<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/NCT02229188</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001751</org_study_id>
    <nct_id>NCT02229188</nct_id>
  </id_info>
  <brief_title>Games to Overcome Late Life Depression</brief_title>
  <acronym>GOLD</acronym>
  <official_title>Games to Overcome Late Life Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study divided into two phases. IN phase 1 (completed) participants will be&#xD;
      randomized to receive 8 weeks of Problem Solving Therapy (PST) alone or 8 weeks of a&#xD;
      cognitive training game called, Evolution (Evo) plus clinical management. In Phase 2 (now&#xD;
      recruiting), participants will be randomized to Evo, PST, and a different cognitive training&#xD;
      program called Words. Words is similar to Evo in that it is an adaptive training program and&#xD;
      includes case management. IN both studies participants will be assessed for clinical and&#xD;
      functional magnetic resonance imaging (fMRI) outcomes at baseline, 4 weeks and 8 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evo is a computer game that targets parts of the brain (i.e. the cognitive control network)&#xD;
      that we think may be associated with depressive symptoms. This study is exploratory and will&#xD;
      inform future hypotheses the research team will test in subsequent research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2013</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in depression over time</measure>
    <time_frame>weeks 0, 4, 8, 24</time_frame>
    <description>Hamilton Depression Rating Scale</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Problem Solving Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Problem Solving Therapy is an evidence-based behavioral treatment for late life depression proven effective with different geriatric groups including ambulatory; medically ill; older adults with executive dysfunctions; and more recently, low-income, disabled older adults.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evolution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evolution is a plasticity intervention in the form of a video driving game that targets the cognitive conflict network.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Words</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Words is a challenging crosswords type of game that will serve as the placebo comparator to Evo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Problem Solving Therapy</intervention_name>
    <description>Problem solving therapy is an evidence based behavioral intervention for late life depression. It consist of 8 weekly session of talk therapy, whereby the therapist helps the patient solve problems that are thought to be causing depressive symptoms.</description>
    <arm_group_label>Problem Solving Therapy</arm_group_label>
    <other_name>PST</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Evolution</intervention_name>
    <description>Evo is a video game that has therapeutic elements targeting the cognitive control network. Impairment in this neural network is associated with a specific subtype of late life depression that puts people at risk for poor response to SSRIs. Evo is built from a research grade training paradigm that has shown to induce improvements in this network in healthy older adults</description>
    <arm_group_label>Evolution</arm_group_label>
    <other_name>Neuroracer</other_name>
    <other_name>Evo</other_name>
    <other_name>Project: Evolution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Words</intervention_name>
    <description>Words is a cognitively challenging crossword/word search type of video game that will serve as the control condition for the second phase of this project</description>
    <arm_group_label>Words</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 60-80 years of age&#xD;
&#xD;
          2. Meets criteria for Major Depressive Disorder&#xD;
&#xD;
          3. Hamilton Depression Rating Scale (HDRS) of 20 or greater&#xD;
&#xD;
          4. Mini Mental State Exam score of 24 or greater&#xD;
&#xD;
          5. Can speak and read English&#xD;
&#xD;
          6. Able to physically participate in the research protocol (e.g.: is not suffering from a&#xD;
             terminal or highly disabling illness)&#xD;
&#xD;
          7. Can participate in MRI scans&#xD;
&#xD;
          8. Able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of psychosis, mania, or currently using or abusing illicit drugs or alcohol&#xD;
&#xD;
          2. Diagnosis of dementia&#xD;
&#xD;
          3. Taking cognitive enhancers&#xD;
&#xD;
          4. Change in or newly began taking psychiatric medication within the last 6 months&#xD;
&#xD;
          5. Pacemaker&#xD;
&#xD;
          6. Metal in the body that cannot be removed&#xD;
&#xD;
          7. Color blind&#xD;
&#xD;
          8. Movement disorder that prevents participation -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia Arean, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Washington Department of Psychiatry and Behavioral Sciences</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>September 18, 2018</last_update_submitted>
  <last_update_submitted_qc>September 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Pat Arean</investigator_full_name>
    <investigator_title>Professor, Psychiatry and Behavioral Sciences</investigator_title>
  </responsible_party>
  <keyword>Depression; mood; cognitive training</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>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <!-- 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/NCT02229188
org study id: STUDY00001751
nct id: NCT02229188
lead sponsor: 
has dmc: No
This is a pilot study divided into two phases. IN phase 1 (completed) participants will be
      randomized to receive 8 weeks of Problem Solving Therapy (PST) alone or 8 weeks of a
      cognitive training game called, Evolution (Evo) plus clinical management. In Phase 2 (now
      recruiting), participants will be randomized to Evo, PST, and a different cognitive training
      program called Words. Words is similar to Evo in that it is an adaptive training program and
      includes case management. IN both studies participants will be assessed for clinical and
      functional magnetic resonance imaging (fMRI) outcomes at baseline, 4 weeks and 8 weeks.
Evo is a computer game that targets parts of the brain (i.e. the cognitive control network)
      that we think may be associated with depressive symptoms. This study is exploratory and will
      inform future hypotheses the research team will test in subsequent research.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Change in depression over time
time frame: weeks 0, 4, 8, 24
description: Hamilton Depression Rating Scale
arm group label: Problem Solving Therapy
arm group type: Active Comparator
description: Problem Solving Therapy is an evidence-based behavioral treatment for late life depression proven effective with different geriatric groups including ambulatory; medically ill; older adults with executive dysfunctions; and more recently, low-income, disabled older adults.
arm group label: Evolution
arm group type: Experimental
description: Evolution is a plasticity intervention in the form of a video driving game that targets the cognitive conflict network.
arm group label: Words
arm group type: Placebo Comparator
description: Words is a challenging crosswords type of game that will serve as the placebo comparator to Evo.
intervention type: Behavioral
intervention name: Problem Solving Therapy
description: Problem solving therapy is an evidence based behavioral intervention for late life depression. It consist of 8 weekly session of talk therapy, whereby the therapist helps the patient solve problems that are thought to be causing depressive symptoms.
arm group label: Problem Solving Therapy
other name: PST
intervention type: Behavioral
intervention name: Evolution
description: Evo is a video game that has therapeutic elements targeting the cognitive control network. Impairment in this neural network is associated with a specific subtype of late life depression that puts people at risk for poor response to SSRIs. Evo is built from a research grade training paradigm that has shown to induce improvements in this network in healthy older adults
arm group label: Evolution
other name: Neuroracer
other name: Evo
other name: Project: Evolution
intervention type: Behavioral
intervention name: Words
description: Words is a cognitively challenging crossword/word search type of video game that will serve as the control condition for the second phase of this project
arm group label: Words
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Patricia Arean, PhD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Pat Arean
investigator title: Professor, Psychiatry and Behavioral Sciences
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major