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/NCT05969080</url>
    </required_header>
    <id_info>
      <org_study_id>D4803-W</org_study_id>
      <secondary_id>1745432</secondary_id>
      <nct_id>NCT05969080</nct_id>
    </id_info>
    <brief_title>Self-Injury Treatment and Recovery in Veterans</brief_title>
    <acronym>STRIVe</acronym>
    <official_title>A Brief Intervention to Reduce Nonsuicidal Self-Injury and Improve Functioning in Veterans</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>
        Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue&#xD;
        without suicidal intent and for purposes that are not socially sanctioned. While NSSI has&#xD;
        been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is&#xD;
        approximately three times higher than the general population. Moreover, NSSI is associated&#xD;
        with increased risk for violence, psychiatric distress, and marked impairment in psychosocial&#xD;
        functioning. Even though NSSI is distinct from suicidal behaviors in several important ways,&#xD;
        NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project&#xD;
        is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to&#xD;
        reduce psychosocial impairment and NSSI behaviors in Veterans.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue&#xD;
        without suicidal intent and for purposes that are not socially sanctioned. While NSSI has&#xD;
        been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is&#xD;
        approximately three times higher than the general population. Moreover, NSSI is associated&#xD;
        with increased risk for violence, psychiatric distress, and marked impairment in psychosocial&#xD;
        functioning. Even though NSSI is distinct from suicidal behaviors in several important ways,&#xD;
        NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project&#xD;
        is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to&#xD;
        reduce psychosocial impairment and NSSI behaviors in Veterans. This treatment, known as the&#xD;
        Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to&#xD;
        replace NSSI with behaviors that improve psychoso ial functioning. A core component of T-SIB&#xD;
        is functional assessment that identifies the antecedents and consequences of NSSI. This&#xD;
        project will enhance T-SIB by using ecological momentary assessment (EMA) to conduct NSSI&#xD;
        functional assessment in-vivo. EMA reduces retrospective recall bias and can increase&#xD;
        engagement with therapeutic goals.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">March 1, 2025</start_date>
    <completion_date type="Anticipated">March 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">January 1, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility as measured by number of participants enrolled</measure>
      <time_frame>2 years after study enrollment begins</time_frame>
      <description>All participants (N = 40) will need to be enrolled by the end of the second year of the study to consider the recruitment benchmark met.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility as measured rate of retention</measure>
      <time_frame>End of treatment, about nine weeks after beginning the study</time_frame>
      <description>Retention will be measured by the number of participants who complete at least six T-SIB treatment sessions. This benchmark will be considered meet if at least 2/3 of the 20 participants randomized to T-SIB complete at least 6 treatment sessions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants who report satisfaction with the T-SIB treatment</measure>
      <time_frame>End of treatment, about nine weeks after beginning the study</time_frame>
      <description>Participant satisfaction will be measured with the Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, which higher scores indicating higher satisfaction. A cut score of 24 will be used such that if the CSQ-8 score exceeds 24, that patient is deemed to have been satisfied with the treatment.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Self-Injurious Behavior</condition>
    <arm_group>
      <arm_group_label>T-SIB</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants randomized to the Treatment for Self-Injurious Behaviors (T-SIB) condition will receive nine sessions of T-SIB.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment As Usual</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants randomized to the TAU condition will be provided with referrals to both Durham VA and local community mental health resources and offered a consult for Durham VA mental health services.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Treatment for Self-Injurious Behaviors</intervention_name>
      <description>Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychosocial functioning.</description>
      <arm_group_label>T-SIB</arm_group_label>
      <other_name>T-SIB</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Treatment As Usual</intervention_name>
      <description>Participants randomized to the TAU condition will be provided with referrals to both Durham VA and local community mental health resources and offered a consult for Durham VA mental health services.</description>
      <arm_group_label>Treatment As Usual</arm_group_label>
      <other_name>TAU</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  Past service in the United States military&#xD;
  &#xD;
            -  Nonsuicidal self-injury engagement on 2 occasions in past 30 days&#xD;
  &#xD;
            -  Fluent in English&#xD;
  &#xD;
            -  Able to provide voluntary informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lifetime history of psychosis, mania, or hypomania&#xD;
  &#xD;
            -  Imminent risk for suicide/homicide warranting immediate intervention&#xD;
  &#xD;
            -  Unable/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>Tate F Halverson, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Durham VA Medical Center, Durham, NC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tate F Halverson, PhD</last_name>
      <phone>(919) 286-0411</phone>
      <phone_ext>175415</phone_ext>
      <email>Tate.Halverson@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Angela C Kirby, MS</last_name>
      <phone>(919) 286-0411</phone>
      <phone_ext>7456</phone_ext>
      <email>angela.kirby@va.gov</email>
    </overall_contact_backup>
    <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>Tate F Halverson, PhD</last_name>
        <phone>919-286-0411</phone>
        <phone_ext>175415</phone_ext>
        <email>Tate.Halverson@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Angela C Kirby, MS</last_name>
        <phone>(919) 286-0411</phone>
        <phone_ext>7456</phone_ext>
        <email>angela.kirby@va.gov</email>
      </contact_backup>
      <investigator>
        <last_name>Tate F Halverson, 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 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Self-Injurious Behavior</keyword>
    <keyword>Veterans</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Self-Injurious Behavior</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05969080
  org study id: D4803-W
  secondary id: 1745432
  nct id: NCT05969080
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue
        without suicidal intent and for purposes that are not socially sanctioned. While NSSI has
        been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is
        approximately three times higher than the general population. Moreover, NSSI is associated
        with increased risk for violence, psychiatric distress, and marked impairment in psychosocial
        functioning. Even though NSSI is distinct from suicidal behaviors in several important ways,
        NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project
        is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to
        reduce psychosocial impairment and NSSI behaviors in Veterans.
  Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue
        without suicidal intent and for purposes that are not socially sanctioned. While NSSI has
        been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is
        approximately three times higher than the general population. Moreover, NSSI is associated
        with increased risk for violence, psychiatric distress, and marked impairment in psychosocial
        functioning. Even though NSSI is distinct from suicidal behaviors in several important ways,
        NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project
        is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to
        reduce psychosocial impairment and NSSI behaviors in Veterans. This treatment, known as the
        Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to
        replace NSSI with behaviors that improve psychoso ial functioning. A core component of T-SIB
        is functional assessment that identifies the antecedents and consequences of NSSI. This
        project will enhance T-SIB by using ecological momentary assessment (EMA) to conduct NSSI
        functional assessment in-vivo. EMA reduces retrospective recall bias and can increase
        engagement with therapeutic goals.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Feasibility as measured by number of participants enrolled
  time frame: 2 years after study enrollment begins
  description: All participants (N = 40) will need to be enrolled by the end of the second year of the study to consider the recruitment benchmark met.
  measure: Feasibility as measured rate of retention
  time frame: End of treatment, about nine weeks after beginning the study
  description: Retention will be measured by the number of participants who complete at least six T-SIB treatment sessions. This benchmark will be considered meet if at least 2/3 of the 20 participants randomized to T-SIB complete at least 6 treatment sessions.
  measure: Number of participants who report satisfaction with the T-SIB treatment
  time frame: End of treatment, about nine weeks after beginning the study
  description: Participant satisfaction will be measured with the Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, which higher scores indicating higher satisfaction. A cut score of 24 will be used such that if the CSQ-8 score exceeds 24, that patient is deemed to have been satisfied with the treatment.
  arm group label: T-SIB
  arm group type: Experimental
  description: Participants randomized to the Treatment for Self-Injurious Behaviors (T-SIB) condition will receive nine sessions of T-SIB.
  arm group label: Treatment As Usual
  arm group type: Active Comparator
  description: Participants randomized to the TAU condition will be provided with referrals to both Durham VA and local community mental health resources and offered a consult for Durham VA mental health services.
  intervention type: Behavioral
  intervention name: Treatment for Self-Injurious Behaviors
  description: Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychosocial functioning.
  arm group label: T-SIB
  other name: T-SIB
  intervention type: Other
  intervention name: Treatment As Usual
  description: Participants randomized to the TAU condition will be provided with referrals to both Durham VA and local community mental health resources and offered a consult for Durham VA mental health services.
  arm group label: Treatment As Usual
  other name: TAU
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tate F Halverson, PhD
  role: Principal Investigator
  affiliation: Durham VA Medical Center, Durham, NC
  last name: Tate F Halverson, PhD
  phone: (919) 286-0411
  phone ext: 175415
  email: Tate.Halverson@va.gov
  last name: Angela C Kirby, MS
  phone: (919) 286-0411
  phone ext: 7456
  email: angela.kirby@va.gov
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Self-Injurious Behavior
  sharing ipd: No