- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05974631
Evaluating Treatments for Suicidal Veterans With PTSD
A Hybrid Effectiveness-Implementation Trial of Treatments for Veterans With PTSD at Elevated Acute Risk for Suicide
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melanie S Harned, PhD
- Phone Number: (206) 277-3650
- Email: melanie.harned@va.gov
Study Contact Backup
- Name: John C Fortney, PhD
- Phone Number: (206) 764-2821
- Email: John.Fortney@va.gov
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55417-2309
- Minneapolis VA Health Care System, Minneapolis, MN
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Contact:
- Laura A Meis, PhD
- Phone Number: (612) 467-4516
- Email: laura.meis@va.gov
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Contact:
- Lindsay Andrews-Wiebusch, PhD
- Phone Number: 612-629-7656
- Email: Lindsay.Andrews-Wiebusch@va.gov
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Sub-Investigator:
- Laura A. Meis, PhD
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North Carolina
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Durham, North Carolina, United States, 27705-3875
- Durham VA Medical Center, Durham, NC
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Contact:
- Elizabeth E Van Voorhees, PhD
- Phone Number: 6435 919-286-0411
- Email: Elizabeth.VanVoorhees@va.gov
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Contact:
- Charlotte Ready, PhD
- Phone Number: 177062 (919) 286-0411
- Email: Charlotte.Ready@va.gov
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Sub-Investigator:
- Elizabeth E Van Voorhees, PhD
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Washington
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Seattle, Washington, United States, 98108-1532
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
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Contact:
- John C Fortney, PhD
- Phone Number: (206) 764-2821
- Email: John.Fortney@va.gov
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Contact:
- Melanie S Harned, PhD
- Phone Number: 206-277-3650
- Email: melanie.harned@va.gov
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Principal Investigator:
- Melanie S Harned, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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 Names:
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 Names:
|
Active Comparator: PE + SRM
This condition provides up to 18 sessions of Prolonged Exposure therapy (PE) for PTSD augmented with suicide risk management (SRM).
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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 Names:
Standard VA suicide risk management procedures, including comprehensive suicide risk assessment and safety planning.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF)
Time Frame: Baseline to 18 months
|
Number of self-directed violence episodes
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Baseline to 18 months
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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)
|
Baseline to 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Symptom Inventory (BSI)
Time Frame: Baseline to 18 months
|
Global Severity Index (range = 0 to 4, higher is worse)
|
Baseline to 18 months
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Difficulties in Emotion Regulation Scale-16 (DERS-16)
Time Frame: Baseline to 18 months
|
Total Score (range = 16 - 80, higher is worse)
|
Baseline to 18 months
|
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)
|
Baseline to 18 months
|
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
|
Baseline to 18 months
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Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Time Frame: Baseline to 18 months
|
PTSD diagnostic status
|
Baseline to 18 months
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Columbia - Suicide Severity Rating Scale (C-SSRS), Suicide Ideation subscales
Time Frame: Baseline to 18 months
|
Total Score (range = 0 - 5, higher is worse)
|
Baseline to 18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment History Interview (THI)
Time Frame: Baseline to 18 months
|
Non-VA psychotherapy, psychiatric crisis services, and psychotropic medications
|
Baseline to 18 months
|
VA Service Use Form
Time Frame: Baseline to 18 months
|
VA mental health service use and psychotropic medications
|
Baseline to 18 months
|
Credibility Expectancy Questionnaire (CEQ)
Time Frame: Baseline to 18 months
|
Total score (range = 1 - 7, higher is better)
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Baseline to 18 months
|
Client Satisfaction Questionnaire (CSQ)
Time Frame: Post-treatment (4 months in PE + SRM, 12 months in DBT + DBT PE)
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Total score (range = 8 - 32, higher is better)
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Post-treatment (4 months in PE + SRM, 12 months in DBT + DBT PE)
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Dissociative Experiences Scale - Taxon (DES-T)
Time Frame: Baseline to 18 months
|
Total score (range = 0 - 80, higher is worse)
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Baseline to 18 months
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Trauma-Related Shame Inventory (TRSI)
Time Frame: Baseline to 18 months
|
Total score (range = 0 - 72, higher is worse)
|
Baseline to 18 months
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Self-Compassion Scale (SCS)
Time Frame: Baseline to 18 months
|
Total score (range = 1 - 5, higher is better)
|
Baseline to 18 months
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Borderline Symptom List - Behavioral Supplement (BSL-BS)
Time Frame: Baseline to 18 months
|
Total score (range = 0 - 44, higher is worse)
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Baseline to 18 months
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Post-Traumatic Cognitions Inventory-9 (PTCI-9)
Time Frame: Baseline to 18 months
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Total score (range = 9 to 63, higher is worse)
|
Baseline to 18 months
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PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Baseline to 18 months
|
Total severity score (range = 0 - 80, higher is worse)
|
Baseline to 18 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Melanie S Harned, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDR 22-185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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