<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/NCT02188485</url>
  </required_header>
  <id_info>
    <org_study_id>K23MH096936</org_study_id>
    <secondary_id>K23MH096936</secondary_id>
    <nct_id>NCT02188485</nct_id>
  </id_info>
  <brief_title>Social Connections and Late Life Suicide</brief_title>
  <official_title>Social Connections and Late Life Suicide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      With the long-term goal of improving interventions for late-life suicide, the purpose of this&#xD;
      study is to examine whether a mechanism by which behavioral interventions reduce risk for&#xD;
      late-life suicide is by increasing social connectedness. The investigators propose to examine&#xD;
      whether a manualized intervention that targets connectedness--ENGAGE--increases connectedness&#xD;
      in older adults who report clinically significant depression and&#xD;
      disconnectedness-operationalized as feeling lonely and/or like a burden on others. The&#xD;
      investigators propose a randomized controlled trial comparing the ENGAGE intervention with&#xD;
      care-as-usual (CAU), using n=100 primary care patients aged ≥ 60 years who report social&#xD;
      disconnectedness (i.e., loneliness or burdensomeness) and either Minor or Major Depression.&#xD;
      At baseline, 3-week, 6-week and 10-week assessments, subjects will report on social&#xD;
      connectedness, depression, and suicide risk. The investigators hypothesize that those&#xD;
      subjects assigned to ENGAGE will report greater increases in connectedness-measured as&#xD;
      greater belongingness and lower burdensomeness-compared to CAU; that ENGAGE will produce&#xD;
      greater reductions in depression and suicide ideation than CAU; and that changes in&#xD;
      depression will be accounted for changes in social connectedness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">May 30, 2017</completion_date>
  <primary_completion_date type="Actual">May 30, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Social Connectedness</measure>
    <time_frame>10 weeks</time_frame>
    <description>Severity of social disconnectedness at 10 weeks, operationalized as thwarted belongingness and perceived burdensomeness, measured by the Interpersonal Needs Questionnaire. Scores on the thwarted belonging subscale range from 0-18, with greater scores indicating greater thwarted belonging (i.e., worse outcome). Scores on the perceived burden subscale range from 0-12, with greater scores indicating greater perceived burden on others (i.e., worse outcome).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Suicide Ideation</measure>
    <time_frame>10 weeks</time_frame>
    <description>Suicide ideation at 10 weeks, measured by the Geriatric Suicide ideation scale, with scores ranging from 4 to 20, with greater scores indicating greater suicide ideation (i.e., worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>10 weeks</time_frame>
    <description>Depression severity was measured with the Quick Inventory of Depressive Symptomatology (QIDS), interviewer rated version, with scores ranging from 0 to 27, with higher scores indicating greater depression (worse outcomes).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Depression</condition>
  <condition>Suicidal Ideation</condition>
  <arm_group>
    <arm_group_label>ENGAGE: a social engagement intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Care-as-Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Care as usual in primary care with study assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ENGAGE</intervention_name>
    <description>Up to 10 sessions delivered in the home.</description>
    <arm_group_label>ENGAGE: a social engagement intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 60 yrs;&#xD;
&#xD;
          -  English speaking;&#xD;
&#xD;
          -  Reside in the community;&#xD;
&#xD;
          -  Endorse social disconnectedness, as measured by feeling lonely and/or like a burden on&#xD;
             others;&#xD;
&#xD;
          -  Meet criteria for Minor or Major Depression.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Imminent risk for suicide;&#xD;
&#xD;
          -  Active psychosis;&#xD;
&#xD;
          -  Significantly impaired cognitive functioning (i.e., MOCA &lt;23);&#xD;
&#xD;
          -  Active substance abuse in the last year (AUDIT score of 5 or more);&#xD;
&#xD;
          -  Hearing loss that precludes comfortable communication;&#xD;
&#xD;
          -  Residence in a long-term care facility.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimberly A Van Orden, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Van Orden, K. A., et al.</citation>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <results_first_submitted>April 9, 2021</results_first_submitted>
  <results_first_submitted_qc>September 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 7, 2021</results_first_posted>
  <last_update_submitted>September 10, 2021</last_update_submitted>
  <last_update_submitted_qc>September 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Kimberly Van Orden</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </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>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 19, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT02188485/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from primary care and an outpatient geriatric psychiatry clinic.</recruitment_details>
      <pre_assignment_details>Eligibility criteria were assessed at a baseline interview prior to randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>ENGAGE: a Social Engagement Intervention</title>
          <description>ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness).&#xD;
ENGAGE: Up to 10 sessions delivered in the home.</description>
        </group>
        <group group_id="P2">
          <title>Care-as-Usual</title>
          <description>Care as usual in primary care with study assessments.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>PI withdrew, lack of capacity</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ENGAGE: a Social Engagement Intervention</title>
          <description>ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness).&#xD;
ENGAGE: Up to 10 sessions delivered in the home.</description>
        </group>
        <group group_id="B2">
          <title>Care-as-Usual</title>
          <description>Care as usual in primary care with study assessments.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="62"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.78" spread="9.27"/>
                    <measurement group_id="B2" value="71.46" spread="8.96"/>
                    <measurement group_id="B3" value="72" spread="9.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Depression Symptom Severity</title>
          <description>Depression severity was measured with the 16-item Quick Inventory of Depressive Symptomatology (QIDS), interviewer rated version, with scores ranging from 0 to 27, with higher scores indicating greater depression (worse outcomes).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.41" spread="4.32"/>
                    <measurement group_id="B2" value="7.37" spread="5.26"/>
                    <measurement group_id="B3" value="7.90" spread="4.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Low Belonging (INQ-TB)</title>
          <description>Thwarted (low) belonging was measured by the Interpersonal Needs Questionnaire, thwarted belonging subscale (INQ-TB). Scores on the thwarted belonging subscale range from 0-18, with greater scores indicating greater thwarted belonging (i.e., worse outcome).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.47" spread="3.69"/>
                    <measurement group_id="B2" value="5.97" spread="4.11"/>
                    <measurement group_id="B3" value="6.23" spread="3.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Perceived burden (INQ-PB)</title>
          <description>Perceived burdensomeness was measured by the Interpersonal Needs Questionnaire Perceived Burden subscale (INQ-PB). Scores on the perceived burden subscale range from 0-12, with greater scores indicating greater perceived burden on others (i.e., worse outcome).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.25" spread="1.98"/>
                    <measurement group_id="B2" value="1.23" spread="1.98"/>
                    <measurement group_id="B3" value="1.25" spread="1.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Suicide Ideation (GSIS)</title>
          <description>Suicide ideation was measured by the Geriatric Suicide ideation scale, with scores ranging from 4 to 20, with greater scores indicating greater suicide ideation (i.e., worse outcome).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.81" spread="3.27"/>
                    <measurement group_id="B2" value="7.77" spread="3.14"/>
                    <measurement group_id="B3" value="7.79" spread="3.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Social Connectedness</title>
        <description>Severity of social disconnectedness at 10 weeks, operationalized as thwarted belongingness and perceived burdensomeness, measured by the Interpersonal Needs Questionnaire. Scores on the thwarted belonging subscale range from 0-18, with greater scores indicating greater thwarted belonging (i.e., worse outcome). Scores on the perceived burden subscale range from 0-12, with greater scores indicating greater perceived burden on others (i.e., worse outcome).</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ENGAGE: a Social Engagement Intervention</title>
            <description>ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness).&#xD;
ENGAGE: Up to 10 sessions delivered in the home.</description>
          </group>
          <group group_id="O2">
            <title>Care-as-Usual</title>
            <description>Care as usual in primary care with study assessments.</description>
          </group>
        </group_list>
        <measure>
          <title>Social Connectedness</title>
          <description>Severity of social disconnectedness at 10 weeks, operationalized as thwarted belongingness and perceived burdensomeness, measured by the Interpersonal Needs Questionnaire. Scores on the thwarted belonging subscale range from 0-18, with greater scores indicating greater thwarted belonging (i.e., worse outcome). Scores on the perceived burden subscale range from 0-12, with greater scores indicating greater perceived burden on others (i.e., worse outcome).</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Thwarted Belonging (INQ)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" spread="3.49"/>
                    <measurement group_id="O2" value="4.30" spread="4.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Perceived burden (INQ</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.77" spread="1.92"/>
                    <measurement group_id="O2" value="0.82" spread="1.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Thwarted belonging (INQ-TB) at 10 week follow-up</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.278</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-.79</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.72</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Perceived burden (INQ-PB) at 10-week follow-up</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.591</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.38</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Suicide Ideation</title>
        <description>Suicide ideation at 10 weeks, measured by the Geriatric Suicide ideation scale, with scores ranging from 4 to 20, with greater scores indicating greater suicide ideation (i.e., worse outcome).</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ENGAGE: a Social Engagement Intervention</title>
            <description>ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness).&#xD;
ENGAGE: Up to 10 sessions delivered in the home.</description>
          </group>
          <group group_id="O2">
            <title>Care-as-Usual</title>
            <description>Care as usual in primary care with study assessments.</description>
          </group>
        </group_list>
        <measure>
          <title>Suicide Ideation</title>
          <description>Suicide ideation at 10 weeks, measured by the Geriatric Suicide ideation scale, with scores ranging from 4 to 20, with greater scores indicating greater suicide ideation (i.e., worse outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="2.93"/>
                    <measurement group_id="O2" value="6.56" spread="3.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.511</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.52</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression</title>
        <description>Depression severity was measured with the Quick Inventory of Depressive Symptomatology (QIDS), interviewer rated version, with scores ranging from 0 to 27, with higher scores indicating greater depression (worse outcomes).</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ENGAGE: a Social Engagement Intervention</title>
            <description>ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness).&#xD;
ENGAGE: Up to 10 sessions delivered in the home.</description>
          </group>
          <group group_id="O2">
            <title>Care-as-Usual</title>
            <description>Care as usual in primary care with study assessments.</description>
          </group>
        </group_list>
        <measure>
          <title>Depression</title>
          <description>Depression severity was measured with the Quick Inventory of Depressive Symptomatology (QIDS), interviewer rated version, with scores ranging from 0 to 27, with higher scores indicating greater depression (worse outcomes).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.37" spread="3.63"/>
                    <measurement group_id="O2" value="6.15" spread="4.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.014</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.85</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participant engagement in the study (i.e., 10 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ENGAGE: a Social Engagement Intervention</title>
          <description>ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness).&#xD;
ENGAGE: Up to 10 sessions delivered in the home.</description>
        </group>
        <group group_id="E2">
          <title>Care-as-Usual</title>
          <description>Care as usual in primary care with study assessments.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric hospitalization</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The primary limitation was the sample size that was underpowered to detect small changes in target mechanisms and suicide ideation. A lack of assessment of social engagement in both groups limited our ability to fully examine this potential target mechanism. Aspects of the study design that increase generalizability to the population of interest also created a heterogenous sample with regards to functioning and contributors to disconnection that may reduce precision for detecting effects.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kim Van Orden, PhD</name_or_title>
      <organization>University of Rochester</organization>
      <phone>585-275-5176</phone>
      <email>kimberly_vanorden@urmc.rochester.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02188485
org study id: K23MH096936
secondary id: K23MH096936
nct id: NCT02188485
lead sponsor: 
collaborator: 
has dmc: Yes
With the long-term goal of improving interventions for late-life suicide, the purpose of this
      study is to examine whether a mechanism by which behavioral interventions reduce risk for
      late-life suicide is by increasing social connectedness. The investigators propose to examine
      whether a manualized intervention that targets connectedness--ENGAGE--increases connectedness
      in older adults who report clinically significant depression and
      disconnectedness-operationalized as feeling lonely and/or like a burden on others. The
      investigators propose a randomized controlled trial comparing the ENGAGE intervention with
      care-as-usual (CAU), using n=100 primary care patients aged ≥ 60 years who report social
      disconnectedness (i.e., loneliness or burdensomeness) and either Minor or Major Depression.
      At baseline, 3-week, 6-week and 10-week assessments, subjects will report on social
      connectedness, depression, and suicide risk. The investigators hypothesize that those
      subjects assigned to ENGAGE will report greater increases in connectedness-measured as
      greater belongingness and lower burdensomeness-compared to CAU; that ENGAGE will produce
      greater reductions in depression and suicide ideation than CAU; and that changes in
      depression will be accounted for changes in social connectedness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Social Connectedness
time frame: 10 weeks
description: Severity of social disconnectedness at 10 weeks, operationalized as thwarted belongingness and perceived burdensomeness, measured by the Interpersonal Needs Questionnaire. Scores on the thwarted belonging subscale range from 0-18, with greater scores indicating greater thwarted belonging (i.e., worse outcome). Scores on the perceived burden subscale range from 0-12, with greater scores indicating greater perceived burden on others (i.e., worse outcome).
measure: Suicide Ideation
time frame: 10 weeks
description: Suicide ideation at 10 weeks, measured by the Geriatric Suicide ideation scale, with scores ranging from 4 to 20, with greater scores indicating greater suicide ideation (i.e., worse outcome).
measure: Depression
time frame: 10 weeks
description: Depression severity was measured with the Quick Inventory of Depressive Symptomatology (QIDS), interviewer rated version, with scores ranging from 0 to 27, with higher scores indicating greater depression (worse outcomes).
arm group label: ENGAGE: a social engagement intervention
arm group type: Experimental
description: ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness).
arm group label: Care-as-Usual
arm group type: No Intervention
description: Care as usual in primary care with study assessments.
intervention type: Behavioral
intervention name: ENGAGE
description: Up to 10 sessions delivered in the home.
arm group label: ENGAGE: a social engagement intervention
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Kimberly A Van Orden, PhD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
citation: Van Orden, K. A., et al.
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Kimberly Van Orden
investigator title: Assistant Professor
mesh term: Suicide
mesh term: Suicidal Ideation
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The primary limitation was the sample size that was underpowered to detect small changes in target mechanisms and suicide ideation. A lack of assessment of social engagement in both groups limited our ability to fully examine this potential target mechanism. Aspects of the study design that increase generalizability to the population of interest also created a heterogenous sample with regards to functioning and contributors to disconnection that may reduce precision for detecting effects.
point of contact: 