Evaluating Treatments for Suicidal Veterans With PTSD

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dialectical Behavior Therapy — BEHAVIORAL
  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 — BEHAVIORAL
  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 — BEHAVIORAL
  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 — BEHAVIORAL
  Standard VA suicide risk management procedures, including comprehensive suicide risk assessment and safety planning.

Study Details

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.

Key Dates

Start date

Jul 8, 2024

Status verified

Dec 2025

Primary completion

Apr 30, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

125 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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).

Primary Outcome Measure

Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF) [ Time Frame: Baseline to 16 months ]

Central Contacts

• Melanie S Harned, PhD
  (206) 277-3650
  [email protected]
• John C Fortney, PhD
  (206) 764-2821
  [email protected]

Locations (4)

Find similar trials in Minneapolis, MN

Related Studies

• Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients
  PHASE4 · Recruiting · Texas Tech University Health Sciences Center · Lubbock, Texas
• Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
  PHASE2 · Recruiting · VA Office of Research and Development · San Diego, California
• NightWare and Cardiovascular Health in Veterans With PTSD
  Recruiting · VA Office of Research and Development · Aurora, Colorado
• Developing and Testing Innovative Care Pathways for Screening and Treatment of OUD/PTSD in Jails
  Enrolling By Invitation · University of Arkansas · Little Rock, Arkansas