Evaluating Treatments for Suicidal Veterans With PTSD

• ClinicalTrials.gov Identifier: NCT05974631
• Recruitment Status: Not yet recruiting
• First Posted: August 3, 2023
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Self-directed Violence; Post-traumatic Stress Disorder (PTSD)	Behavioral: Dialectical Behavior Therapy; Behavioral: Dialectical Behavior Therapy Prolonged Exposure protocol; Behavioral: Prolonged Exposure therapy; Behavioral: Suicide risk management	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 2-arm randomized clinical trial
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcome assessors will be masked to participants' treatment condition
• Primary Purpose: Treatment
• Official Title: A Hybrid Effectiveness-Implementation Trial of Treatments for Veterans With PTSD at Elevated Acute Risk for Suicide
• Estimated Study Start Date: June 3, 2024
• Estimated Primary Completion Date: April 30, 2027
• Estimated Study Completion Date: July 30, 2027

Arms and Interventions

Arm	Intervention/treatment
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.	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).; Other Name: DBT; Behavioral: 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).; Other Name: DBT PE
Active Comparator: PE + SRM; This condition provides up to 18 sessions of Prolonged Exposure therapy (PE) for PTSD augmented with suicide risk management (SRM).	Behavioral: 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.; Other Name: PE; Behavioral: Suicide risk management; Standard VA suicide risk management procedures, including comprehensive suicide risk assessment and safety planning.; Other Name: SRM

Outcome Measures

Primary Outcome Measures :

1. Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF) [ Time Frame: Baseline to 18 months ]
   Number of self-directed violence episodes
2. Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) [ Time Frame: Baseline to 18 months ]
   Total Severity Score (range = 0 - 200, higher is worse)

Secondary Outcome Measures :

1. Columbia - Suicide Severity Rating Scale (C-SSRS), Suicide Ideation subscales [ Time Frame: Baseline to 18 months ]
   Total Score (range = 0 - 5, higher is worse)
2. Brief Symptom Inventory (BSI) [ Time Frame: Baseline to 18 months ]
   Global Severity Index (range = 0 to 4, higher is worse)
3. Difficulties in Emotion Regulation Scale-16 (DERS-16) [ Time Frame: Baseline to 18 months ]
   Total Score (range = 16 - 80, higher is worse)
4. World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: Baseline to 18 months ]
   General Disability Score (range = 12 - 60, higher is worse)
5. Self-Injurious Thoughts and Behaviors Interview Revised Short Form (SITBI-R-SF) [ Time Frame: Baseline to 18 months ]
   Non-suicidal self-injury frequency and remission; Suicide attempt frequency and remission
6. Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) [ Time Frame: Baseline to 18 months ]
   PTSD diagnostic status

Other Outcome Measures:

1. Treatment History Interview (THI) [ Time Frame: Baseline to 18 months ]
   Non-VA psychotherapy, psychiatric crisis services, and psychotropic medications
2. VA Service Use Form [ Time Frame: Baseline to 18 months ]
   VA mental health service use and psychotropic medications
3. Credibility Expectancy Questionnaire (CEQ) [ Time Frame: Baseline to 18 months ]
   Total score (range = 1 - 7, higher is better)
4. Client Satisfaction Questionnaire (CSQ) [ Time Frame: Post-treatment (4 months in PE + SRM, 12 months in DBT + DBT PE) ]
   Total score (range = 8 - 32, higher is better)
5. Dissociative Experiences Scale - Taxon (DES-T) [ Time Frame: Baseline to 18 months ]
   Total score (range = 0 - 80, higher is worse)
6. Trauma-Related Shame Inventory (TRSI) [ Time Frame: Baseline to 18 months ]
   Total score (range = 0 - 72, higher is worse)
7. Self-Compassion Scale (SCS) [ Time Frame: Baseline to 18 months ]
   Total score (range = 1 - 5, higher is better)
8. Borderline Symptom List - Behavioral Supplement (BSL-BS) [ Time Frame: Baseline to 18 months ]
   Total score (range = 0 - 44, higher is worse)
9. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Baseline to 18 months ]
   Total severity score (range = 0 - 80, higher is worse)
10. Post-Traumatic Cognitions Inventory-9 (PTCI-9) [ Time Frame: Baseline to 18 months ]
    Total score (range = 9 to 63, higher is worse)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Melanie S Harned, PhD; (206) 277-3650; melanie.harned@va.gov

Contact: John C Fortney, PhD; (206) 764-2821; John.Fortney@va.gov

Locations

United States, Minnesota

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States, 55417-2309

Contact: Lindsay Andrews-Wiebusch, PhD 612-629-7656 Lindsay.Andrews-Wiebusch@va.gov

Contact: Laura A Meis, PhD (612) 467-4516 laura.meis@va.gov

Sub-Investigator: Laura A. Meis, PhD

United States, North Carolina

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705-3875

Contact: Elizabeth E Van Voorhees, PhD 919-286-0411 ext 6435 Elizabeth.VanVoorhees@va.gov

Contact: Charlotte Ready, PhD (919) 286-0411 ext 177062 Charlotte.Ready@va.gov

Sub-Investigator: Elizabeth E Van Voorhees, PhD

United States, Washington

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

Seattle, Washington, United States, 98108-1532

Contact: Melanie S Harned, PhD 206-277-3650 melanie.harned@va.gov

Contact: John C Fortney, PhD (206) 764-2821 John.Fortney@va.gov

Principal Investigator: Melanie S Harned, PhD

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Melanie S Harned, PhD; VA Puget Sound Health Care System Seattle Division, Seattle, WA

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT05974631
• Other Study ID Numbers: SDR 22-185
• First Posted: August 3, 2023
• Last Update Posted: April 29, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified, anonymized data that underlie results in a publication may be shared.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

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

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders