Recruiting

PTSD Treatments

Sponsor:

VA Office of Research and Development

Code:

NCT05974631

Conditions

Self-directed Violence

Post-traumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dialectical Behavior Therapy

Dialectical Behavior Therapy Prolonged Exposure protocol

Prolonged Exposure therapy

Suicide risk management

Study Details

Brief 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.

Conditions

Self-directed Violence

Post-traumatic Stress Disorder (PTSD)

Study ID

NCT05974631

Start date

Jul 8, 2024

Status verified date

Jul, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • PTSD
  • 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

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DBT + DBT PE

This condition combines one year of standard Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure (DBT PE) protocol for PTSD.

active comparator: PE + SRM

This condition provides up to 18 sessions of Prolonged Exposure therapy (PE) for PTSD augmented with suicide risk management (SRM).

Interventions

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).

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).

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.

Suicide risk management

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

Primary outcome measure

  • Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF) [ Time Frame: Baseline to 16 months ]
  • Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) [ Time Frame: Baseline to 16 months ]

Central Contacts and Locations

Central contacts

Melanie S Harned, PhD

(206) 277-3650melanie.harned@va.gov

John C Fortney, PhD

(206) 764-2821John.Fortney@va.gov

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Lindsay Andrews-Wiebusch, PhD

(612) 629-7656Lindsay.Andrews-Wiebusch@va.gov

Laura A Meis, PhD

(612) 467-4516laura.meis@va.gov

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Daniel Blalock, PhD

(919) 286-0411daniel.blalock@va.gov

Charlotte Ready, PhD

(919) 286-0411Charlotte.Ready@va.gov

South Texas Health Care System, San Antonio, TX

Recruiting

San Antonio, Texas, United States, 78229-4404

Contacts

Julia Carter, PhD

830-237-2958julia.carter@va.gov

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

Recruiting

Seattle, Washington, United States, 98108-1532

Contacts

Melanie S Harned, PhD

(206) 277-3650melanie.harned@va.gov

John C Fortney, PhD

(206) 764-2821John.Fortney@va.gov

Principal Investigator:

Melanie S Harned, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-16.