<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/NCT03246789</url>
  </required_header>
  <id_info>
    <org_study_id>1704018114</org_study_id>
    <secondary_id>P50MH113838</secondary_id>
    <nct_id>NCT03246789</nct_id>
  </id_info>
  <brief_title>Reaching and Engaging Depressed Senior Center Clients (REDS)</brief_title>
  <acronym>REDS</acronym>
  <official_title>Reaching and Engaging Depressed Senior Center Clients</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>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the feasibility of two types of group therapy sessions.&#xD;
      The research is being done because the researchers are trying to learn if these approaches&#xD;
      could be used by therapist in the community social service agencies to treat older adults&#xD;
      with depression. There are two study groups. One group is a form of group therapy called&#xD;
      &quot;Engage-M&quot;, which encourages subjects to engage in physical and social activities that they&#xD;
      find pleasurable or rewarding. One group is another form of group therapy called, &quot;Wellness&#xD;
      in Mind and Body&quot;, which focuses on education and de-stigmatization of health and mental&#xD;
      health conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In response to the large numbers of senior center clients who suffer from untreated&#xD;
      depression, we have partnered with the NYC Department for the Aging (DFTA) to develop&#xD;
      SMART-MH, a community care model that can be embedded in senior centers to improve&#xD;
      recognition, referral, and adherence to depression treatment. The investigators also&#xD;
      developed and tested Engage, a stepped-care therapy streamlined to use &quot;reward exposure&quot; as&#xD;
      its principal intervention based on the assumption that dysfunction of the reward networks is&#xD;
      central to the pathogenesis of depression. With senior center partners and a mobile&#xD;
      technology team, the investigators redesigned Engage-M so that it can be used in a group&#xD;
      format by licensed clinical social workers (LCSWs) of Senior Centers. Mobile technology&#xD;
      provides probes for client adherence and offers to therapists easy to review summary records&#xD;
      of mood, activity, and social interaction that can be used to target their sessions. The&#xD;
      investigators have integrated SMART-MH and Engage-M into a comprehensive community care model&#xD;
      &quot;Reaching and Engaging Depressed Senior Center Clients&quot; (REDS).&#xD;
&#xD;
      The specific aims of this developmental project are to: 1. Finalize the REDS protocol and&#xD;
      assess feasibility of training; 2. Prepare an Operations' Manual; 3. Examine reach,&#xD;
      feasibility, and acceptability of REDS; 4. Examine engagement of behavioral targets and&#xD;
      preliminary effectiveness; and 5. Collect information on REDS cost, barriers to&#xD;
      implementation, and potential savings in health care utilization.&#xD;
&#xD;
      The investigators will randomly assign four senior centers to offer either Engage-M (N=40),&#xD;
      the treatment offered by REDS (1 individual and 8 weekly group sessions) or 8 group sessions&#xD;
      &quot;Wellness in Mind and Body&quot; plus mental health referral (W-MH; N=20). The participants will&#xD;
      have clinically significant depressive symptoms (PHQ-9&gt;10) and will be older and middle-aged&#xD;
      adults (55+); 12.6% of the NYC senior center clients are aged 55-65 years. Clients will be&#xD;
      identified by senior center staff trained in SMART-MH strategies. The investigators will&#xD;
      offer additional training to staff of all centers on SMART-MH outreach, depression screening,&#xD;
      and treatment engagement. The investigators will train and provide weekly supervision to 2 or&#xD;
      more LCSWs per center of the two centers assigned to Engage-M. The investigators will not&#xD;
      offer training or supervision to senior center staff leading the groups of W-MH but will&#xD;
      provide oversight so that clients receive mental health referrals and are encouraged to&#xD;
      attend weekly Wellness group meetings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">June 9, 2020</completion_date>
  <primary_completion_date type="Actual">June 9, 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>Investigators will randomly assign four senior centers to offer either Engage-M (N=40), the treatment offered by REDS (1 individual and 8 weekly group sessions) or 8 group sessions &quot;Wellness in Mind and Body&quot; plus mental health referral (W-MH; N=20). Participants will have clinically significant depressive symptoms (PHQ-9&gt;10) and will be older and middle-aged adults (55+). Clients will be identified by senior center staff trained in SMART-MH strategies. Investigators will offer additional training to staff of all centers on SMART-MH outreach, depression screening, and treatment engagement. Investigators will train and provide weekly supervision to 2 or more LCSWs per center of the two centers assigned to Engage-M. Investigators will not offer training or supervision to senior center staff leading the groups of W-MH but will provide oversight so that clients receive mental health referrals and are encouraged to attend weekly Wellness group meetings.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 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-to document change in depressive symptoms.</time_frame>
    <description>In both conditions, the change in clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). The scale captures the severity of ten common symptoms of depression. The combined score yields a value between 0-60. Higher scores indicate more severe depression, which benchmarks as follows: 0 to 6: normal/symptoms absent; 7 to 19: mild depression; 20 to 34: moderate depression; &gt;34: severe depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in 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-to document change in assessment of quality of life.</time_frame>
    <description>In both conditions, change in assessment of quality of life is measured by the World Health Organization Quality of Life (WHOQOL) scale. This scale measures quality of life across four domains: 1) Physical Health 2) Psychological 3) Social relationships and 4) Environment. A higher score in any domain indicates a better outcome, and min/max values for each domain are as follows: 1) 7-35 2) 6-30 3) 3-15 4) 8-40.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Satisfaction With Study Intervention (CSQ)</measure>
    <time_frame>Assessed after REDS 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. The questionnaire comprises three questions, rated on a scale of 1-4. A higher score indicates a greater degree of client satisfaction.&#xD;
To what extent has the study therapist met your needs? 4=Almost all of my needs have been met 3=Most of my needs have been met 2=Some of my needs have been met 1=None of my needs have been met&#xD;
In an overall sense, how satisfied are you with the services that you have received? 4=Very satisfied 3=Mostly satisfied 2=Indifferent or mildly dissatisfied 1=Quite dissatisfied&#xD;
If you were to seek help again, would you come back to the study therapist you are currently seeing? 4=Yes, definitely 3=Yes, I think so 2=No, I don't think so 1=No, definitely not</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Depression, Unipolar</condition>
  <condition>Mental Health Disorder</condition>
  <arm_group>
    <arm_group_label>Engage-M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wellness in Mind and Body (W-MH)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Engage-M</intervention_name>
    <description>Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.</description>
    <arm_group_label>Engage-M</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness in Mind and Body</intervention_name>
    <description>An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s.</description>
    <arm_group_label>Wellness in Mind and Body (W-MH)</arm_group_label>
    <other_name>W-MH</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  55 years+&#xD;
&#xD;
          -  PHQ-9≥10&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
          -  MMSE ≥ 24&#xD;
&#xD;
          -  Capacity to provide written consent for both research assessment and the Engage-M&#xD;
             intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current active suicidal ideation defined by MADRS Suicide Item ≥ 4 (Probably better&#xD;
             off dead. Suicidal thoughts are common, and suicide is considered as a possible&#xD;
             solution, but without specific plans or intention).&#xD;
&#xD;
          -  Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression&#xD;
             pr generalized anxiety disorder by SCID-V.&#xD;
&#xD;
          -  Severe or life-threatening medical illness (e.g. end-stage organ failure).&#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 Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patricia Marino, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <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>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 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>October 17, 2022</last_update_submitted>
  <last_update_submitted_qc>October 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</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). The 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.&#xD;
The 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. To ensure data and participant security, investigators will make the data available to users only under a data-sharing agreement.</ipd_description>
    <ipd_time_frame>Per NIMH guidelines.</ipd_time_frame>
    <ipd_access_criteria>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.&#xD;
Findings will be reported in scientific meetings and publications promptly. Consistent with NIH policy, publications will be deposited at PubMed Central. The data from this research will be made available for integration with other datasets of 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>April 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03246789/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Engage-M</title>
          <description>Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.&#xD;
Engage-M: Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.</description>
        </group>
        <group group_id="P2">
          <title>Wellness in Mind and Body (W-MH)</title>
          <description>Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.&#xD;
Wellness in Mind and Body: An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s.</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="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Engage-M</title>
          <description>Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.&#xD;
Engage-M: Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.</description>
        </group>
        <group group_id="B2">
          <title>Wellness in Mind and Body (W-MH)</title>
          <description>Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.&#xD;
Wellness in Mind and Body: An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s.</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="15"/>
            <count group_id="B3" value="39"/>
          </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="71.88" spread="6.91"/>
                    <measurement group_id="B2" value="73.60" spread="7.40"/>
                    <measurement group_id="B3" value="72.54" spread="7.06"/>
                  </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="21"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </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="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="35"/>
                  </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="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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="34"/>
                  </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="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </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="24"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Clinically Significant Depressive Symptoms (MADRS)</title>
        <description>In both conditions, the change in clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). The scale captures the severity of ten common symptoms of depression. The combined score yields a value between 0-60. Higher scores indicate more severe depression, which benchmarks as follows: 0 to 6: normal/symptoms absent; 7 to 19: mild depression; 20 to 34: moderate depression; &gt;34: severe depression.</description>
        <time_frame>These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment-during the study-to document change in depressive symptoms.</time_frame>
        <population>Engage-M: Two participants completed only their baseline assessment. Additionally, two participants did not attend their Week-6 assessment, and one participant did not attend their Week-9 assessment.&#xD;
Wellness in Mind and Body (W-MH): One participant completed only their baseline assessment. Additionally, one participant did not attend their Week-6 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Engage-M</title>
            <description>Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.&#xD;
Engage-M: Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.</description>
          </group>
          <group group_id="O2">
            <title>Wellness in Mind and Body (W-MH)</title>
            <description>Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.&#xD;
Wellness in Mind and Body: An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Clinically Significant Depressive Symptoms (MADRS)</title>
          <description>In both conditions, the change in clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). The scale captures the severity of ten common symptoms of depression. The combined score yields a value between 0-60. Higher scores indicate more severe depression, which benchmarks as follows: 0 to 6: normal/symptoms absent; 7 to 19: mild depression; 20 to 34: moderate depression; &gt;34: severe depression.</description>
          <population>Engage-M: Two participants completed only their baseline assessment. Additionally, two participants did not attend their Week-6 assessment, and one participant did not attend their Week-9 assessment.&#xD;
Wellness in Mind and Body (W-MH): One participant completed only their baseline assessment. Additionally, one participant did not attend their Week-6 assessment.</population>
          <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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.21" spread="5.38"/>
                    <measurement group_id="O2" value="21" spread="3.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.5" spread="5.88"/>
                    <measurement group_id="O2" value="15.77" spread="6.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.86" spread="6.78"/>
                    <measurement group_id="O2" value="15.86" spread="4.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.36" spread="5.69"/>
                    <measurement group_id="O2" value="13.21" spread="6.25"/>
                  </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>0.31</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.09</ci_lower_limit>
            <ci_upper_limit>6.39</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Assessment of Quality of Life (WHO-QOL)</title>
        <description>In both conditions, change in assessment of quality of life is measured by the World Health Organization Quality of Life (WHOQOL) scale. This scale measures quality of life across four domains: 1) Physical Health 2) Psychological 3) Social relationships and 4) Environment. A higher score in any domain indicates a better outcome, and min/max values for each domain are as follows: 1) 7-35 2) 6-30 3) 3-15 4) 8-40.</description>
        <time_frame>These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment-during the study-to document change in assessment of quality of life.</time_frame>
        <population>Engage-M: Two participants completed only their baseline assessment. Additionally, two participants did not attend their Week-6 assessment, and one participant did not attend their Week-9 assessment.&#xD;
Wellness in Mind and Body (W-MH): One participant completed only their baseline assessment. Additionally, one participant did not attend their Week-6 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Engage-M</title>
            <description>Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.&#xD;
Engage-M: Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.</description>
          </group>
          <group group_id="O2">
            <title>Wellness in Mind and Body (W-MH)</title>
            <description>Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.&#xD;
Wellness in Mind and Body: An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Assessment of Quality of Life (WHO-QOL)</title>
          <description>In both conditions, change in assessment of quality of life is measured by the World Health Organization Quality of Life (WHOQOL) scale. This scale measures quality of life across four domains: 1) Physical Health 2) Psychological 3) Social relationships and 4) Environment. A higher score in any domain indicates a better outcome, and min/max values for each domain are as follows: 1) 7-35 2) 6-30 3) 3-15 4) 8-40.</description>
          <population>Engage-M: Two participants completed only their baseline assessment. Additionally, two participants did not attend their Week-6 assessment, and one participant did not attend their Week-9 assessment.&#xD;
Wellness in Mind and Body (W-MH): One participant completed only their baseline assessment. Additionally, one participant did not attend their Week-6 assessment.</population>
          <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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline - Domain 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.14" spread="4.10"/>
                    <measurement group_id="O2" value="20.87" spread="3.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Domain 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.81" spread="3.43"/>
                    <measurement group_id="O2" value="17.50" spread="3.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Domain 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.30" spread="2.62"/>
                    <measurement group_id="O2" value="9.36" spread="1.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Domain 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.00" spread="4.01"/>
                    <measurement group_id="O2" value="30.80" spread="3.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 - Domain 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.16" spread="3.78"/>
                    <measurement group_id="O2" value="21.00" spread="3.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 - Domain 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.00" spread="3.35"/>
                    <measurement group_id="O2" value="18.83" spread="2.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 - Domain 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.92" spread="2.14"/>
                    <measurement group_id="O2" value="9.00" spread="2.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 - Domain 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.42" spread="4.34"/>
                    <measurement group_id="O2" value="30.25" spread="5.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 - Domain 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.67" spread="2.37"/>
                    <measurement group_id="O2" value="22.08" spread="4.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 - Domain 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.19" spread="3.28"/>
                    <measurement group_id="O2" value="19.08" spread="4.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 - Domain 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.08" spread="2.68"/>
                    <measurement group_id="O2" value="10.00" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 - Domain 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.43" spread="4.04"/>
                    <measurement group_id="O2" value="29.69" spread="4.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 - Domain 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.68" spread="4.19"/>
                    <measurement group_id="O2" value="22.15" spread="3.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 - Domain 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.59" spread="3.84"/>
                    <measurement group_id="O2" value="18.46" spread="3.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 - Domain 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.69" spread="2.55"/>
                    <measurement group_id="O2" value="10.27" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 - Domain 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.18" spread="4.69"/>
                    <measurement group_id="O2" value="30.23" spread="5.33"/>
                  </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>0.28</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.22</ci_lower_limit>
            <ci_upper_limit>1.28</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>0.50</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.48</ci_lower_limit>
            <ci_upper_limit>1.74</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>0.02</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.88</ci_lower_limit>
            <ci_upper_limit>-0.28</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>0.98</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.63</ci_lower_limit>
            <ci_upper_limit>3.53</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Satisfaction With Study Intervention (CSQ)</title>
        <description>Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments. The questionnaire comprises three questions, rated on a scale of 1-4. A higher score indicates a greater degree of client satisfaction.&#xD;
To what extent has the study therapist met your needs? 4=Almost all of my needs have been met 3=Most of my needs have been met 2=Some of my needs have been met 1=None of my needs have been met&#xD;
In an overall sense, how satisfied are you with the services that you have received? 4=Very satisfied 3=Mostly satisfied 2=Indifferent or mildly dissatisfied 1=Quite dissatisfied&#xD;
If you were to seek help again, would you come back to the study therapist you are currently seeing? 4=Yes, definitely 3=Yes, I think so 2=No, I don't think so 1=No, definitely not</description>
        <time_frame>Assessed after REDS sessions completed at six, nine, and twelve weeks after study enrollment.</time_frame>
        <population>Engage-M: Two participants did not attend their Week-6 assessment, and one participant did not attend their Week-9 assessment.&#xD;
Wellness in Mind and Body (W-MH): One participant did not attend their Week-6 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Engage-M</title>
            <description>Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.&#xD;
Engage-M: Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.</description>
          </group>
          <group group_id="O2">
            <title>Wellness in Mind and Body (W-MH)</title>
            <description>Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.&#xD;
Wellness in Mind and Body: An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Satisfaction With Study Intervention (CSQ)</title>
          <description>Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments. The questionnaire comprises three questions, rated on a scale of 1-4. A higher score indicates a greater degree of client satisfaction.&#xD;
To what extent has the study therapist met your needs? 4=Almost all of my needs have been met 3=Most of my needs have been met 2=Some of my needs have been met 1=None of my needs have been met&#xD;
In an overall sense, how satisfied are you with the services that you have received? 4=Very satisfied 3=Mostly satisfied 2=Indifferent or mildly dissatisfied 1=Quite dissatisfied&#xD;
If you were to seek help again, would you come back to the study therapist you are currently seeing? 4=Yes, definitely 3=Yes, I think so 2=No, I don't think so 1=No, definitely not</description>
          <population>Engage-M: Two participants did not attend their Week-6 assessment, and one participant did not attend their Week-9 assessment.&#xD;
Wellness in Mind and Body (W-MH): One participant did not attend their Week-6 assessment.</population>
          <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="22"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 6 - #1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.80" spread="1.06"/>
                    <measurement group_id="O2" value="2.23" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 - #2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.35" spread="0.88"/>
                    <measurement group_id="O2" value="2.77" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 - #3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.50" spread="0.76"/>
                    <measurement group_id="O2" value="3.69" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 - #1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" spread="1.00"/>
                    <measurement group_id="O2" value="2.43" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 - #2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.57" spread="0.75"/>
                    <measurement group_id="O2" value="3.14" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 - #3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.70" spread="0.57"/>
                    <measurement group_id="O2" value="3.50" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 - #1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.68" spread="0.95"/>
                    <measurement group_id="O2" value="2.71" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 - #2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.18" spread="0.80"/>
                    <measurement group_id="O2" value="3.36" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 - #3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.68" spread="0.72"/>
                    <measurement group_id="O2" value="3.50" spread="0.76"/>
                  </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>0.92</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.64</ci_lower_limit>
            <ci_upper_limit>0.58</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>0.48</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.69</ci_lower_limit>
            <ci_upper_limit>0.33</ci_upper_limit>
          </analysis>
          <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>0.48</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.33</ci_lower_limit>
            <ci_upper_limit>0.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Each participant was monitored for adverse events for twelve weeks after the completion of their baseline assessment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Engage-M</title>
          <description>Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.&#xD;
Engage-M: Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.</description>
        </group>
        <group group_id="E2">
          <title>Wellness in Mind and Body (W-MH)</title>
          <description>Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.&#xD;
Wellness in Mind and Body: An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s.</description>
        </group>
      </group_list>
      <serious_events>
        <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="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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. Patricia Marino</name_or_title>
      <organization>Weill Cornell Institute of Geriatric Psychiatry</organization>
      <phone>(914) 997-8691</phone>
      <email>pam2029@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/NCT03246789
org study id: 1704018114
secondary id: P50MH113838
nct id: NCT03246789
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the feasibility of two types of group therapy sessions.
      The research is being done because the researchers are trying to learn if these approaches
      could be used by therapist in the community social service agencies to treat older adults
      with depression. There are two study groups. One group is a form of group therapy called
      "Engage-M", which encourages subjects to engage in physical and social activities that they
      find pleasurable or rewarding. One group is another form of group therapy called, "Wellness
      in Mind and Body", which focuses on education and de-stigmatization of health and mental
      health conditions.
In response to the large numbers of senior center clients who suffer from untreated
      depression, we have partnered with the NYC Department for the Aging (DFTA) to develop
      SMART-MH, a community care model that can be embedded in senior centers to improve
      recognition, referral, and adherence to depression treatment. The investigators also
      developed and tested Engage, a stepped-care therapy streamlined to use "reward exposure" as
      its principal intervention based on the assumption that dysfunction of the reward networks is
      central to the pathogenesis of depression. With senior center partners and a mobile
      technology team, the investigators redesigned Engage-M so that it can be used in a group
      format by licensed clinical social workers (LCSWs) of Senior Centers. Mobile technology
      provides probes for client adherence and offers to therapists easy to review summary records
      of mood, activity, and social interaction that can be used to target their sessions. The
      investigators have integrated SMART-MH and Engage-M into a comprehensive community care model
      "Reaching and Engaging Depressed Senior Center Clients" (REDS).

      The specific aims of this developmental project are to: 1. Finalize the REDS protocol and
      assess feasibility of training; 2. Prepare an Operations' Manual; 3. Examine reach,
      feasibility, and acceptability of REDS; 4. Examine engagement of behavioral targets and
      preliminary effectiveness; and 5. Collect information on REDS cost, barriers to
      implementation, and potential savings in health care utilization.

      The investigators will randomly assign four senior centers to offer either Engage-M (N=40),
      the treatment offered by REDS (1 individual and 8 weekly group sessions) or 8 group sessions
      "Wellness in Mind and Body" plus mental health referral (W-MH; N=20). The participants will
      have clinically significant depressive symptoms (PHQ-9>10) and will be older and middle-aged
      adults (55+); 12.6% of the NYC senior center clients are aged 55-65 years. Clients will be
      identified by senior center staff trained in SMART-MH strategies. The investigators will
      offer additional training to staff of all centers on SMART-MH outreach, depression screening,
      and treatment engagement. The investigators will train and provide weekly supervision to 2 or
      more LCSWs per center of the two centers assigned to Engage-M. The investigators will not
      offer training or supervision to senior center staff leading the groups of W-MH but will
      provide oversight so that clients receive mental health referrals and are encouraged to
      attend weekly Wellness group meetings.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Investigators will randomly assign four senior centers to offer either Engage-M (N=40), the treatment offered by REDS (1 individual and 8 weekly group sessions) or 8 group sessions "Wellness in Mind and Body" plus mental health referral (W-MH; N=20). Participants will have clinically significant depressive symptoms (PHQ-9>10) and will be older and middle-aged adults (55+). Clients will be identified by senior center staff trained in SMART-MH strategies. Investigators will offer additional training to staff of all centers on SMART-MH outreach, depression screening, and treatment engagement. Investigators will train and provide weekly supervision to 2 or more LCSWs per center of the two centers assigned to Engage-M. Investigators will not offer training or supervision to senior center staff leading the groups of W-MH but will provide oversight so that clients receive mental health referrals and are encouraged to attend weekly Wellness group meetings.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in 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-to document change in depressive symptoms.
description: In both conditions, the change in clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). The scale captures the severity of ten common symptoms of depression. The combined score yields a value between 0-60. Higher scores indicate more severe depression, which benchmarks as follows: 0 to 6: normal/symptoms absent; 7 to 19: mild depression; 20 to 34: moderate depression; >34: severe depression.
measure: Change in 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-to document change in assessment of quality of life.
description: In both conditions, change in assessment of quality of life is measured by the World Health Organization Quality of Life (WHOQOL) scale. This scale measures quality of life across four domains: 1) Physical Health 2) Psychological 3) Social relationships and 4) Environment. A higher score in any domain indicates a better outcome, and min/max values for each domain are as follows: 1) 7-35 2) 6-30 3) 3-15 4) 8-40.
measure: Change in Satisfaction With Study Intervention (CSQ)
time frame: Assessed after REDS 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. The questionnaire comprises three questions, rated on a scale of 1-4. A higher score indicates a greater degree of client satisfaction.
To what extent has the study therapist met your needs? 4=Almost all of my needs have been met 3=Most of my needs have been met 2=Some of my needs have been met 1=None of my needs have been met
In an overall sense, how satisfied are you with the services that you have received? 4=Very satisfied 3=Mostly satisfied 2=Indifferent or mildly dissatisfied 1=Quite dissatisfied
If you were to seek help again, would you come back to the study therapist you are currently seeing? 4=Yes, definitely 3=Yes, I think so 2=No, I don't think so 1=No, definitely not
arm group label: Engage-M
arm group type: Experimental
description: Participants will meet individually with a therapist once before beginning weekly group sessions for eight weeks. Each weekly session will last approximately 50 minutes. Study investigators have trained Engage-M therapists to provide participants with a group therapy approach called Engage-M. During the weekly therapy sessions, therapists will encourage participants to engage in physical and social activities that you find pleasurable or rewarding.
arm group label: Wellness in Mind and Body (W-MH)
arm group type: Active Comparator
description: Participants will meet with a therapist for group therapy once a week for eight weeks. Each weekly session will last approximately 50 minutes. During these weekly sessions, the therapist will educate participants about health and mental health.
intervention type: Behavioral
intervention name: Engage-M
description: Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.
arm group label: Engage-M
intervention type: Behavioral
intervention name: Wellness in Mind and Body
description: An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s.
arm group label: Wellness in Mind and Body (W-MH)
other name: W-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 Medical College of Cornell University
last name: Patricia Marino, PhD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mental Disorders
mesh term: Depressive Disorder
sharing ipd: Yes
ipd description: The Center will share its data via the NIMH Data Archive (NDA). The 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.
The 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. To ensure data and participant security, investigators will make the data available to users only under a data-sharing agreement.
ipd time frame: Per NIMH guidelines.
ipd access criteria: 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.
Findings will be reported in scientific meetings and publications promptly. Consistent with NIH policy, publications will be deposited at PubMed Central. The data from this research will be made available for integration with other datasets of the ALACRITY Center.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 