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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.
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 125 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 16 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 16-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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| PE + SRM | Active Comparator | This condition provides up to 18 sessions of Prolonged Exposure therapy (PE) for PTSD augmented with suicide risk management (SRM). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Columbia - Suicide Severity Rating Scale (C-SSRS), Suicide Ideation subscales | Total Score (range = 0 - 5, higher is worse) | Baseline to 16 months |
| PROMIS Global Mental Health | Total Score (range = 4 - 20, higher is better) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment History Interview (THI) | Non-VA psychotherapy, psychiatric crisis services, and psychotropic medications | Baseline to 16 months |
| VA Service Use Form | VA mental health service use and psychotropic medications |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melanie S Harned, PhD | Contact | (206) 277-3650 | melanie.harned@va.gov | |
| John C Fortney, PhD | Contact | (206) 764-2821 | John.Fortney@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Melanie S Harned, PhD | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN | Recruiting | Minneapolis | Minnesota | 55417-2309 | United States |
De-identified, anonymized data that underlie results in a publication may be shared.
Starting after publication of relevant data
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.
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2-arm randomized clinical trial
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Outcome assessors will be masked to participants' treatment condition
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| 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). |
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| 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. |
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| Suicide risk management | Behavioral | Standard VA suicide risk management procedures, including comprehensive suicide risk assessment and safety planning. |
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| Baseline to 16 months |
| Difficulties in Emotion Regulation Scale-16 (DERS-16) | Total Score (range = 16 - 80, higher is worse) | Baseline to 16 months |
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | General Disability Score (range = 12 - 60, higher is worse) | Baseline to 16 months |
| Self-Injurious Thoughts and Behaviors Interview Revised Short Form (SITBI-R-SF) | Non-suicidal self-injury frequency and remission; Suicide attempt frequency and remission | Baseline to 16 months |
| Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) | PTSD diagnostic status | Baseline to 16 months |
| Baseline to 16 months |
| Credibility Expectancy Questionnaire (CEQ) | Total score (range = 1 - 7, higher is better) | Baseline to 16 months |
| Client Satisfaction Questionnaire (CSQ) | Total score (range = 8 - 32, higher is better) | Post-treatment (4 months in PE + SRM, 12 months in DBT + DBT PE) |
| Dissociative Experiences Scale - Taxon (DES-T) | Total score (range = 0 - 80, higher is worse) | Baseline to 16 months |
| Trauma-Related Shame Inventory (TRSI) | Total score (range = 0 - 72, higher is worse) | Baseline to 16 months |
| Self-Compassion Scale (SCS) | Total score (range = 1 - 5, higher is better) | Baseline to 16 months |
| Borderline Symptom List - Behavioral Supplement (BSL-BS) | Total score (range = 0 - 44, higher is worse) | Baseline to 16 months |
| PTSD Checklist for DSM-5 (PCL-5) | Total severity score (range = 0 - 80, higher is worse) | Baseline to 16 months |
| Post-Traumatic Cognitions Inventory-9 (PTCI-9) | Total score (range = 9 to 63, higher is worse) | Baseline to 16 months |
| PROMIS Sadness | Total score (range = 8 - 40, higher is worse) | Baseline to 16 months |
| PROMIS Fear-Affect | Total score (range = 7 - 35, higher is worse) | Baseline to 16 months |
| PROMIS Anger-Affect | Total score (range = 5 - 25, higher is worse) | Baseline to 16 months |
| Durham VA Medical Center, Durham, NC | Recruiting | Durham | North Carolina | 27705-3875 | United States |
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| South Texas Health Care System, San Antonio, TX | Recruiting | San Antonio | Texas | 78229-4404 | United States |
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| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Recruiting | Seattle | Washington | 98108-1532 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000077252 | Dialectical Behavior Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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