Clinical trial NCT05974631: Evaluating Treatments for Suicidal Veterans With PTSD
Official title: A Hybrid Effectiveness-Implementation Trial of Treatments for Veterans With PTSD at Elevated Acute Risk for Suicide
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Self-directed Violence
Post-traumatic Stress Disorder (PTSD)
Keywords: Stress Disorders, Post-Traumatic
Suicide
Self-Injurious Behavior
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-08-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm randomized clinical trial
Primary purpose: TREATMENT

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.

Detailed description: Background: Posttraumatic stress disorder (PTSD) is a significant risk factor for suicide among Veterans. Evidence-based psychotherapies (EBPs) for PTSD reduce suicide risk, but Veterans at elevated acute risk for suicide, such as those who have engaged in self-directed violence (SDV), rarely receive these treatments. This is largely due to the historical exclusion of high-risk individuals from PTSD treatment trials, which has resulted in a lack of evidence-based guidance about indicated treatments for this population. Without such guidance, clinicians are often reluctant to use EBPs for PTSD with suicidal individuals. A treatment that combines Dialectical Behavior Therapy (DBT), a suicide-focused EBP, with the DBT Prolonged Exposure (DBT PE) protocol for PTSD has been developed for this high-risk population and shows promise in reducing both SDV and PTSD while being feasible, acceptable, and safe to deliver. However, a large-scale randomized controlled trial (RCT) is needed. This study will compare the effectiveness of DBT + DBT PE to the current VHA gold standard of care for this population, Prolonged Exposure therapy augmented with suicide risk management (PE + SRM), while also examining the potential for implementation of both interventions in VHA.

Significance: There is a critical gap in knowledge about how to treat PTSD among individuals at high risk for suicidal behavior. As a result, VA/DoD Clinical Practice Guidelines do not specify indicated treatment strategies for this population. Experts have recommended two approaches to facilitate the safe and effective use of EBPs for PTSD with individuals at elevated acute suicide risk, including combining these treatments with suicide-focused EBPs or augmenting them with suicide risk management strategies. This project will help to fill this critical gap by rigorously evaluating these two approaches among Veterans with SDV. The results will provide important information to inform guidelines about indicated treatments for this high-risk population.

Innovativeness: This will be the first large-scale RCT to evaluate treatments for PTSD among Veterans who have engaged in SDV, an HSR\&D high priority group. The DBT + DBT PE intervention is the first treatment designed to address both SDV and PTSD, and results will indicate if this novel treatment improves outcomes compared to the current VHA gold standard of care. To facilitate more rapid implementation of these findings into clinical practice, implementation barriers and facilitators for both treatments will also be evaluated.

Specific Aims: This study will randomize 200 Veterans with PTSD, recent and repeated SDV, current suicidal ideation, and emotion dysregulation to DBT + DBT PE (intervention) or PE + SRM (control). Aim 1 will test the hypothesis that DBT + DBT PE will be superior to PE + SRM in improving clinical outcomes and engagement in trauma-focused treatment. Exploratory analyses will examine Veteran characteristics that may predict better engagement and outcomes in DBT + DBT PE versus PE + SRM. Aim 2 will examine barriers and facilitators to implementation of both treatments.

Methods: This is a multi-site hybrid type 1 effectiveness-implementation trial. Veterans will be treated in outpatient settings at three VA sites and assessed at 5 points over 18 months. A mixed-methods approach will be used to evaluate barriers and facilitators to implementation, including conducting interviews with 45 key stakeholders (Veterans, providers, and leadership).

Primary Outcomes/Endpoints: Primary outcomes will be reductions in SDV episodes at 18-month follow-up and reductions in PTSD severity at post-treatment.

Implementation/Next Steps: This project will provide much-needed information about how to safely and effectively treat PTSD among Veterans at elevated acute risk for suicide. If one or both treatments are found effective, Aim 2 will provide vital information about how to maximize future implementation success. Future implementation activities would be coordinated with the investigators' national operational partners.

Eligibility criteria: Inclusion Criteria:

* PTSD
* Recent and repeated self-directed violence
* Current suicidal ideation
* Emotion dysregulation
* Veteran eligible for VHA mental health care at participating site (Seattle, Minneapolis, and Durham VAs)
* Age 18+
* 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

Primary outcomes:
measure: Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF)
timeFrame: Baseline to 18 months
measure: Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
timeFrame: Baseline to 18 months
Secondary outcomes:
measure: Columbia - Suicide Severity Rating Scale (C-SSRS), Suicide Ideation subscales
timeFrame: Baseline to 18 months
measure: PROMIS Global Mental Health
timeFrame: Baseline to 18 months
measure: Difficulties in Emotion Regulation Scale-16 (DERS-16)
timeFrame: Baseline to 18 months
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline to 18 months
measure: Self-Injurious Thoughts and Behaviors Interview Revised Short Form (SITBI-R-SF)
timeFrame: Baseline to 18 months
measure: Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
timeFrame: Baseline to 18 months
Other outcomes:
measure: Treatment History Interview (THI)
timeFrame: Baseline to 18 months
measure: VA Service Use Form
timeFrame: Baseline to 18 months
measure: Credibility Expectancy Questionnaire (CEQ)
timeFrame: Baseline to 18 months
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Post-treatment (4 months in PE + SRM, 12 months in DBT + DBT PE)
measure: Dissociative Experiences Scale - Taxon (DES-T)
timeFrame: Baseline to 18 months
measure: Trauma-Related Shame Inventory (TRSI)
timeFrame: Baseline to 18 months
measure: Self-Compassion Scale (SCS)
timeFrame: Baseline to 18 months
measure: Borderline Symptom List - Behavioral Supplement (BSL-BS)
timeFrame: Baseline to 18 months
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline to 18 months
measure: Post-Traumatic Cognitions Inventory-9 (PTCI-9)
timeFrame: Baseline to 18 months
measure: PROMIS Sadness
timeFrame: Baseline to 18 months
measure: PROMIS Fear-Affect
timeFrame: Baseline to 18 months
measure: PROMIS Anger-Affect
timeFrame: Baseline to 18 months
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Melanie S Harned, PhD
role: PRINCIPAL_INVESTIGATOR
References: