Evaluating Treatments for Suicidal Veterans With PTSD

Post-traumatic Stress Disorder (PTSD) Clinical Trial

Official title:

A Hybrid Effectiveness-Implementation Trial of Treatments for Veterans With PTSD at Elevated Acute Risk for Suicide

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05974631
• Other study ID #: SDR 22-185
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: July 30, 2027

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Melanie S Harned, PhD
• Phone: (206) 277-3650
• Email: melanie.harned[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment History Interview (THI)	Non-VA psychotherapy, psychiatric crisis services, and psychotropic medications	Baseline to 18 months
Other	VA Service Use Form	VA mental health service use and psychotropic medications	Baseline to 18 months
Other	Credibility Expectancy Questionnaire (CEQ)	Total score (range = 1 - 7, higher is better)	Baseline to 18 months
Other	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)
Other	Dissociative Experiences Scale - Taxon (DES-T)	Total score (range = 0 - 80, higher is worse)	Baseline to 18 months
Other	Trauma-Related Shame Inventory (TRSI)	Total score (range = 0 - 72, higher is worse)	Baseline to 18 months
Other	Self-Compassion Scale (SCS)	Total score (range = 1 - 5, higher is better)	Baseline to 18 months
Other	Borderline Symptom List - Behavioral Supplement (BSL-BS)	Total score (range = 0 - 44, higher is worse)	Baseline to 18 months
Other	PTSD Checklist for DSM-5 (PCL-5)	Total severity score (range = 0 - 80, higher is worse)	Baseline to 18 months
Other	Post-Traumatic Cognitions Inventory-9 (PTCI-9)	Total score (range = 9 to 63, higher is worse)	Baseline to 18 months
Primary	Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF)	Number of self-directed violence episodes	Baseline to 18 months
Primary	Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)	Total Severity Score (range = 0 - 200, higher is worse)	Baseline to 18 months
Secondary	Columbia - Suicide Severity Rating Scale (C-SSRS), Suicide Ideation subscales	Total Score (range = 0 - 5, higher is worse)	Baseline to 18 months
Secondary	Brief Symptom Inventory (BSI)	Global Severity Index (range = 0 to 4, higher is worse)	Baseline to 18 months
Secondary	Difficulties in Emotion Regulation Scale-16 (DERS-16)	Total Score (range = 16 - 80, higher is worse)	Baseline to 18 months
Secondary	World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	General Disability Score (range = 12 - 60, higher is worse)	Baseline to 18 months
Secondary	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 18 months
Secondary	Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)	PTSD diagnostic status	Baseline to 18 months