xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05974631</url>
    </required_header>
    <id_info>
      <org_study_id>SDR 22-185</org_study_id>
      <nct_id>NCT05974631</nct_id>
    </id_info>
    <brief_title>Evaluating Treatments for Suicidal Veterans With PTSD</brief_title>
    <official_title>A Hybrid Effectiveness-Implementation Trial of Treatments for Veterans With PTSD at Elevated Acute Risk for Suicide</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VA Office of Research and Development</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Posttraumatic Stress Disorder (PTSD) is a significant driver of suicide risk among Veterans,&#xD;
        but there is a critical knowledge gap about how to treat PTSD among people at elevated risk&#xD;
        for suicide. Although evidence-based treatments for PTSD reduce suicide risk, Veterans at&#xD;
        high risk for suicidal behavior rarely receive these potentially life-saving treatments.&#xD;
        Prior research suggests that a treatment that combines Dialectical Behavior Therapy (DBT)&#xD;
        with the DBT Prolonged Exposure protocol (DBT PE) for PTSD improves both PTSD and&#xD;
        suicide-related outcomes. This study will evaluate whether DBT + DBT PE improves these&#xD;
        outcomes more than Prolonged Exposure plus suicide risk management, the gold standard VA care&#xD;
        for this population. The proposed study will also examine factors that make it easier and&#xD;
        harder to implement these treatments in VA settings. The results will help to inform&#xD;
        treatment guidelines for this high-priority Veteran population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Posttraumatic stress disorder (PTSD) is a significant risk factor for suicide&#xD;
        among Veterans. Evidence-based psychotherapies (EBPs) for PTSD reduce suicide risk, but&#xD;
        Veterans at elevated acute risk for suicide, such as those who have engaged in self-directed&#xD;
        violence (SDV), rarely receive these treatments. This is largely due to the historical&#xD;
        exclusion of high-risk individuals from PTSD treatment trials, which has resulted in a lack&#xD;
        of evidence-based guidance about indicated treatments for this population. Without such&#xD;
        guidance, clinicians are often reluctant to use EBPs for PTSD with suicidal individuals. A&#xD;
        treatment that combines Dialectical Behavior Therapy (DBT), a suicide-focused EBP, with the&#xD;
        DBT Prolonged Exposure (DBT PE) protocol for PTSD has been developed for this high-risk&#xD;
        population and shows promise in reducing both SDV and PTSD while being feasible, acceptable,&#xD;
        and safe to deliver. However, a large-scale randomized controlled trial (RCT) is needed. This&#xD;
        study will compare the effectiveness of DBT + DBT PE to the current VHA gold standard of care&#xD;
        for this population, Prolonged Exposure therapy augmented with suicide risk management (PE +&#xD;
        SRM), while also examining the potential for implementation of both interventions in VHA.&#xD;
  &#xD;
        Significance: There is a critical gap in knowledge about how to treat PTSD among individuals&#xD;
        at high risk for suicidal behavior. As a result, VA/DoD Clinical Practice Guidelines do not&#xD;
        specify indicated treatment strategies for this population. Experts have recommended two&#xD;
        approaches to facilitate the safe and effective use of EBPs for PTSD with individuals at&#xD;
        elevated acute suicide risk, including combining these treatments with suicide-focused EBPs&#xD;
        or augmenting them with suicide risk management strategies. This project will help to fill&#xD;
        this critical gap by rigorously evaluating these two approaches among Veterans with SDV. The&#xD;
        results will provide important information to inform guidelines about indicated treatments&#xD;
        for this high-risk population.&#xD;
  &#xD;
        Innovativeness: This will be the first large-scale RCT to evaluate treatments for PTSD among&#xD;
        Veterans who have engaged in SDV, an HSR&amp;D high priority group. The DBT + DBT PE intervention&#xD;
        is the first treatment designed to address both SDV and PTSD, and results will indicate if&#xD;
        this novel treatment improves outcomes compared to the current VHA gold standard of care. To&#xD;
        facilitate more rapid implementation of these findings into clinical practice, implementation&#xD;
        barriers and facilitators for both treatments will also be evaluated.&#xD;
  &#xD;
        Specific Aims: This study will randomize 200 Veterans with PTSD, recent and repeated SDV,&#xD;
        current suicidal ideation, and emotion dysregulation to DBT + DBT PE (intervention) or PE +&#xD;
        SRM (control). Aim 1 will test the hypothesis that DBT + DBT PE will be superior to PE + SRM&#xD;
        in improving clinical outcomes and engagement in trauma-focused treatment. Exploratory&#xD;
        analyses will examine Veteran characteristics that may predict better engagement and outcomes&#xD;
        in DBT + DBT PE versus PE + SRM. Aim 2 will examine barriers and facilitators to&#xD;
        implementation of both treatments.&#xD;
  &#xD;
        Methods: This is a multi-site hybrid type 1 effectiveness-implementation trial. Veterans will&#xD;
        be treated in outpatient settings at three VA sites and assessed at 5 points over 18 months.&#xD;
        A mixed-methods approach will be used to evaluate barriers and facilitators to&#xD;
        implementation, including conducting interviews with 45 key stakeholders (Veterans,&#xD;
        providers, and leadership).&#xD;
  &#xD;
        Primary Outcomes/Endpoints: Primary outcomes will be reductions in SDV episodes at 18-month&#xD;
        follow-up and reductions in PTSD severity at post-treatment.&#xD;
  &#xD;
        Implementation/Next Steps: This project will provide much-needed information about how to&#xD;
        safely and effectively treat PTSD among Veterans at elevated acute risk for suicide. If one&#xD;
        or both treatments are found effective, Aim 2 will provide vital information about how to&#xD;
        maximize future implementation success. Future implementation activities would be coordinated&#xD;
        with the investigators' national operational partners.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 1, 2024</start_date>
    <completion_date type="Anticipated">July 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>2-arm randomized clinical trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Outcome assessors will be masked to participants' treatment condition</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Number of self-directed violence episodes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Total Severity Score (range = 0 - 200, higher is worse)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Beck Scale for Suicide Ideation (BSSI)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Total Score (range = 0 - 38, higher is worse)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief Symptom Inventory (BSI)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Global Severity Index (range = 0 to 4, higher is worse)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difficulties in Emotion Regulation Scale-16 (DERS-16)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Total Score (range = 16 - 80, higher is worse)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>General Disability Score (range = 12 - 60, higher is worse)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Injurious Thoughts and Behaviors Interview Revised Short Form (SITBI-R-SF)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Non-suicidal self-injury frequency and remission; Suicide attempt frequency and remission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>PTSD diagnostic status</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Treatment History Interview (THI)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Non-VA psychotherapy, psychiatric crisis services, and psychotropic medications</description>
    </other_outcome>
    <other_outcome>
      <measure>VA Service Use Form</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>VA mental health service use and psychotropic medications</description>
    </other_outcome>
    <other_outcome>
      <measure>Credibility Expectancy Questionnaire (CEQ)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Total score (range = 1 - 7, higher is better)</description>
    </other_outcome>
    <other_outcome>
      <measure>Client Satisfaction Questionnaire (CSQ)</measure>
      <time_frame>Post-treatment (4 months in PE + SRM, 12 months in DBT + DBT PE)</time_frame>
      <description>Total score (range = 8 - 32, higher is better)</description>
    </other_outcome>
    <other_outcome>
      <measure>Dissociative Experiences Scale - Taxon (DES-T)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Total score (range = 0 - 80, higher is worse)</description>
    </other_outcome>
    <other_outcome>
      <measure>Trauma-Related Shame Inventory (TRSI)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Total score (range = 0 - 72, higher is worse)</description>
    </other_outcome>
    <other_outcome>
      <measure>Self-Compassion Scale (SCS)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Total score (range = 1 - 5, higher is better)</description>
    </other_outcome>
    <other_outcome>
      <measure>Borderline Symptom List - Behavioral Supplement (BSL-BS)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Total score (range = 0 - 44, higher is worse)</description>
    </other_outcome>
    <other_outcome>
      <measure>PTSD Checklist for DSM-5 (PCL-5)</measure>
      <time_frame>Every other week during PE or DBT PE, an average of 12 weeks</time_frame>
      <description>Total severity score (range = 0 - 80, higher is worse)</description>
    </other_outcome>
    <other_outcome>
      <measure>Post-Traumatic Cognitions Inventory-9 (PTCI-9)</measure>
      <time_frame>Baseline to 18 months</time_frame>
      <description>Total score (range = 9 to 63, higher is worse)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Self-directed Violence</condition>
    <condition>Post-traumatic Stress Disorder (PTSD)</condition>
    <arm_group>
      <arm_group_label>DBT + DBT PE</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This condition combines one year of standard Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure (DBT PE) protocol for PTSD.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PE + SRM</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This condition provides up to 18 sessions of Prolonged Exposure therapy (PE) for PTSD augmented with suicide risk management (SRM).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Dialectical Behavior Therapy</intervention_name>
      <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>
      <arm_group_label>DBT + DBT PE</arm_group_label>
      <other_name>DBT</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Dialectical Behavior Therapy Prolonged Exposure protocol</intervention_name>
      <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>
      <arm_group_label>DBT + DBT PE</arm_group_label>
      <other_name>DBT PE</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Prolonged Exposure therapy</intervention_name>
      <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>
      <arm_group_label>PE + SRM</arm_group_label>
      <other_name>PE</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Suicide risk management</intervention_name>
      <description>Standard VA suicide risk management procedures, including comprehensive suicide risk assessment and safety planning.</description>
      <arm_group_label>PE + SRM</arm_group_label>
      <other_name>SRM</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  PTSD&#xD;
  &#xD;
            -  Recent and repeated self-directed violence&#xD;
  &#xD;
            -  Current suicidal ideation&#xD;
  &#xD;
            -  Emotion dysregulation&#xD;
  &#xD;
            -  Veteran eligible for VHA mental health care at participating site (Seattle,&#xD;
               Minneapolis, and Durham VAs)&#xD;
  &#xD;
            -  Age 18+&#xD;
  &#xD;
            -  Willing to participate in all study activities&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to maintain safety independently&#xD;
  &#xD;
            -  Currently engaged in and/or recent (past year) history of receiving a sufficient dose&#xD;
               of DBT or PE&#xD;
  &#xD;
            -  Plan to move away or be unavailable for &gt;4 weeks in the next 18 months&#xD;
  &#xD;
            -  Unable to sufficiently comprehend study procedures due to lack of English proficiency&#xD;
               or moderate to severe cognitive impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Melanie S Harned, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>VA Puget Sound Health Care System Seattle Division, Seattle, WA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Melanie S Harned, PhD</last_name>
      <phone>(206) 277-3650</phone>
      <email>melanie.harned@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>John C Fortney, PhD</last_name>
      <phone>(206) 764-2821</phone>
      <email>John.Fortney@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Minneapolis VA Health Care System, Minneapolis, MN</name>
        <address>
          <city>Minneapolis</city>
          <state>Minnesota</state>
          <zip>55417-2309</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lindsay Andrews-Wiebusch, PhD</last_name>
        <phone>612-629-7656</phone>
        <email>Lindsay.Andrews-Wiebusch@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Laura Meis, PhD</last_name>
        <phone>6124674516</phone>
        <email>Laura.Meis@va.gov</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Durham VA Medical Center, Durham, NC</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27705-3875</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Elizabeth Van Voorhees, PhD</last_name>
        <phone>919-824-5529</phone>
        <email>Elizabeth.Vanvoorhees@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Charlotte Ready, PhD</last_name>
        <phone>9192860411</phone>
        <phone_ext>177062</phone_ext>
        <email>Charlotte.Ready@va.gov</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>VA Puget Sound Health Care System Seattle Division, Seattle, WA</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98108-1532</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Melanie S Harned, PhD</last_name>
        <phone>206-277-3650</phone>
        <email>melanie.harned@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>John C Fortney, PhD</last_name>
        <phone>(206) 764-2821</phone>
        <email>John.Fortney@va.gov</email>
      </contact_backup>
      <investigator>
        <last_name>Melanie S Harned, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Stress Disorders, Post-Traumatic</keyword>
    <keyword>Suicide</keyword>
    <keyword>Self-Injurious Behavior</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stress Disorders, Traumatic</mesh_term>
      <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified, anonymized data that underlie results in a publication may be shared.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Starting after publication of relevant data</ipd_time_frame>
      <ipd_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.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05974631
  org study id: SDR 22-185
  nct id: NCT05974631
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 2-arm randomized clinical trial
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Outcome assessors will be masked to participants' treatment condition
  measure: Self-Injurious Thoughts and Behaviors Interview - Revised Short Form (SITBI-R-SF)
  time frame: Baseline to 18 months
  description: Number of self-directed violence episodes
  measure: Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
  time frame: Baseline to 18 months
  description: Total Severity Score (range = 0 - 200, higher is worse)
  measure: Beck Scale for Suicide Ideation (BSSI)
  time frame: Baseline to 18 months
  description: Total Score (range = 0 - 38, higher is worse)
  measure: Brief Symptom Inventory (BSI)
  time frame: Baseline to 18 months
  description: Global Severity Index (range = 0 to 4, higher is worse)
  measure: Difficulties in Emotion Regulation Scale-16 (DERS-16)
  time frame: Baseline to 18 months
  description: Total Score (range = 16 - 80, higher is worse)
  measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
  time frame: Baseline to 18 months
  description: General Disability Score (range = 12 - 60, higher is worse)
  measure: Self-Injurious Thoughts and Behaviors Interview Revised Short Form (SITBI-R-SF)
  time frame: Baseline to 18 months
  description: Non-suicidal self-injury frequency and remission; Suicide attempt frequency and remission
  measure: Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
  time frame: Baseline to 18 months
  description: PTSD diagnostic status
  measure: Treatment History Interview (THI)
  time frame: Baseline to 18 months
  description: Non-VA psychotherapy, psychiatric crisis services, and psychotropic medications
  measure: VA Service Use Form
  time frame: Baseline to 18 months
  description: VA mental health service use and psychotropic medications
  measure: Credibility Expectancy Questionnaire (CEQ)
  time frame: Baseline to 18 months
  description: Total score (range = 1 - 7, higher is better)
  measure: Client Satisfaction Questionnaire (CSQ)
  time frame: Post-treatment (4 months in PE + SRM, 12 months in DBT + DBT PE)
  description: Total score (range = 8 - 32, higher is better)
  measure: Dissociative Experiences Scale - Taxon (DES-T)
  time frame: Baseline to 18 months
  description: Total score (range = 0 - 80, higher is worse)
  measure: Trauma-Related Shame Inventory (TRSI)
  time frame: Baseline to 18 months
  description: Total score (range = 0 - 72, higher is worse)
  measure: Self-Compassion Scale (SCS)
  time frame: Baseline to 18 months
  description: Total score (range = 1 - 5, higher is better)
  measure: Borderline Symptom List - Behavioral Supplement (BSL-BS)
  time frame: Baseline to 18 months
  description: Total score (range = 0 - 44, higher is worse)
  measure: PTSD Checklist for DSM-5 (PCL-5)
  time frame: Every other week during PE or DBT PE, an average of 12 weeks
  description: Total severity score (range = 0 - 80, higher is worse)
  measure: Post-Traumatic Cognitions Inventory-9 (PTCI-9)
  time frame: Baseline to 18 months
  description: Total score (range = 9 to 63, higher is worse)
  arm group label: DBT + DBT PE
  arm group type: Experimental
  description: This condition combines one year of standard Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure (DBT PE) protocol for PTSD.
  arm group label: PE + SRM
  arm group type: Active Comparator
  description: This condition provides up to 18 sessions of Prolonged Exposure therapy (PE) for PTSD augmented with suicide risk management (SRM).
  intervention type: Behavioral
  intervention name: Dialectical Behavior Therapy
  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).
  arm group label: DBT + DBT PE
  other name: DBT
  intervention type: Behavioral
  intervention name: Dialectical Behavior Therapy Prolonged Exposure protocol
  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).
  arm group label: DBT + DBT PE
  other name: DBT PE
  intervention type: Behavioral
  intervention name: Prolonged Exposure therapy
  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.
  arm group label: PE + SRM
  other name: PE
  intervention type: Behavioral
  intervention name: Suicide risk management
  description: Standard VA suicide risk management procedures, including comprehensive suicide risk assessment and safety planning.
  arm group label: PE + SRM
  other name: SRM
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Melanie S Harned, PhD
  role: Principal Investigator
  affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
  last name: Melanie S Harned, PhD
  phone: (206) 277-3650
  email: melanie.harned@va.gov
  last name: John C Fortney, PhD
  phone: (206) 764-2821
  email: John.Fortney@va.gov
  facility: 
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  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stress Disorders, Traumatic
  mesh term: Stress Disorders, Post-Traumatic
  sharing ipd: Yes
  ipd description: De-identified, anonymized data that underlie results in a publication may be shared.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Analytic Code
  ipd time frame: Starting after publication of relevant data
  ipd 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.