<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/NCT02986113</url>
  </required_header>
  <id_info>
    <org_study_id>922468</org_study_id>
    <secondary_id>U01CE002664</secondary_id>
    <nct_id>NCT02986113</nct_id>
  </id_info>
  <brief_title>Men and Providers Preventing Suicide (MAPS)</brief_title>
  <official_title>Men and Providers Preventing Suicide (MAPS): A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will determine if suicidal middle-aged men who use a personalized computer program&#xD;
      addressing suicide risk before a primary care visit are more likely to discuss suicide and&#xD;
      accept treatment, reducing their suicide preparatory behaviors and thoughts.This is important&#xD;
      because half of all men who die by suicide visit primary care within a month of death, yet&#xD;
      few broach the topic, missing chances for prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators will enroll middle-aged men with active suicide thoughts in&#xD;
      a randomized controlled trial (RCT) to examine whether their use of the Men and Providers&#xD;
      Preventing Suicide (MAPS) tailored interactive multimedia patient activation program&#xD;
      immediately before a primary care provider (PCP) visit, linked with integrated telephone&#xD;
      evidence-based follow-up care (TEBFC) (vs. attention control exposure linked with TEBFC),&#xD;
      reduces suicide preparatory behaviors and ideation over 3 months. About half of all&#xD;
      middle-aged men who die by suicide are seen by a PCP within a month of dying, suggesting the&#xD;
      value of primary care-based suicide prevention efforts, to complement strategies in other&#xD;
      settings. Current impediments to primary care-based prevention are that many suicidal&#xD;
      middle-aged men do not visit a PCP, and among those who do the topic of suicide is rarely&#xD;
      broached, due to societal gender-linked norms (e.g., toughness); stigma; spurious concerns&#xD;
      that talking about suicide increases risk; competing time demands; and lack of resources to&#xD;
      cope with positive responses. PCP-targeted educational interventions have increased detection&#xD;
      of suicidal men, but have inconsistently affected suicide behaviors, and still many suicidal&#xD;
      men went undetected. Suicide behaviors are more likely to be reduced by evidence-based&#xD;
      follow-up care - supportive follow-up contact and collaborative mental health care. However,&#xD;
      such care can only be effective if at-risk men visit a PCP who identifies suicide risk and&#xD;
      offers the care, and the men accept it. Thus, there is a pressing need to study the use of&#xD;
      innovative tools like MAPS to activate at risk middle-aged men to signal their receptiveness&#xD;
      to suicide discussion and care, prompting PCP inquiry and referrals to a form of follow-up&#xD;
      care that is feasible for most practices to implement (e.g., TEBFC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">July 2019</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>Patient: Beck Scale for Suicide Ideation</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient: Reported discussion of suicide during study visits</measure>
    <time_frame>Immediately post-study visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient: suicidal intent scale</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient: enrollment in telephone evidence-based follow-up care</measure>
    <time_frame>Immediately post-study visit, 1 month, 2 months, 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient adherence to telephone evidence-based follow-up care, ascertained from care manager patient contact logs</measure>
    <time_frame>1 month, 2 months, 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient: Interpersonal Needs Questionnaire</measure>
    <time_frame>1 month, 2 months, 3 months</time_frame>
    <description>Perceived burdensomeness and belongingness to others</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient: augmented Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>1 month, 2 months, 3 months</time_frame>
    <description>PHQ-9 plus six &quot;male depression&quot; items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient: Short Form-12 health survey (SF-12) Mental Component Summary score</measure>
    <time_frame>1 month, 2 months, 3 months</time_frame>
    <description>Mental health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient: SF-12 Physical Component Summary score</measure>
    <time_frame>1 month, 2 months, 3 months</time_frame>
    <description>Physical health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient: Toughness scale</measure>
    <time_frame>1 month, 2 months, 3 months</time_frame>
    <description>Gender-linked views regarding health-related help-seeking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient: perceptions of the study interventions and trial participation questionnaire</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCP: perceptions of baseline training videos questionnaire</measure>
    <time_frame>Immediately after completing the video training</time_frame>
    <description>Measured by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCP: reported discussion of suicide during study visits</measure>
    <time_frame>Immediately post-study visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCP: The number of times that PCPs refer study patients to TEBFC, ascertained from study care manager logs</measure>
    <time_frame>Through study completion, up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCP: attitudes toward caring for suicidal patients questionnaire</measure>
    <time_frame>At study completion, up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCP: perceptions of study participation questionnaire</measure>
    <time_frame>At study completion, up to 3 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient: suicide attempts from electronic medical record and insurance claims database review</measure>
    <time_frame>Up to 3 years follow-up</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The number of times that the trial standardized and proactive safety protocols for patients found to be at heightened acute risk of suicide are invoked, ascertained from patient contact tracking sheets</measure>
    <time_frame>Through study completion, up to 3 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Suicidal Intention</condition>
  <condition>Suicidal Ideation</condition>
  <condition>Suicide, Attempted</condition>
  <arm_group>
    <arm_group_label>Men and Providers Preventing Suicide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tailored interactive multimedia intervention, aimed at activating suicidal middle-aged men to disclose and discuss their suicide thoughts with and be receptive to treatment offers from a primary care provider during a linked office visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep hygiene video</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MAPS tailored multimedia patient activation program</intervention_name>
    <arm_group_label>Men and Providers Preventing Suicide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep hygiene video</intervention_name>
    <description>3 minute video on sleep hygiene produced by HealthiNation</description>
    <arm_group_label>Sleep hygiene video</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone evidence-based follow-up care</intervention_name>
    <description>3 months of suicide-focused collaborative mental health care, directed by a supervising psychiatrist and implemented by a care manager working with the patient and their primary care provider</description>
    <arm_group_label>Men and Providers Preventing Suicide</arm_group_label>
    <arm_group_label>Sleep hygiene video</arm_group_label>
    <other_name>TEBFC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Commitment to Living for Primary Care</intervention_name>
    <description>Brief (30 minutes total time) video modules presenting participating patients' primary care providers with a patient-centered framework for suicide risk assessment and intervention</description>
    <arm_group_label>Men and Providers Preventing Suicide</arm_group_label>
    <arm_group_label>Sleep hygiene video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identified male gender&#xD;
&#xD;
          -  Aged 35-74&#xD;
&#xD;
          -  Has a PCP at a primary care office in one of the two participating health systems who&#xD;
             is actively enrolled in the RCT&#xD;
&#xD;
          -  Active suicide thoughts within past 4 weeks&#xD;
&#xD;
          -  Able to read and speak English; and self-reported adequate vision, hearing, and hand&#xD;
             function to engage with an interactive computer program on a touchscreen electronic&#xD;
             tablet device.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reported or apparent highly unstable medical status (e.g. acute decompensated heart&#xD;
             failure requiring immediate care)&#xD;
&#xD;
          -  Reported or apparent highly unstable mental health status (e.g. acute uncontrolled&#xD;
             psychosis)&#xD;
&#xD;
          -  Presence of terminal illness with death anticipated within 3 months&#xD;
&#xD;
          -  Plan to leave the current primary care office (e.g., transfer care) within 3 months&#xD;
&#xD;
          -  Incarcerated&#xD;
&#xD;
          -  Inability to understand and/or provide informed consent, following appropriate&#xD;
             explanation&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Jerant, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Palo Alto Medical Foundation Research Institute</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Health System</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>October 28, 2019</last_update_submitted>
  <last_update_submitted_qc>October 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicidal Ideation</mesh_term>
    <mesh_term>Suicide, Attempted</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/NCT02986113
org study id: 922468
secondary id: U01CE002664
nct id: NCT02986113
lead sponsor: 
collaborator: 
has dmc: Yes
This study will determine if suicidal middle-aged men who use a personalized computer program
      addressing suicide risk before a primary care visit are more likely to discuss suicide and
      accept treatment, reducing their suicide preparatory behaviors and thoughts.This is important
      because half of all men who die by suicide visit primary care within a month of death, yet
      few broach the topic, missing chances for prevention.
In this study, the investigators will enroll middle-aged men with active suicide thoughts in
      a randomized controlled trial (RCT) to examine whether their use of the Men and Providers
      Preventing Suicide (MAPS) tailored interactive multimedia patient activation program
      immediately before a primary care provider (PCP) visit, linked with integrated telephone
      evidence-based follow-up care (TEBFC) (vs. attention control exposure linked with TEBFC),
      reduces suicide preparatory behaviors and ideation over 3 months. About half of all
      middle-aged men who die by suicide are seen by a PCP within a month of dying, suggesting the
      value of primary care-based suicide prevention efforts, to complement strategies in other
      settings. Current impediments to primary care-based prevention are that many suicidal
      middle-aged men do not visit a PCP, and among those who do the topic of suicide is rarely
      broached, due to societal gender-linked norms (e.g., toughness); stigma; spurious concerns
      that talking about suicide increases risk; competing time demands; and lack of resources to
      cope with positive responses. PCP-targeted educational interventions have increased detection
      of suicidal men, but have inconsistently affected suicide behaviors, and still many suicidal
      men went undetected. Suicide behaviors are more likely to be reduced by evidence-based
      follow-up care - supportive follow-up contact and collaborative mental health care. However,
      such care can only be effective if at-risk men visit a PCP who identifies suicide risk and
      offers the care, and the men accept it. Thus, there is a pressing need to study the use of
      innovative tools like MAPS to activate at risk middle-aged men to signal their receptiveness
      to suicide discussion and care, prompting PCP inquiry and referrals to a form of follow-up
      care that is feasible for most practices to implement (e.g., TEBFC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Patient: Beck Scale for Suicide Ideation
time frame: 3 months
measure: Patient: Reported discussion of suicide during study visits
time frame: Immediately post-study visit
measure: Patient: suicidal intent scale
time frame: 3 months
measure: Patient: enrollment in telephone evidence-based follow-up care
time frame: Immediately post-study visit, 1 month, 2 months, 3 months
measure: Patient adherence to telephone evidence-based follow-up care, ascertained from care manager patient contact logs
time frame: 1 month, 2 months, 3 months
measure: Patient: Interpersonal Needs Questionnaire
time frame: 1 month, 2 months, 3 months
description: Perceived burdensomeness and belongingness to others
measure: Patient: augmented Patient Health Questionnaire (PHQ-9)
time frame: 1 month, 2 months, 3 months
description: PHQ-9 plus six "male depression" items
measure: Patient: Short Form-12 health survey (SF-12) Mental Component Summary score
time frame: 1 month, 2 months, 3 months
description: Mental health status
measure: Patient: SF-12 Physical Component Summary score
time frame: 1 month, 2 months, 3 months
description: Physical health status
measure: Patient: Toughness scale
time frame: 1 month, 2 months, 3 months
description: Gender-linked views regarding health-related help-seeking
measure: Patient: perceptions of the study interventions and trial participation questionnaire
time frame: 3 months
measure: PCP: perceptions of baseline training videos questionnaire
time frame: Immediately after completing the video training
description: Measured by questionnaire
measure: PCP: reported discussion of suicide during study visits
time frame: Immediately post-study visit
measure: PCP: The number of times that PCPs refer study patients to TEBFC, ascertained from study care manager logs
time frame: Through study completion, up to 3 years
measure: PCP: attitudes toward caring for suicidal patients questionnaire
time frame: At study completion, up to 3 years
measure: PCP: perceptions of study participation questionnaire
time frame: At study completion, up to 3 years
measure: Patient: suicide attempts from electronic medical record and insurance claims database review
time frame: Up to 3 years follow-up
measure: The number of times that the trial standardized and proactive safety protocols for patients found to be at heightened acute risk of suicide are invoked, ascertained from patient contact tracking sheets
time frame: Through study completion, up to 3 years
arm group label: Men and Providers Preventing Suicide
arm group type: Experimental
description: Tailored interactive multimedia intervention, aimed at activating suicidal middle-aged men to disclose and discuss their suicide thoughts with and be receptive to treatment offers from a primary care provider during a linked office visit
arm group label: Sleep hygiene video
arm group type: Active Comparator
description: A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk.
intervention type: Behavioral
intervention name: MAPS tailored multimedia patient activation program
arm group label: Men and Providers Preventing Suicide
intervention type: Behavioral
intervention name: Sleep hygiene video
description: 3 minute video on sleep hygiene produced by HealthiNation
arm group label: Sleep hygiene video
intervention type: Behavioral
intervention name: Telephone evidence-based follow-up care
description: 3 months of suicide-focused collaborative mental health care, directed by a supervising psychiatrist and implemented by a care manager working with the patient and their primary care provider
arm group label: Men and Providers Preventing Suicide
arm group label: Sleep hygiene video
other name: TEBFC
intervention type: Behavioral
intervention name: Commitment to Living for Primary Care
description: Brief (30 minutes total time) video modules presenting participating patients' primary care providers with a patient-centered framework for suicide risk assessment and intervention
arm group label: Men and Providers Preventing Suicide
arm group label: Sleep hygiene video
criteria: 
gender: Male
minimum age: 35 Years
maximum age: 64 Years
healthy volunteers: No
last name: Anthony Jerant, MD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Suicide
mesh term: Suicidal Ideation
mesh term: Suicide, Attempted
sharing ipd: No