<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/NCT04463225</url>
  </required_header>
  <id_info>
    <org_study_id>IRB0009650</org_study_id>
    <secondary_id>W81XWH1920001;CDMRP-BA160401</secondary_id>
    <nct_id>NCT04463225</nct_id>
  </id_info>
  <brief_title>The Network Study: Soldiers Connecting for Work and Health</brief_title>
  <official_title>Patterns of Alcohol Use and Suicide-related Thoughts Among Recently Discharged Veterans: Risk Factors Associated With the Military-to-Veteran Transition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cornell University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the efficacy of an internet-based brief intervention designed to&#xD;
      reduce risky behavior in Soldiers as they transition from Active Duty into the civilian&#xD;
      workforce as a Veteran. Up to 700 soldiers intending to separate from the Army will be&#xD;
      recruited, with the intention of drawing a final sample of 450 participants. Study&#xD;
      participants will be randomly assigned to either the intervention or the control group,&#xD;
      stratified by age and gender.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The combination of alcohol use and negative emotional states is a particularly toxic&#xD;
      combination for suicide risk. The current study examines changes in alcohol/drug use/misuse&#xD;
      and depression as soldiers undergo the transition from Active Duty to Veteran and offers a&#xD;
      personalized internet-based brief intervention intended to prevent/reduce alcohol misuse and&#xD;
      depression in this population.&#xD;
&#xD;
      The study's objectives are to empirically quantify the form of changes that occur with&#xD;
      respect to alcohol use and depression over the transition; to identify stable individual risk&#xD;
      factors (e.g., personality, military experiences) and dynamic risk factors (e.g., changes in&#xD;
      stressors and normative contexts over time) that may be associated with differential temporal&#xD;
      patterns of suicide-related behavior (i.e., alcohol use/misuse) and cognition (i.e.,&#xD;
      depression); and lastly, to determine whether a simple, internet-delivered brief intervention&#xD;
      shown can reduce risky behavior in the transitioning Veteran population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 30, 2021</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2024</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>One group will receive three opportunities to engage with a personalized internet-delivered brief intervention over the course of seven months and the second group will not be granted access.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Heavy Episodic Drinking</measure>
    <time_frame>Through study completion, an average of monthly over 15 months</time_frame>
    <description>Description Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Modal alcohol consumption</measure>
    <time_frame>Through study completion, an average of monthly over 15 months</time_frame>
    <description>Daily Drinking Questionnaire (DDQ) (Collins, Parks, &amp; Marlatt, 1985)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Negative Emotional State -- Depression</measure>
    <time_frame>Through study completion, an average of monthly over 15 months</time_frame>
    <description>The Patient Health Questionnaire (PHQ)-9</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Alcohol-related problems</measure>
    <time_frame>Through study completion, an average of monthly over 15 months</time_frame>
    <description>Short Rutgers Alcohol Problems Index (S-RAPI) (Earleywine, LaBrie &amp; Pedersen)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Suicidal ideation</measure>
    <time_frame>Through study completion, an average of monthly over 15 months</time_frame>
    <description>Measure developed by Nock et al., 2007</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Employment</measure>
    <time_frame>Through study completion, an average of monthly over 15 months</time_frame>
    <description>Current job situation/Change employment</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Intervention condition</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants assigned to the intervention condition will be invited to engage with an internet-based intervention three times during the course of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will not be offered the internet-based intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet-Delivered Brief Intervention</intervention_name>
    <description>The internet-delivered brief intervention developed for the study can be accessed via computers and mobile devices.. The intervention will employ assessment data to give study participants feedback on their drinking behavior and offer strategies to avoid risky behavior.</description>
    <arm_group_label>Intervention condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is US solider intending to separate from active duty during the study enrollment&#xD;
             period&#xD;
&#xD;
          -  Intends to seek civilian employment&#xD;
&#xD;
          -  Plans to live in US&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Plans to retire and not seek civilian employment&#xD;
&#xD;
          -  Plans to live outside of the US&#xD;
&#xD;
          -  Is separating or retiring from the National Guard or Reserves&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The study will recruit up to 700 soldiers intending to separate from the Army in the initial phase of the study with the intention of securing a final sample of 450. Of the 450, 400 will be selected regardless of gender, but an additional 50 female soldiers will be recruited intentionally.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>62 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel Bacharach, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samuel Bacharach, Ph.D.</last_name>
    <phone>212-340-2850</phone>
    <email>sb22@cornell.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Paul D Bliese, Ph.D.</last_name>
    <email>Paul.Bliese@moore.sc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Joint Base Lewis-McChord</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98433</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherry Matheney</last_name>
      <phone>253-477-4744</phone>
      <email>sherry.k.matheney.civ@army.mil</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>May 24, 2023</last_update_submitted>
  <last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Negative Emotional States</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Alcohol norms</keyword>
  <keyword>Trauma</keyword>
  <keyword>PTSD</keyword>
  <keyword>Stress</keyword>
  <keyword>Self-medication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04463225
org study id: IRB0009650
secondary id: W81XWH1920001;CDMRP-BA160401
nct id: NCT04463225
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine the efficacy of an internet-based brief intervention designed to
      reduce risky behavior in Soldiers as they transition from Active Duty into the civilian
      workforce as a Veteran. Up to 700 soldiers intending to separate from the Army will be
      recruited, with the intention of drawing a final sample of 450 participants. Study
      participants will be randomly assigned to either the intervention or the control group,
      stratified by age and gender.
The combination of alcohol use and negative emotional states is a particularly toxic
      combination for suicide risk. The current study examines changes in alcohol/drug use/misuse
      and depression as soldiers undergo the transition from Active Duty to Veteran and offers a
      personalized internet-based brief intervention intended to prevent/reduce alcohol misuse and
      depression in this population.

      The study's objectives are to empirically quantify the form of changes that occur with
      respect to alcohol use and depression over the transition; to identify stable individual risk
      factors (e.g., personality, military experiences) and dynamic risk factors (e.g., changes in
      stressors and normative contexts over time) that may be associated with differential temporal
      patterns of suicide-related behavior (i.e., alcohol use/misuse) and cognition (i.e.,
      depression); and lastly, to determine whether a simple, internet-delivered brief intervention
      shown can reduce risky behavior in the transitioning Veteran population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One group will receive three opportunities to engage with a personalized internet-delivered brief intervention over the course of seven months and the second group will not be granted access.
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Heavy Episodic Drinking
time frame: Through study completion, an average of monthly over 15 months
description: Description Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)
measure: Change in Modal alcohol consumption
time frame: Through study completion, an average of monthly over 15 months
description: Daily Drinking Questionnaire (DDQ) (Collins, Parks, & Marlatt, 1985)
measure: Change in Negative Emotional State -- Depression
time frame: Through study completion, an average of monthly over 15 months
description: The Patient Health Questionnaire (PHQ)-9
measure: Change in Alcohol-related problems
time frame: Through study completion, an average of monthly over 15 months
description: Short Rutgers Alcohol Problems Index (S-RAPI) (Earleywine, LaBrie & Pedersen)
measure: Change in Suicidal ideation
time frame: Through study completion, an average of monthly over 15 months
description: Measure developed by Nock et al., 2007
measure: Change in Employment
time frame: Through study completion, an average of monthly over 15 months
description: Current job situation/Change employment
arm group label: Intervention condition
arm group type: Other
description: Participants assigned to the intervention condition will be invited to engage with an internet-based intervention three times during the course of the study.
arm group label: Control
arm group type: No Intervention
description: The control group will not be offered the internet-based intervention.
intervention type: Other
intervention name: Internet-Delivered Brief Intervention
description: The internet-delivered brief intervention developed for the study can be accessed via computers and mobile devices.. The intervention will employ assessment data to give study participants feedback on their drinking behavior and offer strategies to avoid risky behavior.
arm group label: Intervention condition
criteria: 
gender: All
gender based: Yes
gender description: The study will recruit up to 700 soldiers intending to separate from the Army in the initial phase of the study with the intention of securing a final sample of 450. Of the 450, 400 will be selected regardless of gender, but an additional 50 female soldiers will be recruited intentionally.
minimum age: 18 Years
maximum age: 62 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Samuel Bacharach, Ph.D.
role: Principal Investigator
affiliation: Cornell University
last name: Samuel Bacharach, Ph.D.
phone: 212-340-2850
email: sb22@cornell.edu
last name: Paul D Bliese, Ph.D.
email: Paul.Bliese@moore.sc.edu
facility: 
status: Recruiting
contact: 
country: United States
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responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Alcohol Drinking
sharing ipd: No