Evaluating Treatments for Suicidal Veterans With PTSD

NCT05974631 | Recruiting DMC

• 1 other identifier: SDR 22-185
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 4

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)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF)

  Number of self-directed violence episodes

  Baseline to 16 months

• Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)

  Total Severity Score (range = 0 - 200, higher is worse)

  Baseline to 16 months

Secondary Outcomes (6)

• Columbia - Suicide Severity Rating Scale (C-SSRS), Suicide Ideation subscales

  Baseline to 16 months

• PROMIS Global Mental Health

  Baseline to 16 months

• Difficulties in Emotion Regulation Scale-16 (DERS-16)

  Baseline to 16 months

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

  Baseline to 16 months

• Self-Injurious Thoughts and Behaviors Interview Revised Short Form (SITBI-R-SF)

  Baseline to 16 months

Other Outcomes (13)

• Treatment History Interview (THI)

  Baseline to 16 months

• VA Service Use Form

  Baseline to 16 months

• Credibility Expectancy Questionnaire (CEQ)

  Baseline to 16 months

Study Arms (2)

DBT + DBT PE

EXPERIMENTAL

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

Behavioral: Dialectical Behavior Therapy; Behavioral: Dialectical Behavior Therapy Prolonged Exposure protocol

PE + SRM

ACTIVE COMPARATOR

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

Behavioral: Prolonged Exposure therapy; Behavioral: Suicide risk management

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).

Also known as: DBT

DBT + DBT PE

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.

Also known as: PE

PE + SRM

Suicide risk management BEHAVIORAL

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

Also known as: SRM

PE + SRM

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).

Also known as: DBT PE

DBT + DBT PE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PTSD
• Recent and repeated self-directed violence
• Current suicidal ideation
• Emotion dysregulation
• Veteran eligible for VHA mental health care at participating site
• Age 18+
• Willing to participate in all study activities

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

RECRUITING

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

RECRUITING

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229-4404, United States

RECRUITING

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

Seattle, Washington, 98108-1532, United States

RECRUITING

MeSH Terms

Conditions

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

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Melanie S Harned, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie S Harned, PhD

CONTACT

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

John C Fortney, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be masked to participants' treatment condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 2-arm randomized clinical trial

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: August 3, 2023
• Study Start: July 8, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Starting after publication of relevant data
• Access Criteria: Data may be shared in response to written requests submitted to the PI by other researchers. Such data sharing will take place under a written agreement that prohibits the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are in the dataset.

Locations

US (4)