<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/NCT03241225</url>
  </required_header>
  <id_info>
    <org_study_id>1703018101</org_study_id>
    <secondary_id>P50MH113838</secondary_id>
    <nct_id>NCT03241225</nct_id>
  </id_info>
  <brief_title>EM/PROTECT: Improving Depression in Elder Mistreatment Victims</brief_title>
  <official_title>EM/PROTECT: Improving Depression in Elder Mistreatment Victims</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New York City Department for the Aging</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</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 investigators developed EM/PROTECT, a behavioral intervention for depressed EM (elderly&#xD;
      mistreatment) victims, to work in synergy with EM mistreatment resolution services that&#xD;
      provide safety planning, support services, and links to legal services. PROTECT is built on a&#xD;
      model which postulates that chronic stress promotes dysfunction of the cognitive control&#xD;
      (CCN) and reward networks, impairing the victims' ability to flexibly respond to the&#xD;
      environment and limits their reward activities. PROTECT therapists work with victims to&#xD;
      develop action plans to reduce stress, and to increase rewarding experiences. EM/PROTECT has&#xD;
      been designed in an iterative process with community EM providers of the New York City (NYC)&#xD;
      Department for the Aging (DFTA) to use agencies' routine PHQ-9 depression screening and&#xD;
      referral for service. In the current study, the investigators will compare the effectiveness&#xD;
      of EM/PROTECT with EM enriched with staff training in linking EM victims to community mental&#xD;
      health services (EM/MH). The investigators intend to enroll 80 subjects that will participate&#xD;
      in the study for approximately 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One in ten older adults is a victim of mistreatment, and one third of victims have clinically&#xD;
      significant depressive symptoms. Depression increases mortality and decreases motivation to&#xD;
      take self-protective steps. Yet, no elder mistreatment (EM) agencies have embedded&#xD;
      identification and treatment of depressed EM victims in their programs. The investigators&#xD;
      developed EM/PROTECT, a behavioral intervention for depressed EM victims, to work in synergy&#xD;
      with EM agencies that provide safety planning and links to legal services. EM/PROTECT has&#xD;
      been designed in an iterative process with community EM providers of the NYC Department for&#xD;
      the Aging (DFTA), to utilize agencies' routine depression screening and service referrals.&#xD;
      The investigators propose to collect data on the feasibility and acceptability of EM/PROTECT&#xD;
      as one of three developmental projects under the ALACRITY Center NIMH grant (1 P50&#xD;
      MH113838-01,PI: Alexopoulos) (IRB 1704018108). We will compare the effectiveness of&#xD;
      EM/PROTECT with EM enriched with staff training in linking EM victims to community mental&#xD;
      health services (EM/MH). To ensure rigor and reproducibility, EM/PROTECT or EM/MH will be&#xD;
      offered to randomly assigned depressed EM victims. All EM victims will receive standard EM&#xD;
      resolution services from DFTA. EM staff will screen and refer depressed victims to Cornell&#xD;
      staff, who will describe the study and obtain consent. Standardized assessments will be&#xD;
      conducted by trained raters blind to participant assignment.&#xD;
&#xD;
      In addition, the investigators will use both active and passive sensing technology through&#xD;
      smartphone data collection to supplement in-person data collection with an objective measure&#xD;
      of socialization and behavioral activation. Smartphone data will be used to explore whether&#xD;
      adherence to active recordings and time spent carrying the phone is associated with greater&#xD;
      effectiveness of EM/PROTECT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>The investigators will compare the effectiveness and target engagement of EM/PROTECT with EM enriched with training of EM staff in linking EM victims to mental health services (EM/MH) in order to position us for a fully powered R01. To ensure rigor and reproducibility, EM/PROTECT or EM/MH will be offered to randomly assigned depressed EM victims, and standard assessments will be conducted by trained raters blind to participant assignment and our hypotheses.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Standardized assessments will be conducted by trained raters blind to participant assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinically Significant Depressive Symptoms (MADRS).</measure>
    <time_frame>These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.</time_frame>
    <description>In both conditions, the reduction of clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores on this scale range from 0 to 60, with higher scores indicating more severe depression and lower scores indicating milder depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Quality of Life (WHO-QOL)</measure>
    <time_frame>These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.</time_frame>
    <description>IN both conditions, improvement in assessment of quality of life measured by the World Health Organization Quality of Life (WHOQOL) scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures general health (scores range from 2-10). Domain 2 measures physical health (scores range from 7-35). Domain 3 measures psychological health (scores range from 6-30). Domain 4 measures social health (scores range from 3--15). Domain 5 measures environmental health (scores range from 8-40).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Satisfaction With Study Intervention (CSQ)</measure>
    <time_frame>Assessed after EM/PROTECT sessions completed at six, nine, and twelve weeks after study enrollment.</time_frame>
    <description>Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments. Overall scores range from 3-12. Domain 1 measures met needs. Scores range from 1-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 1-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 1-4 and higher scores indicate greater willingness to return.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>EM/PROTECT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EM/MH</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EM/PROTECT</intervention_name>
    <description>EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services</description>
    <arm_group_label>EM/PROTECT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EM/MH</intervention_name>
    <description>EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.</description>
    <arm_group_label>EM/MH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  55 years of age or older&#xD;
&#xD;
          -  Capacity to consent (per EM staff)&#xD;
&#xD;
          -  Significant depression (per EM staff) as indicated by a score of 10 or above on the&#xD;
             Patient Health Questionnaire-9 (PHQ-9), a widely used screening tool routinely&#xD;
             administered in EM agency settings (the PHQ-9 has a sensitivity of 88% and a&#xD;
             specificity of 88% for major depression)&#xD;
&#xD;
          -  Need for EM services&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active suicidal ideation (MADRS item 10&gt;4)&#xD;
&#xD;
          -  Inability to speak English&#xD;
&#xD;
          -  Axis 1 DSM-5 diagnoses other than unipolar depression or generalized anxiety disorder&#xD;
             (by SCID)&#xD;
&#xD;
          -  Mini-Mental Exam score of 23 or less 5&#xD;
&#xD;
          -  Severe or life-threatening medical illness&#xD;
&#xD;
          -  EM emergency and or referral out of EM agency (per EM staff)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Alexopoulos, MD</last_name>
    <role>Study Director</role>
    <affiliation>Weill Cornell Medicine/New York Presbyterian Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jo Anne Sirey, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Elderly Crime Victim Resource Center of the New York City Department for the Aging</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <results_first_submitted>January 3, 2022</results_first_submitted>
  <results_first_submitted_qc>February 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 3, 2022</results_first_posted>
  <last_update_submitted>February 9, 2022</last_update_submitted>
  <last_update_submitted_qc>February 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Elder abuse</keyword>
  <keyword>Depression</keyword>
  <keyword>Mental health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Center will share its data via the NIMH Data Archive (NDA). Our resource sharing plan is formulated in accordance with the NDA Data Sharing Terms and Conditions. Further, the Center will use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions. This project will share feasibility, acceptability, and preliminary effectiveness data of the developmental study of the behavioral intervention EM/PROTECT. Investigators will comply with NIMH's procedures for data deposition into NDCT, and will let NDCT policies dictate the timetable upon which and avenues through which others will be allowed to access those data. Investigators will make the dataset available to other researchers after the main results have been published. Investigators will de-identify the data in the final datasets prior to release for sharing.</ipd_description>
    <ipd_time_frame>Per NIMH guidelines</ipd_time_frame>
    <ipd_access_criteria>To ensure data and participant security, investigators will make the data available to users only under a data-sharing agreement. All users will first provide to the ALACRITY Center and the co-Investigators with a proposal of hypotheses, variables needed to test these hypotheses, and plans for dissemination of findings. All users will indicate in a signed document: (1) a commitment to using the data only for research purposes; (2) a plan for securing the data; (3) an agreement to either destroying or returning the data once analyses are completed; and (4) an agreement to not share data with other users and to direct all such requests to The ALACRITY Center.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 24, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03241225/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 24, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03241225/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>EM/PROTECT</title>
          <description>This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.&#xD;
EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services</description>
        </group>
        <group group_id="P2">
          <title>EM/MH</title>
          <description>This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.&#xD;
EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>EM/PROTECT</title>
          <description>This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.&#xD;
EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services</description>
        </group>
        <group group_id="B2">
          <title>EM/MH</title>
          <description>This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.&#xD;
EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.</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="24"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="40"/>
          </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="72.04" spread="8.48"/>
                    <measurement group_id="B2" value="73.5" spread="7.53"/>
                    <measurement group_id="B3" value="72.77" spread="8.01"/>
                  </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="19"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clinically Significant Depressive Symptoms (MADRS)</title>
          <description>Montgomery Asberg Depression Rating Scale. Scores on this scale range from 0 to 60, with higher scores indicating more severe depression and lower scores indicating milder depression.</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="24.21" spread="3.09"/>
                    <measurement group_id="B2" value="22.94" spread="5.35"/>
                    <measurement group_id="B3" value="23.58" spread="4.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Assessment of Quality of Life (WHO-QOL)</title>
          <description>World Health Organization-Quality Of Life scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures general health (scores range from 2-10). Domain 2 measures physical health (scores range from 7-35). Domain 3 measures psychological health (scores range from 6-30). Domain 4 measures social health (scores range from 3--15). Domain 5 measures environmental health (scores range from 8-40).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Domain 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.71" spread="2.27"/>
                    <measurement group_id="B2" value="5.44" spread="2.03"/>
                    <measurement group_id="B3" value="5.58" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.33" spread="5.16"/>
                    <measurement group_id="B2" value="20.13" spread="3.36"/>
                    <measurement group_id="B3" value="19.73" spread="4.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.22" spread="5.18"/>
                    <measurement group_id="B2" value="18.06" spread="4.04"/>
                    <measurement group_id="B3" value="18.14" spread="4.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.71" spread="3.01"/>
                    <measurement group_id="B2" value="8.44" spread="2.00"/>
                    <measurement group_id="B3" value="7.58" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.58" spread="7.71"/>
                    <measurement group_id="B2" value="23.88" spread="5.57"/>
                    <measurement group_id="B3" value="23.73" spread="6.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Satisfaction With Study Intervention (CSQ)</title>
          <description>Client Satisfaction Questionnaire. Overall scores range from 3-12. Domain 1 measures met needs. Scores range from 1-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 1-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 1-4 and higher scores indicate greater willingness to return.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Domain 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.95" spread="1.23"/>
                    <measurement group_id="B2" value="2.7" spread="1.49"/>
                    <measurement group_id="B3" value="2.83" spread="1.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.95" spread="1.23"/>
                    <measurement group_id="B2" value="3.00" spread="1.41"/>
                    <measurement group_id="B3" value="2.98" spread="2.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.30" spread="1.22"/>
                    <measurement group_id="B2" value="3.20" spread="1.32"/>
                    <measurement group_id="B3" value="3.25" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinically Significant Depressive Symptoms (MADRS).</title>
        <description>In both conditions, the reduction of clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores on this scale range from 0 to 60, with higher scores indicating more severe depression and lower scores indicating milder depression.</description>
        <time_frame>These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EM/PROTECT</title>
            <description>This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.&#xD;
EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services</description>
          </group>
          <group group_id="O2">
            <title>EM/MH</title>
            <description>This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.&#xD;
EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinically Significant Depressive Symptoms (MADRS).</title>
          <description>In both conditions, the reduction of clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores on this scale range from 0 to 60, with higher scores indicating more severe depression and lower scores indicating milder depression.</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="24"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Outcomes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.21" spread="5.35"/>
                    <measurement group_id="O2" value="22.94" spread="3.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 Outcomes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.59" spread="7.02"/>
                    <measurement group_id="O2" value="17.54" spread="7.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 Outcomes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.80" spread="5.76"/>
                    <measurement group_id="O2" value="22.82" spread="7.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 Outcomes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.64" spread="7.87"/>
                    <measurement group_id="O2" value="13.05" spread="7.39"/>
                  </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>Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.16</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.43</ci_lower_limit>
            <ci_upper_limit>8.61</ci_upper_limit>
            <estimate_desc>Mean change in EM/PROTECT group not significantly different from mean change in EM/MH group, at week 12.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Quality of Life (WHO-QOL)</title>
        <description>IN both conditions, improvement in assessment of quality of life measured by the World Health Organization Quality of Life (WHOQOL) scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures general health (scores range from 2-10). Domain 2 measures physical health (scores range from 7-35). Domain 3 measures psychological health (scores range from 6-30). Domain 4 measures social health (scores range from 3--15). Domain 5 measures environmental health (scores range from 8-40).</description>
        <time_frame>These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EM/PROTECT</title>
            <description>This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.&#xD;
EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services</description>
          </group>
          <group group_id="O2">
            <title>EM/MH</title>
            <description>This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.&#xD;
EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Quality of Life (WHO-QOL)</title>
          <description>IN both conditions, improvement in assessment of quality of life measured by the World Health Organization Quality of Life (WHOQOL) scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures general health (scores range from 2-10). Domain 2 measures physical health (scores range from 7-35). Domain 3 measures psychological health (scores range from 6-30). Domain 4 measures social health (scores range from 3--15). Domain 5 measures environmental health (scores range from 8-40).</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="24"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Domain 1- Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.71" spread="2.27"/>
                    <measurement group_id="O2" value="5.44" spread="2.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 2- Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.33" spread="5.16"/>
                    <measurement group_id="O2" value="20.13" spread="3.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 3- Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.22" spread="5.18"/>
                    <measurement group_id="O2" value="18.06" spread="4.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 4- Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.71" spread="3.01"/>
                    <measurement group_id="O2" value="8.44" spread="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 5- Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.58" spread="7.71"/>
                    <measurement group_id="O2" value="23.88" spread="5.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 1- Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.70" spread="1.81"/>
                    <measurement group_id="O2" value="4.83" spread="3.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 2- Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.30" spread="3.33"/>
                    <measurement group_id="O2" value="16.17" spread="7.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 3- Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.30" spread="4.23"/>
                    <measurement group_id="O2" value="16.90" spread="3.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 4- Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.20" spread="2.09"/>
                    <measurement group_id="O2" value="6.42" spread="3.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 5- Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.85" spread="5.76"/>
                    <measurement group_id="O2" value="19.92" spread="10.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 1- Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.93" spread="2.64"/>
                    <measurement group_id="O2" value="6.82" spread="1.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 2- Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.14" spread="7.15"/>
                    <measurement group_id="O2" value="22.59" spread="2.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 3- Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.62" spread="4.23"/>
                    <measurement group_id="O2" value="19.53" spread="4.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 4- Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.64" spread="3.37"/>
                    <measurement group_id="O2" value="7.94" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 5- Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.79" spread="8.32"/>
                    <measurement group_id="O2" value="27.00" spread="5.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 1- Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.41" spread="2.00"/>
                    <measurement group_id="O2" value="6.57" spread="1.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 2- Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.88" spread="3.16"/>
                    <measurement group_id="O2" value="20.50" spread="3.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 3-Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.47" spread="4.29"/>
                    <measurement group_id="O2" value="25.00" spread="19.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 4- Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.76" spread="1.99"/>
                    <measurement group_id="O2" value="13.00" spread="8.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 5- Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.59" spread="3.02"/>
                    <measurement group_id="O2" value="27.21" spread="5.01"/>
                  </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>Domain #1, Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.79</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.37</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Domain #2, Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.19</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.70</ci_lower_limit>
            <ci_upper_limit>3.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Domain #3, Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.37</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.99</ci_lower_limit>
            <ci_upper_limit>5.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Domain #4, Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.026</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.75</ci_lower_limit>
            <ci_upper_limit>-0.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Domain #5, Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.66</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.51</ci_lower_limit>
            <ci_upper_limit>2.27</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Satisfaction With Study Intervention (CSQ)</title>
        <description>Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments. Overall scores range from 3-12. Domain 1 measures met needs. Scores range from 1-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 1-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 1-4 and higher scores indicate greater willingness to return.</description>
        <time_frame>Assessed after EM/PROTECT sessions completed at six, nine, and twelve weeks after study enrollment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EM/PROTECT</title>
            <description>This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.&#xD;
EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services</description>
          </group>
          <group group_id="O2">
            <title>EM/MH</title>
            <description>This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.&#xD;
EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Study Intervention (CSQ)</title>
          <description>Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments. Overall scores range from 3-12. Domain 1 measures met needs. Scores range from 1-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 1-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 1-4 and higher scores indicate greater willingness to return.</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="24"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Domain 1- Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.95" spread="1.2"/>
                    <measurement group_id="O2" value="2.70" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 2- Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.95" spread="1.23"/>
                    <measurement group_id="O2" value="3.00" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 3- Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.30" spread="1.22"/>
                    <measurement group_id="O2" value="3.20" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 1- Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" spread="1.06"/>
                    <measurement group_id="O2" value="2.31" spread="1.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 2- Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" spread="1.05"/>
                    <measurement group_id="O2" value="2.69" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 3- Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.41" spread="1.00"/>
                    <measurement group_id="O2" value="2.54" spread="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 1- Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.12" spread="0.93"/>
                    <measurement group_id="O2" value="2.42" spread="1.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 2- Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.53" spread="0.62"/>
                    <measurement group_id="O2" value="2.75" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Domain 3- Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.65" spread="0.61"/>
                    <measurement group_id="O2" value="3.00" spread="1.81"/>
                  </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>
            <groups_desc>Domain #1, Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.14</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.26</ci_lower_limit>
            <ci_upper_limit>1.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Domain #2, Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.047</p_value>
            <p_value_desc>Domain #2</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.011</ci_lower_limit>
            <ci_upper_limit>1.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Domain #3, Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.18</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.34</ci_lower_limit>
            <ci_upper_limit>1.64</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>EM/PROTECT</title>
          <description>This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.&#xD;
EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services</description>
        </group>
        <group group_id="E2">
          <title>EM/MH</title>
          <description>This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.&#xD;
EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Heart attack</sub_title>
                <description>Participant suffered a heart attack</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Stomach surgery</sub_title>
                <description>Participant had a planned surgery to remove a stomach mass</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <description>Participant visited the emergency room due to dehydration.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <description>Participant lost consciousness during a planned doctor's visit</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <description>Participant diagnosed with pneumonia</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <description>Participant fell in their home</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Jo Anne Sirey</name_or_title>
      <organization>Weill Cornell Medicine</organization>
      <phone>914-997-4333</phone>
      <email>jsirey@med.cornell.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/NCT03241225
org study id: 1703018101
secondary id: P50MH113838
nct id: NCT03241225
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The investigators developed EM/PROTECT, a behavioral intervention for depressed EM (elderly
      mistreatment) victims, to work in synergy with EM mistreatment resolution services that
      provide safety planning, support services, and links to legal services. PROTECT is built on a
      model which postulates that chronic stress promotes dysfunction of the cognitive control
      (CCN) and reward networks, impairing the victims' ability to flexibly respond to the
      environment and limits their reward activities. PROTECT therapists work with victims to
      develop action plans to reduce stress, and to increase rewarding experiences. EM/PROTECT has
      been designed in an iterative process with community EM providers of the New York City (NYC)
      Department for the Aging (DFTA) to use agencies' routine PHQ-9 depression screening and
      referral for service. In the current study, the investigators will compare the effectiveness
      of EM/PROTECT with EM enriched with staff training in linking EM victims to community mental
      health services (EM/MH). The investigators intend to enroll 80 subjects that will participate
      in the study for approximately 12 weeks.
One in ten older adults is a victim of mistreatment, and one third of victims have clinically
      significant depressive symptoms. Depression increases mortality and decreases motivation to
      take self-protective steps. Yet, no elder mistreatment (EM) agencies have embedded
      identification and treatment of depressed EM victims in their programs. The investigators
      developed EM/PROTECT, a behavioral intervention for depressed EM victims, to work in synergy
      with EM agencies that provide safety planning and links to legal services. EM/PROTECT has
      been designed in an iterative process with community EM providers of the NYC Department for
      the Aging (DFTA), to utilize agencies' routine depression screening and service referrals.
      The investigators propose to collect data on the feasibility and acceptability of EM/PROTECT
      as one of three developmental projects under the ALACRITY Center NIMH grant (1 P50
      MH113838-01,PI: Alexopoulos) (IRB 1704018108). We will compare the effectiveness of
      EM/PROTECT with EM enriched with staff training in linking EM victims to community mental
      health services (EM/MH). To ensure rigor and reproducibility, EM/PROTECT or EM/MH will be
      offered to randomly assigned depressed EM victims. All EM victims will receive standard EM
      resolution services from DFTA. EM staff will screen and refer depressed victims to Cornell
      staff, who will describe the study and obtain consent. Standardized assessments will be
      conducted by trained raters blind to participant assignment.

      In addition, the investigators will use both active and passive sensing technology through
      smartphone data collection to supplement in-person data collection with an objective measure
      of socialization and behavioral activation. Smartphone data will be used to explore whether
      adherence to active recordings and time spent carrying the phone is associated with greater
      effectiveness of EM/PROTECT.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators will compare the effectiveness and target engagement of EM/PROTECT with EM enriched with training of EM staff in linking EM victims to mental health services (EM/MH) in order to position us for a fully powered R01. To ensure rigor and reproducibility, EM/PROTECT or EM/MH will be offered to randomly assigned depressed EM victims, and standard assessments will be conducted by trained raters blind to participant assignment and our hypotheses.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Standardized assessments will be conducted by trained raters blind to participant assignment.
measure: Clinically Significant Depressive Symptoms (MADRS).
time frame: These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.
description: In both conditions, the reduction of clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores on this scale range from 0 to 60, with higher scores indicating more severe depression and lower scores indicating milder depression.
measure: Assessment of Quality of Life (WHO-QOL)
time frame: These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.
description: IN both conditions, improvement in assessment of quality of life measured by the World Health Organization Quality of Life (WHOQOL) scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures general health (scores range from 2-10). Domain 2 measures physical health (scores range from 7-35). Domain 3 measures psychological health (scores range from 6-30). Domain 4 measures social health (scores range from 3--15). Domain 5 measures environmental health (scores range from 8-40).
measure: Satisfaction With Study Intervention (CSQ)
time frame: Assessed after EM/PROTECT sessions completed at six, nine, and twelve weeks after study enrollment.
description: Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments. Overall scores range from 3-12. Domain 1 measures met needs. Scores range from 1-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 1-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 1-4 and higher scores indicate greater willingness to return.
arm group label: EM/PROTECT
arm group type: Experimental
description: This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.
arm group label: EM/MH
arm group type: Active Comparator
description: This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.
intervention type: Behavioral
intervention name: EM/PROTECT
description: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services
arm group label: EM/PROTECT
intervention type: Behavioral
intervention name: EM/MH
description: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.
arm group label: EM/MH
criteria: 
gender: All
minimum age: 55 Years
maximum age: 100 Years
healthy volunteers: No
last name: George Alexopoulos, MD
role: Study Director
affiliation: Weill Cornell Medicine/New York Presbyterian Hospital
last name: Jo Anne Sirey, PhD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Yes
ipd description: The Center will share its data via the NIMH Data Archive (NDA). Our resource sharing plan is formulated in accordance with the NDA Data Sharing Terms and Conditions. Further, the Center will use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions. This project will share feasibility, acceptability, and preliminary effectiveness data of the developmental study of the behavioral intervention EM/PROTECT. Investigators will comply with NIMH's procedures for data deposition into NDCT, and will let NDCT policies dictate the timetable upon which and avenues through which others will be allowed to access those data. Investigators will make the dataset available to other researchers after the main results have been published. Investigators will de-identify the data in the final datasets prior to release for sharing.
ipd time frame: Per NIMH guidelines
ipd access criteria: To ensure data and participant security, investigators will make the data available to users only under a data-sharing agreement. All users will first provide to the ALACRITY Center and the co-Investigators with a proposal of hypotheses, variables needed to test these hypotheses, and plans for dissemination of findings. All users will indicate in a signed document: (1) a commitment to using the data only for research purposes; (2) a plan for securing the data; (3) an agreement to either destroying or returning the data once analyses are completed; and (4) an agreement to not share data with other users and to direct all such requests to The ALACRITY Center.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 