<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/NCT03777553</url>
  </required_header>
  <id_info>
    <org_study_id>D1298-W-1</org_study_id>
    <nct_id>NCT03777553</nct_id>
  </id_info>
  <brief_title>Narrative Exposure Therapy (NET)</brief_title>
  <acronym>NET</acronym>
  <official_title>Narrative Exposure Therapy for Justice-Involved Veterans (D1298-W)</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>No</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>
      The purpose of this study is to learn more about Narrative Exposure Therapy for Justice&#xD;
      Involved Veterans. This pilot study will examine the feasibility of this intervention in a&#xD;
      justice-involved veteran population, and will see whether the intervention needs to be&#xD;
      tailored to best meet their needs. The investigators will examine whether the intervention&#xD;
      impacts key clinical outcomes, including posttraumatic stress disorder symptoms, as well as&#xD;
      on measures of moral injury, anger, depression, suicidality, and aggression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall objective of this application is to gather data on the use of Narrative Exposure&#xD;
      Therapy for Justice Involved Veterans (VETNET) in a pilot sample of justice-involved Veterans&#xD;
      with PTSD, with a particular focus on obtaining data on feasibility and acceptability of the&#xD;
      intervention in a justice-involved veteran population, and determining what further&#xD;
      adaptations are needed to tailor this intervention to justice-involved Veterans (JIV). The&#xD;
      investigators are also interested in evaluating whether the intervention has the potential to&#xD;
      have an effect on key clinical outcomes, including posttraumatic stress disorder (PTSD)&#xD;
      symptoms, as well as on measures of moral injury, anger, depression, suicidality, and&#xD;
      aggression.&#xD;
&#xD;
      The following Specific Aims have been developed for this project:&#xD;
&#xD;
      Aim 1: Evaluate study feasibility and treatment delivery procedures of Narrative Exposure&#xD;
      Therapy for Justice Involved Veterans (VETNET) in justice-involved Veterans (JIV) with PTSD.&#xD;
      Data gathered will include recruitment rates, drop-out rates, adverse event frequency and&#xD;
      severity, and participant engagement in treatment. As necessary, identify further adaptations&#xD;
      that are needed to tailor this intervention specifically to JIV.&#xD;
&#xD;
      Aim 2: Evaluate the impact of VETNET on PTSD symptoms, as well as on related outcomes&#xD;
      including moral injury, anger, depression, suicidality, and aggression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2019</start_date>
  <completion_date type="Actual">February 24, 2021</completion_date>
  <primary_completion_date type="Actual">February 24, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a single group pre/post trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PTSD Checklist for the DSM-5 (PCL-5)</measure>
    <time_frame>Change in total score from baseline to end of treatment (approximately 10-12 weeks)</time_frame>
    <description>On the PCL-5 participants first report an autobiographical narrative of a trauma, and subsequently rate how bothered they were by each symptom (0 [not at all] - 4 [extremely]) for all DSM-V PTSD symptoms within the past week. Total score range is 0 to 80, with higher scores reflecting greater symptomatology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dimensions of Anger Reactions (DAR)</measure>
    <time_frame>Change in total score from baseline to end of treatment (approximately 10-12 weeks)</time_frame>
    <description>The DAR is a 7-item scale measuring the frequency, duration, and behavioral response to anger, and anger-related functional impairment on social relationships, health, and work. It was found to have concurrent and discriminant validity, and to correlate highly with measures of functional impairment, in a large sample of treatment-seeking soldiers who had served in Iraq or Afghanistan. Score range is from 0-56, with higher score reflecting greater problems with anger.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Appetitive Aggression Scale (AAS)</measure>
    <time_frame>Change in total score from baseline to end of treatment (approximately 10-12 weeks)</time_frame>
    <description>This scale has two parts. Part 1 is a 17-item scale that asked participants to mark whether they have engaged in or witness specific violent acts. Fifteen of these items measure acts that could reflect appetitive aggression (e.g. &quot;.made another person scream in pain&quot;), and two are more clearly reactive (e.g. &quot;...defended yourself in a fight&quot;). If a participant endorses having engaged in any of the 15 potentially appetitive aggressive behaviors, then Part 2 will be administered. Part 2 is a 19-item scale that asks participants to rate their perceptions of aggression on a 5-point Likert scale ranging from 0 (disagree) to 4 (agree). Part 2 of the scale has been demonstrated to have acceptable reliability, and has been shown to measure a construct distinct from other conceptualizations of aggression. Total score range is 0 to 76, with higher score reflecting greater appetitive aggression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory (BDI-2)</measure>
    <time_frame>Change in total score from baseline to end of treatment (approximately 10-12 weeks)</time_frame>
    <description>The BDI-2 is a 21-item scale that evaluates symptoms of depression. Total score range is from 0 to 63, with higher scores indicating greater depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Moral Injury Events Scale (MIES)</measure>
    <time_frame>Change in total score from baseline to end of treatment (approximately 10-12 weeks)</time_frame>
    <description>The MIES is an 11-item scale that measures moral injury associated with experiences during military service. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11 to 66, with higher scores reflecting greater moral injury.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Conflict Tactics Scales (CTS2)</measure>
    <time_frame>Change in total score from baseline to end of treatment (approximately 10-12 weeks)</time_frame>
    <description>The CTS2 includes 78 items measuring the use of psychological and physical attacks by the participant, as well as the experience of such attacks. Participants answer how often these behaviors were perpetrated by or against them within a specified time period: 0 (never); 1 (once); 2 (twice); 3 (3-5 times); 4 (6-10 times); 5 (11-20 times); 6 (more than 20 times). The original CTS2 instructions will be modified to more appropriately reflect the goals of this study: 1) the target of the behavior will be expanded from &quot;partner&quot; to &quot;anyone&quot;; and 2) the time frame of the response will be reduced from one year to three months to detect potential changes associated with treatment. The CTS2 includes the following subscales: Negotiation, Psychological Aggression, Physical Assault, Sexual Coercion, and Injury. Physical Assault scores range from 0 to 72, with higher scores reflecting higher frequency of assaultive behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trauma-Related Guilt Index (TRGI)</measure>
    <time_frame>Change in total score from baseline to end of treatment (approximately 10-12 weeks)</time_frame>
    <description>Guided by appraisal theories of emotion, the 32-item TRGI is an index of guilt associated with the experience of trauma. Participants rate statements on a 5-point scale ranging from extremely true/extremely guilty (4) to not at all true/not guilty at all (0). Total scores range from 0 to 128, with higher scores reflecting greater trauma-related guilt.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interpersonal Needs Questionnaire (INQ)</measure>
    <time_frame>Change in total score from baseline to end of treatment (approximately 10-12 weeks)</time_frame>
    <description>Based upon the Interpersonal Theory of Suicide (Joiner Jr et al., 2009), the INQ measures two proximal causes of the desire for suicide: Thwarted belongingness and Perceived burdensomeness. Participants rate each of the 15 items on a scale of 1 (not at all true for me) to 7 (very true for me). Total scores range from 15 to 105, with greater scores reflecting higher levels of suicide-related cognitions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>VETNET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Narrative Exposure Therapy for Justice-Involved Veterans</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Narrative Exposure Therapy for Justice-Involved Veterans</intervention_name>
    <description>Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.</description>
    <arm_group_label>VETNET</arm_group_label>
    <other_name>VETNET</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is a veteran;&#xD;
&#xD;
          -  Recent justice involvement including current probation, parole, or house arrest, or&#xD;
             having been released from jail or prison within the past 1 year;&#xD;
&#xD;
          -  Meets current criteria for PTSD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently incarcerated;&#xD;
&#xD;
          -  Current, active psychosis;&#xD;
&#xD;
          -  Is at imminent risk for suicide or homicide warranting immediate intervention;&#xD;
&#xD;
          -  Substance abuse that is severe enough to prevent full engagement in the study&#xD;
             protocol;&#xD;
&#xD;
          -  Concurrent trauma-focused psychotherapy including Prolonged Exposure Therapy,&#xD;
             Cognitive Processing Therapy, or EMDR;&#xD;
&#xD;
          -  Is unable to unwilling to complete study procedures.&#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>Elizabeth E Van Voorhees, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durham VA Medical Center, Durham, NC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Durham VA Medical Center, Durham, NC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>posttraumatic stress disorder</keyword>
  <keyword>criminal justice</keyword>
  <keyword>Veterans</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>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 5, 2022</submitted>
    <returned>February 3, 2023</returned>
    <submitted>March 28, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03777553
org study id: D1298-W-1
nct id: NCT03777553
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to learn more about Narrative Exposure Therapy for Justice
      Involved Veterans. This pilot study will examine the feasibility of this intervention in a
      justice-involved veteran population, and will see whether the intervention needs to be
      tailored to best meet their needs. The investigators will examine whether the intervention
      impacts key clinical outcomes, including posttraumatic stress disorder symptoms, as well as
      on measures of moral injury, anger, depression, suicidality, and aggression.
The overall objective of this application is to gather data on the use of Narrative Exposure
      Therapy for Justice Involved Veterans (VETNET) in a pilot sample of justice-involved Veterans
      with PTSD, with a particular focus on obtaining data on feasibility and acceptability of the
      intervention in a justice-involved veteran population, and determining what further
      adaptations are needed to tailor this intervention to justice-involved Veterans (JIV). The
      investigators are also interested in evaluating whether the intervention has the potential to
      have an effect on key clinical outcomes, including posttraumatic stress disorder (PTSD)
      symptoms, as well as on measures of moral injury, anger, depression, suicidality, and
      aggression.

      The following Specific Aims have been developed for this project:

      Aim 1: Evaluate study feasibility and treatment delivery procedures of Narrative Exposure
      Therapy for Justice Involved Veterans (VETNET) in justice-involved Veterans (JIV) with PTSD.
      Data gathered will include recruitment rates, drop-out rates, adverse event frequency and
      severity, and participant engagement in treatment. As necessary, identify further adaptations
      that are needed to tailor this intervention specifically to JIV.

      Aim 2: Evaluate the impact of VETNET on PTSD symptoms, as well as on related outcomes
      including moral injury, anger, depression, suicidality, and aggression.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a single group pre/post trial.
primary purpose: Treatment
masking: None (Open Label)
measure: PTSD Checklist for the DSM-5 (PCL-5)
time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks)
description: On the PCL-5 participants first report an autobiographical narrative of a trauma, and subsequently rate how bothered they were by each symptom (0 [not at all] - 4 [extremely]) for all DSM-V PTSD symptoms within the past week. Total score range is 0 to 80, with higher scores reflecting greater symptomatology.
measure: Dimensions of Anger Reactions (DAR)
time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks)
description: The DAR is a 7-item scale measuring the frequency, duration, and behavioral response to anger, and anger-related functional impairment on social relationships, health, and work. It was found to have concurrent and discriminant validity, and to correlate highly with measures of functional impairment, in a large sample of treatment-seeking soldiers who had served in Iraq or Afghanistan. Score range is from 0-56, with higher score reflecting greater problems with anger.
measure: The Appetitive Aggression Scale (AAS)
time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks)
description: This scale has two parts. Part 1 is a 17-item scale that asked participants to mark whether they have engaged in or witness specific violent acts. Fifteen of these items measure acts that could reflect appetitive aggression (e.g. ".made another person scream in pain"), and two are more clearly reactive (e.g. "...defended yourself in a fight"). If a participant endorses having engaged in any of the 15 potentially appetitive aggressive behaviors, then Part 2 will be administered. Part 2 is a 19-item scale that asks participants to rate their perceptions of aggression on a 5-point Likert scale ranging from 0 (disagree) to 4 (agree). Part 2 of the scale has been demonstrated to have acceptable reliability, and has been shown to measure a construct distinct from other conceptualizations of aggression. Total score range is 0 to 76, with higher score reflecting greater appetitive aggression.
measure: Beck Depression Inventory (BDI-2)
time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks)
description: The BDI-2 is a 21-item scale that evaluates symptoms of depression. Total score range is from 0 to 63, with higher scores indicating greater depression.
measure: The Moral Injury Events Scale (MIES)
time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks)
description: The MIES is an 11-item scale that measures moral injury associated with experiences during military service. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11 to 66, with higher scores reflecting greater moral injury.
measure: Revised Conflict Tactics Scales (CTS2)
time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks)
description: The CTS2 includes 78 items measuring the use of psychological and physical attacks by the participant, as well as the experience of such attacks. Participants answer how often these behaviors were perpetrated by or against them within a specified time period: 0 (never); 1 (once); 2 (twice); 3 (3-5 times); 4 (6-10 times); 5 (11-20 times); 6 (more than 20 times). The original CTS2 instructions will be modified to more appropriately reflect the goals of this study: 1) the target of the behavior will be expanded from "partner" to "anyone"; and 2) the time frame of the response will be reduced from one year to three months to detect potential changes associated with treatment. The CTS2 includes the following subscales: Negotiation, Psychological Aggression, Physical Assault, Sexual Coercion, and Injury. Physical Assault scores range from 0 to 72, with higher scores reflecting higher frequency of assaultive behavior.
measure: Trauma-Related Guilt Index (TRGI)
time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks)
description: Guided by appraisal theories of emotion, the 32-item TRGI is an index of guilt associated with the experience of trauma. Participants rate statements on a 5-point scale ranging from extremely true/extremely guilty (4) to not at all true/not guilty at all (0). Total scores range from 0 to 128, with higher scores reflecting greater trauma-related guilt.
measure: Interpersonal Needs Questionnaire (INQ)
time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks)
description: Based upon the Interpersonal Theory of Suicide (Joiner Jr et al., 2009), the INQ measures two proximal causes of the desire for suicide: Thwarted belongingness and Perceived burdensomeness. Participants rate each of the 15 items on a scale of 1 (not at all true for me) to 7 (very true for me). Total scores range from 15 to 105, with greater scores reflecting higher levels of suicide-related cognitions.
arm group label: VETNET
arm group type: Experimental
description: Narrative Exposure Therapy for Justice-Involved Veterans
intervention type: Behavioral
intervention name: Narrative Exposure Therapy for Justice-Involved Veterans
description: Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
arm group label: VETNET
other name: VETNET
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth E Van Voorhees, PhD
role: Principal Investigator
affiliation: Durham VA Medical Center, Durham, NC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No
submitted: May 5, 2022
returned: February 3, 2023
submitted: March 28, 2023