<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/NCT01698255</url>
  </required_header>
  <id_info>
    <org_study_id>1108011880</org_study_id>
    <secondary_id>11108011880</secondary_id>
    <secondary_id>P30MH085943-05</secondary_id>
    <nct_id>NCT01698255</nct_id>
  </id_info>
  <brief_title>Psychotherapy for Late Life Depression</brief_title>
  <acronym>ENGAGE-II</acronym>
  <official_title>Psychotherapy for Late Life Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized pilot study will test the feasibility of a behavioral intervention for late&#xD;
      life depression. Enrolled participants will receive 9 weeks of a specialized form of&#xD;
      psychotherapy we call &quot;ENGAGE&quot; or standard of care psychotherapy. ENGAGE is a stepped care&#xD;
      psychotherapy based on what is currently known about older adults' response to depression&#xD;
      interventions. Stepped care is a model of treatment that starts with the minimum effective&#xD;
      therapeutic techniques first, and then based on how well people respond to treatment,&#xD;
      additional therapeutic techniques are added until individuals recover from their depression.&#xD;
      The treatment components of ENGAGE were selected to match the most common problems seen in&#xD;
      older adults with depression. They include instructing the participant in basic problem&#xD;
      solving techniques and encouraging re-engagement in rewarding activities.&#xD;
&#xD;
      Participants will be depressed, older adult clients of Westchester Jewish Community Services&#xD;
      or outpatient research subjects recruited by the Cornell Institute of Geriatric Psychiatry.&#xD;
      In addition to receiving therapy, study participants will also undergo research assessments&#xD;
      at the beginning of the study and then at weeks 6 and 9.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A concern about existing psychotherapies is that, while effective in depression, community&#xD;
      clinicians find them difficult to implement in older people, particularly those with medical&#xD;
      illnesses or disability. As a consequence evidence-based psychotherapies are utilized by a&#xD;
      small number of specialized clinicians and offered to small number of select patients.&#xD;
&#xD;
      ENGAGE approaches these problems with a four prong strategy: 1) It developed a brief&#xD;
      treatment program consisting of psychotherapeutic components of known efficacy. 2) Among&#xD;
      them, ENGAGE selected components most pertinent to older adults. 3) ENGAGE distilled and&#xD;
      simplified these components so that they can be accessible to most depressed older patients&#xD;
      and taught to large numbers of clinicians. 4) To further simplify and personalize its&#xD;
      administration, ENGAGE relies on a stepped approach focusing on engagement in rewarding&#xD;
      social and physical activities (a form of behavioral activation), and when needed, adding&#xD;
      techniques for management of emotionality (emotional control), negativity bias, and apathy.&#xD;
      The self-correcting and least restrictive nature of stepped care approaches has appeal from&#xD;
      patient cost/time efficiency and personalized treatment perspective. This project aims to&#xD;
      further develop ENGAGE, to study the feasibility of training professionals (master's level&#xD;
      social workers) offering care to depressed elderly patients in the community, to obtain&#xD;
      preliminary data of its efficacy compared to community-based therapy (CT), and to prepare for&#xD;
      an effectiveness (R01) study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Depression</measure>
    <time_frame>3 months</time_frame>
    <description>To compare the effectiveness of the ENGAGE intervention in reducing depressive symptoms with that of the standard of care psychotherapy. We will assess severity of depression at Baseline. 6 weeks and 3 months using the Hamilton Depression Rating Scale as the primary measure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>ENGAGE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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. The steps of ENGAGE are:&#xD;
basic social and physical engagement, which has been found to be a very effective depression strategy for most older adults;&#xD;
the addition of strategies to address clinical features of depression interfering with treatment engagement, namely affect regulation, pessimism, and disorganization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Psychotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The comparison group for this study will be the current standard of care psychotherapy offered by Westchester Jewish Community Services (WJCS) therapists. This type of psychotherapy is often supportive or eclectic in nature. Therapists will focus on helping the subject to express feelings and focus on strengths and abilities in working through current difficulties and transitions. Therapists assigned to provide standard psychotherapy to eligible participants will receive training and supervision from WJCS staff consistent with agency practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ENGAGE</intervention_name>
    <arm_group_label>ENGAGE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care Psychotherapy</intervention_name>
    <arm_group_label>Standard of Care Psychotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (WJCS Participants):&#xD;
&#xD;
          -  Current client of Westchester Jewish Community Services;&#xD;
&#xD;
          -  Age 60 years or older;&#xD;
&#xD;
          -  Diagnosis of depression as determined by WJCS therapists;&#xD;
&#xD;
          -  Command of English sufficient to participate in talking therapy;&#xD;
&#xD;
        Inclusion Criteria (Cornell Participants):&#xD;
&#xD;
          -  Age 60 years or older;&#xD;
&#xD;
          -  Depression as determined by a Patient Health Questionnaire-9 score of 6 or higher&#xD;
             (with at least one item being &quot;depressed mood&quot; or &quot;loss of interest/pleasure&quot;);&#xD;
&#xD;
          -  Command of English sufficient to participate in talking therapy;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia: Mini Mental State Exam score below 24 or clinical diagnosis of dementia by&#xD;
             Diagnostic and Statistical Manual IV;&#xD;
&#xD;
          -  High suicide risk, i.e. intent or plan to attempt suicide in near future;&#xD;
&#xD;
          -  History of psychiatric diagnoses other than major depressive disorder or generalized&#xD;
             anxiety disorder (including bi-polar depression, psychotic depression, schizoaffective&#xD;
             disorders).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Alexopoulos, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Westchester Jewish Community Services</name>
      <address>
        <city>Hartsdale</city>
        <state>New York</state>
        <zip>10530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>February 17, 2017</last_update_submitted>
  <last_update_submitted_qc>February 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Geriatrics</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>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01698255
org study id: 1108011880
secondary id: 11108011880
secondary id: P30MH085943-05
nct id: NCT01698255
lead sponsor: 
collaborator: 
has dmc: Yes
This randomized pilot study will test the feasibility of a behavioral intervention for late
      life depression. Enrolled participants will receive 9 weeks of a specialized form of
      psychotherapy we call "ENGAGE" or standard of care psychotherapy. ENGAGE is a stepped care
      psychotherapy based on what is currently known about older adults' response 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 individuals recover from their depression.
      The treatment components of ENGAGE were selected to match the most common problems seen in
      older adults with depression. They include instructing the participant in basic problem
      solving techniques and encouraging re-engagement in rewarding activities.

      Participants will be depressed, older adult clients of Westchester Jewish Community Services
      or outpatient research subjects recruited by the Cornell Institute of Geriatric Psychiatry.
      In addition to receiving therapy, study participants will also undergo research assessments
      at the beginning of the study and then at weeks 6 and 9.
A concern about existing psychotherapies is that, while effective in depression, community
      clinicians find them difficult to implement in older people, particularly those with medical
      illnesses or disability. As a consequence evidence-based psychotherapies are utilized by a
      small number of specialized clinicians and offered to small number of select patients.

      ENGAGE approaches these problems with a four prong strategy: 1) It developed a brief
      treatment program consisting of psychotherapeutic components of known efficacy. 2) Among
      them, ENGAGE selected components most pertinent to older adults. 3) ENGAGE distilled and
      simplified these components so that they can be accessible to most depressed older patients
      and taught to large numbers of clinicians. 4) To further simplify and personalize its
      administration, ENGAGE relies on a stepped approach focusing on engagement in rewarding
      social and physical activities (a form of behavioral activation), and when needed, adding
      techniques for management of emotionality (emotional control), negativity bias, and apathy.
      The self-correcting and least restrictive nature of stepped care approaches has appeal from
      patient cost/time efficiency and personalized treatment perspective. This project aims to
      further develop ENGAGE, to study the feasibility of training professionals (master's level
      social workers) offering care to depressed elderly patients in the community, to obtain
      preliminary data of its efficacy compared to community-based therapy (CT), and to prepare for
      an effectiveness (R01) study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Depression
time frame: 3 months
description: To compare the effectiveness of the ENGAGE intervention in reducing depressive symptoms with that of the standard of care psychotherapy. We will assess severity of depression at Baseline. 6 weeks and 3 months using the Hamilton Depression Rating Scale as the primary measure.
arm group label: ENGAGE
arm group type: Experimental
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. The steps of ENGAGE are:
basic social and physical engagement, which has been found to be a very effective depression strategy for most older adults;
the addition of strategies to address clinical features of depression interfering with treatment engagement, namely affect regulation, pessimism, and disorganization.
arm group label: Standard of Care Psychotherapy
arm group type: Active Comparator
description: The comparison group for this study will be the current standard of care psychotherapy offered by Westchester Jewish Community Services (WJCS) therapists. This type of psychotherapy is often supportive or eclectic in nature. Therapists will focus on helping the subject to express feelings and focus on strengths and abilities in working through current difficulties and transitions. Therapists assigned to provide standard psychotherapy to eligible participants will receive training and supervision from WJCS staff consistent with agency practice.
intervention type: Behavioral
intervention name: ENGAGE
arm group label: ENGAGE
intervention type: Behavioral
intervention name: Standard of Care Psychotherapy
arm group label: Standard of Care Psychotherapy
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: George Alexopoulos, M.D.
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: No