RECRUITING

Evaluating Treatments for Suicidal Veterans With PTSD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-08
Study Completion:2027-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05974631

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PTSD
  2. * Recent and repeated self-directed violence
  3. * Current suicidal ideation
  4. * Emotion dysregulation
  5. * Veteran eligible for VHA mental health care at participating site (Seattle, Minneapolis, and Durham VAs)
  6. * Age 18+
  7. * Willing to participate in all study activities
  1. * Unable to maintain safety independently
  2. * Currently engaged in and/or recent (past year) history of receiving a sufficient dose of DBT or PE
  3. * Plan to move away or be unavailable for \>4 weeks in the next 18 months
  4. * Unable to sufficiently comprehend study procedures due to lack of English proficiency or moderate to severe cognitive impairment

Contacts and Locations

Study Contact

Melanie S Harned, PhD
CONTACT
(206) 277-3650
melanie.harned@va.gov
John C Fortney, PhD
CONTACT
(206) 764-2821
John.Fortney@va.gov

Principal Investigator

Melanie S Harned, PhD
PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Locations (Sites)

Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Melanie S Harned, PhD, PRINCIPAL_INVESTIGATOR, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-08
Study Completion Date2027-07-30

Study Record Updates

Study Start Date2024-07-08
Study Completion Date2027-07-30

Terms related to this study

Keywords Provided by Researchers

  • Stress Disorders, Post-Traumatic
  • Suicide
  • Self-Injurious Behavior

Additional Relevant MeSH Terms

  • Self-directed Violence
  • Post-traumatic Stress Disorder (PTSD)