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Evaluating Treatments for Suicidal Veterans With PTSD

Studies

Study First Submitted Date 2023-07-05
Study First Posted Date 2023-08-03
Last Update Posted Date 2023-08-03
Start Month Year February 1, 2024
Primary Completion Month Year April 30, 2027
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-08-03

Detailed Descriptions

Sequence: 20723837
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.

Facilities

Sequence: 200128906 Sequence: 200128907 Sequence: 200128908
Name Minneapolis VA Health Care System, Minneapolis, MN Name Durham VA Medical Center, Durham, NC Name VA Puget Sound Health Care System Seattle Division, Seattle, WA
City Minneapolis City Durham City Seattle
State Minnesota State North Carolina State Washington
Zip 55417-2309 Zip 27705-3875 Zip 98108-1532
Country United States Country United States Country United States

Facility Contacts

Sequence: 28108989 Sequence: 28108990 Sequence: 28108991 Sequence: 28108992 Sequence: 28108993 Sequence: 28108994
Facility Id 200128906 Facility Id 200128906 Facility Id 200128907 Facility Id 200128907 Facility Id 200128908 Facility Id 200128908
Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup
Name Lindsay Andrews-Wiebusch, PhD Name Laura Meis, PhD Name Elizabeth Van Voorhees, PhD Name Charlotte Ready, PhD Name Melanie S Harned, PhD Name John C Fortney, PhD
Email Lindsay.Andrews-Wiebusch@va.gov Email Laura.Meis@va.gov Email Elizabeth.Vanvoorhees@va.gov Email Charlotte.Ready@va.gov Email melanie.harned@va.gov Email John.Fortney@va.gov
Phone 612-629-7656 Phone 6124674516 Phone 919-824-5529 Phone 9192860411 Phone 206-277-3650 Phone (206) 764-2821
Phone Extension 177062

Facility Investigators

Sequence: 18334177
Facility Id 200128908
Role Principal Investigator
Name Melanie S Harned, PhD

Conditions

Sequence: 52176923 Sequence: 52176924
Name Self-directed Violence Name Post-traumatic Stress Disorder (PTSD)
Downcase Name self-directed violence Downcase Name post-traumatic stress disorder (ptsd)

Id Information

Sequence: 40162651
Id Source org_study_id
Id Value SDR 22-185

Countries

Sequence: 42573460
Name United States
Removed False

Design Groups

Sequence: 55599625 Sequence: 55599626
Group Type Experimental Group Type Active Comparator
Title DBT + DBT PE Title PE + SRM
Description This condition combines one year of standard Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure (DBT PE) protocol for PTSD. Description This condition provides up to 18 sessions of Prolonged Exposure therapy (PE) for PTSD augmented with suicide risk management (SRM).

Interventions

Sequence: 52491075 Sequence: 52491076 Sequence: 52491077 Sequence: 52491078
Intervention Type Behavioral Intervention Type Behavioral Intervention Type Behavioral Intervention Type Behavioral
Name Dialectical Behavior Therapy Name Dialectical Behavior Therapy Prolonged Exposure protocol Name Prolonged Exposure therapy Name Suicide risk management
Description 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). Description 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). Description 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. Description Standard VA suicide risk management procedures, including comprehensive suicide risk assessment and safety planning.

Keywords

Sequence: 79875861 Sequence: 79875862 Sequence: 79875863
Name Stress Disorders, Post-Traumatic Name Suicide Name Self-Injurious Behavior
Downcase Name stress disorders, post-traumatic Downcase Name suicide Downcase Name self-injurious behavior

Design Outcomes

Sequence: 177401748 Sequence: 177401749 Sequence: 177401750 Sequence: 177401751 Sequence: 177401752 Sequence: 177401753 Sequence: 177401754 Sequence: 177401755 Sequence: 177401756 Sequence: 177401757 Sequence: 177401758 Sequence: 177401759 Sequence: 177401760 Sequence: 177401761 Sequence: 177401762 Sequence: 177401763 Sequence: 177401764 Sequence: 177401765
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure Self-Injurious Thoughts and Behaviors Interview – Revised Short Form (SITBI-R-SF) Measure Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Measure Beck Scale for Suicide Ideation (BSSI) Measure Brief Symptom Inventory (BSI) Measure Difficulties in Emotion Regulation Scale-16 (DERS-16) Measure World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Measure Self-Injurious Thoughts and Behaviors Interview Revised Short Form (SITBI-R-SF) Measure Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Measure Treatment History Interview (THI) Measure VA Service Use Form Measure Credibility Expectancy Questionnaire (CEQ) Measure Client Satisfaction Questionnaire (CSQ) Measure Dissociative Experiences Scale – Taxon (DES-T) Measure Trauma-Related Shame Inventory (TRSI) Measure Self-Compassion Scale (SCS) Measure Borderline Symptom List – Behavioral Supplement (BSL-BS) Measure PTSD Checklist for DSM-5 (PCL-5) Measure Post-Traumatic Cognitions Inventory-9 (PTCI-9)
Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Post-treatment (4 months in PE + SRM, 12 months in DBT + DBT PE) Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Baseline to 18 months Time Frame Every other week during PE or DBT PE, an average of 12 weeks Time Frame Baseline to 18 months
Description Number of self-directed violence episodes Description Total Severity Score (range = 0 – 200, higher is worse) Description Total Score (range = 0 – 38, higher is worse) Description Global Severity Index (range = 0 to 4, higher is worse) Description Total Score (range = 16 – 80, higher is worse) Description General Disability Score (range = 12 – 60, higher is worse) Description Non-suicidal self-injury frequency and remission; Suicide attempt frequency and remission Description PTSD diagnostic status Description Non-VA psychotherapy, psychiatric crisis services, and psychotropic medications Description VA mental health service use and psychotropic medications Description Total score (range = 1 – 7, higher is better) Description Total score (range = 8 – 32, higher is better) Description Total score (range = 0 – 80, higher is worse) Description Total score (range = 0 – 72, higher is worse) Description Total score (range = 1 – 5, higher is better) Description Total score (range = 0 – 44, higher is worse) Description Total severity score (range = 0 – 80, higher is worse) Description Total score (range = 9 to 63, higher is worse)

Browse Conditions

Sequence: 193508400 Sequence: 193508401 Sequence: 193508402 Sequence: 193508403
Mesh Term Stress Disorders, Traumatic Mesh Term Stress Disorders, Post-Traumatic Mesh Term Trauma and Stressor Related Disorders Mesh Term Mental Disorders
Downcase Mesh Term stress disorders, traumatic Downcase Mesh Term stress disorders, post-traumatic Downcase Mesh Term trauma and stressor related disorders Downcase Mesh Term mental disorders
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48324373
Agency Class FED
Lead Or Collaborator lead
Name VA Office of Research and Development

Overall Officials

Sequence: 29288168
Role Principal Investigator
Name Melanie S Harned, PhD
Affiliation VA Puget Sound Health Care System Seattle Division, Seattle, WA

Central Contacts

Sequence: 12010313 Sequence: 12010314
Contact Type primary Contact Type backup
Name Melanie S Harned, PhD Name John C Fortney, PhD
Phone (206) 277-3650 Phone (206) 764-2821
Email melanie.harned@va.gov Email John.Fortney@va.gov
Role Contact Role Contact

Design Group Interventions

Sequence: 68157029 Sequence: 68157030 Sequence: 68157031 Sequence: 68157032
Design Group Id 55599625 Design Group Id 55599625 Design Group Id 55599626 Design Group Id 55599626
Intervention Id 52491075 Intervention Id 52491076 Intervention Id 52491077 Intervention Id 52491078

Eligibilities

Sequence: 30768595
Gender All
Minimum Age 18 Years
Maximum Age N/A
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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253930475
Number Of Facilities 3
Registered In Calendar Year 2023
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 6
Number Of Other Outcomes To Measure 10

Designs

Sequence: 30514755
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Masking Description Outcome assessors will be masked to participants' treatment condition
Intervention Model Description 2-arm randomized clinical trial
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26676612 Sequence: 26676613 Sequence: 26676614 Sequence: 26676615
Intervention Id 52491075 Intervention Id 52491076 Intervention Id 52491077 Intervention Id 52491078
Name DBT Name DBT PE Name PE Name SRM

Responsible Parties

Sequence: 28881056
Responsible Party Type Sponsor

Ipd Information Types

Sequence: 3334683 Sequence: 3334684 Sequence: 3334685
Name Study Protocol Name Statistical Analysis Plan (SAP) Name Analytic Code