<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/NCT04488055</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00164699</org_study_id>
    <secondary_id>1R01AA027513-01</secondary_id>
    <nct_id>NCT04488055</nct_id>
  </id_info>
  <brief_title>Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients (Reach Out)</brief_title>
  <official_title>Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to learn about people who use the National Suicide&#xD;
      Prevention (NSP) Lifeline during a suicidal crisis and those who don't. The researchers would&#xD;
      also like to learn whether people who have experienced a suicidal crisis could benefit from&#xD;
      participating in a therapy session about their thoughts and perceptions of the NSP Lifeline.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 15, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Crisis line utilization</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The Time Line Follow Back (TLFB) assessment will be used as the primary measure of crisis line utilization. Participants will report days of utilization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Suicidal behavior</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The Time Line Follow Back (TLFB) assessment will be the primary measure of suicidal behavior. Participants will report days with suicidal behavior.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Suicide</condition>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Crisis Line Facilitation (CLF)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This single-session intervention addresses the individuals' perceived barriers and facilitators of crisis line use during periods of suicidal crisis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Usual Care (EUC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to the EUC condition will receive a brochure (in-person, via email, or via text message) with the NSP Lifeline and a list of outpatient mental health and substance use resources and encouraged to schedule an appointment with a clinical provider if they would like to discuss any current or past symptoms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Crisis Line Facilitation (CLF)</intervention_name>
    <description>CLF is a motivational interviewing-based intervention</description>
    <arm_group_label>Crisis Line Facilitation (CLF)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Usual Care (EUC)</intervention_name>
    <description>In addition to receiving the brochure, EUC condition participants will meet with a therapist (in-person or remotely) for approximately 15 minutes for a descriptive overview of the brochure.</description>
    <arm_group_label>Enhanced Usual Care (EUC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Probable alcohol use disorder within the past year based on an Alcohol Use Disorders&#xD;
             Identification Test (AUDIT) score of 16 or greater&#xD;
&#xD;
          -  Report of a suicide attempt within the past year OR a lifetime suicide attempt more&#xD;
             than a year ago and current suicide ideation within the past month based on a score of&#xD;
             5 or greater on the Beck Scale for Suicidal Ideation (BSS) or depression in the past&#xD;
             month as measured by the Beck Depression Inventory with a of 20 or higher.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not understand English&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Patients with profound psychotic symptoms and/or cognitive deficits that would prevent&#xD;
             patients from understanding the content of the intervention and/or assessments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Ilgen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amanda Price, MS</last_name>
    <phone>734-998-6652</phone>
    <email>amhprice@med.umich.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Detroit Rescue Mission Ministries</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amanda Price, MS</last_name>
      <phone>734-998-6652</phone>
      <email>amhprice@med.umich.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Meridian Health Services</name>
      <address>
        <city>Waterford</city>
        <state>Michigan</state>
        <zip>48327</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amanda Price, MS</last_name>
      <phone>734-998-6652</phone>
      <email>amhprice@med.umich.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Mark A. Ilgen</investigator_full_name>
    <investigator_title>Professor, Department of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>National Suicide Prevention Lifeline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicide Prevention</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/NCT04488055
org study id: HUM00164699
secondary id: 1R01AA027513-01
nct id: NCT04488055
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to learn about people who use the National Suicide
      Prevention (NSP) Lifeline during a suicidal crisis and those who don't. The researchers would
      also like to learn whether people who have experienced a suicidal crisis could benefit from
      participating in a therapy session about their thoughts and perceptions of the NSP Lifeline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Crisis line utilization
time frame: Up to 12 months
description: The Time Line Follow Back (TLFB) assessment will be used as the primary measure of crisis line utilization. Participants will report days of utilization.
measure: Suicidal behavior
time frame: Up to 12 months
description: The Time Line Follow Back (TLFB) assessment will be the primary measure of suicidal behavior. Participants will report days with suicidal behavior.
arm group label: Crisis Line Facilitation (CLF)
arm group type: Experimental
description: This single-session intervention addresses the individuals' perceived barriers and facilitators of crisis line use during periods of suicidal crisis.
arm group label: Enhanced Usual Care (EUC)
arm group type: Active Comparator
description: Participants randomized to the EUC condition will receive a brochure (in-person, via email, or via text message) with the NSP Lifeline and a list of outpatient mental health and substance use resources and encouraged to schedule an appointment with a clinical provider if they would like to discuss any current or past symptoms.
intervention type: Behavioral
intervention name: Crisis Line Facilitation (CLF)
description: CLF is a motivational interviewing-based intervention
arm group label: Crisis Line Facilitation (CLF)
intervention type: Behavioral
intervention name: Enhanced Usual Care (EUC)
description: In addition to receiving the brochure, EUC condition participants will meet with a therapist (in-person or remotely) for approximately 15 minutes for a descriptive overview of the brochure.
arm group label: Enhanced Usual Care (EUC)
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Ilgen, PhD
role: Principal Investigator
affiliation: University of Michigan
last name: Amanda Price, MS
phone: 734-998-6652
email: amhprice@med.umich.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Mark A. Ilgen
investigator title: Professor, Department of Psychiatry
mesh term: Alcoholism
mesh term: Suicide
mesh term: Suicide Prevention
sharing ipd: No