16 months, with ongoing safety monitoring and outcome measurements.

CONDITIONS

Brief Title

Evaluating Treatments for Suicidal Veterans With PTSD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with PTSD
  • Recent and repeated self-directed violence
  • Current suicidal ideation
  • Emotion dysregulation
  • Eligible for VA mental health care at a participating site
  • Age 18 years or older
  • Willing to participate in all study activities
Not Eligible

You will not qualify if you...

  • Unable to maintain safety independently
  • Currently engaged in or recent (past year) history of sufficient Dialectical Behavior Therapy or Prolonged Exposure therapy
  • Plans to move away or be unavailable for more than 4 weeks in the next 18 months
  • Insufficient English proficiency or moderate to severe cognitive impairment that prevents understanding study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 12 months

Participants receive one year of treatment, either combining Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure protocol for PTSD, or Prolonged Exposure therapy augmented with suicide risk management.

Weekly individual therapy sessions; DBT group skills training sessions weekly for DBT + DBT PE participants; coaching as needed

Follow-up Assessments

Duration - Up to 16 months from baseline

Participants are assessed at multiple points over 16 months to evaluate clinical outcomes and treatment engagement.

5 assessment visits (in-person or remote)

Trial Site Locations

Total: 4 locations

1

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States, 55417-2309

Actively Recruiting

2

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705-3875

Actively Recruiting

3

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States, 78229-4404

Actively Recruiting

4

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

Seattle, Washington, United States, 98108-1532

Actively Recruiting

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Research Team

M

Melanie S Harned, PhD

J

John C Fortney, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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