<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/NCT04487730</url>
  </required_header>
  <id_info>
    <org_study_id>20-04021860</org_study_id>
    <secondary_id>K23MH123864-01</secondary_id>
    <nct_id>NCT04487730</nct_id>
  </id_info>
  <brief_title>Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression</brief_title>
  <official_title>Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abnormalities in the Positive Valence System (PVS) are associated with depressive symptoms&#xD;
      and reduced behavioral activation in mid- and late-life. This study will investigate the&#xD;
      engagement of the PVS during exposure to social rewards, part of a novel streamlined&#xD;
      psychotherapy for mid- and late-life depression. Use of computational modeling will enable&#xD;
      identification of neuroimaging and behavioral profiles associated with greater treatment&#xD;
      response, and may guide future personalization of psychotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 15, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2025</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>This is a randomized controlled trial. Participants will be randomly assigned to 9-weeks of either &quot;Engage-S&quot; Psychotherapy or &quot;Symptom Review and Psychoeducation&quot; (SRP) Psychotherapy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Resting State fMRI Connectivity of the Positive Valence System</measure>
    <time_frame>Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)</time_frame>
    <description>Calculated from fMRI scan. Validation of target engagement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Montgomery Asberg Depression Rating Scale (MADRS)</measure>
    <time_frame>Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)</time_frame>
    <description>10-item Clinician rated measure of depression severity. Scores range from 0 (no depression) to 60 (severe depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Behavioral Activation for Depression Scale (BADS)</measure>
    <time_frame>Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)</time_frame>
    <description>25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>&quot;Engage &amp; Connect&quot; Psychotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;Engage &amp; Connect&quot;, a modified adapted version of &quot;Engage&quot;. Its principal intervention is &quot;social reward exposure&quot; - facilitating engagement in rewarding and meaningful social activities with significant others. In &quot;Engage-S&quot; therapy, individuals with depression work with a therapist to develop &quot;action plans&quot; to pursue rewarding social activities of their choice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Symptom Review and Psychoeducation (SRP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>&quot;Engage &amp; Connect&quot; Psychotherapy</intervention_name>
    <description>9-weeks of weekly psychotherapy sessions focused on social reward exposure</description>
    <arm_group_label>&quot;Engage &amp; Connect&quot; Psychotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Symptom Review and Psychoeducation (SRP)</intervention_name>
    <description>9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging</description>
    <arm_group_label>Symptom Review and Psychoeducation (SRP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ages aged 50-85 [stratified so that 50% are older than 65]&#xD;
&#xD;
          2. Diagnosis of unipolar major depressive disorder without psychotic features, determined&#xD;
             by the SCID&#xD;
&#xD;
          3. Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 20.&#xD;
&#xD;
          4. Mini Mental Status Exam (MMSE) ≤ 1 SD below the mean score for patient's age and&#xD;
             education&#xD;
&#xD;
          5. Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not&#xD;
             intend to change the dose in the next 10 weeks.&#xD;
&#xD;
          6. Capacity to provide written consent for research assessment and treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Intent or plan to attempt suicide in the near future.&#xD;
&#xD;
          2. History or presence of psychiatric diagnoses other than major depressive disorder&#xD;
             without psychotic features, generalized anxiety disorder, or specific phobia.&#xD;
&#xD;
          3. Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of&#xD;
             lorazepam daily up to seven times per week.&#xD;
&#xD;
          4. Neurological disorders (dementias, history of stroke, multiple sclerosis, Parkinson's&#xD;
             disease, epilepsy, etc.); cardiac, renal, or respiratory failure; severe chronic&#xD;
             obstructive pulmonary disease; metastatic cancer; or debilitated states or less common&#xD;
             medical illnesses that may either influence brain systems of interest or ability to&#xD;
             participate in the study. Dr. Alexopoulos or another research psychiatrist will review&#xD;
             any medical illnesses that does not appear in the list above and determine whether it&#xD;
             interferes with the study of positive valence system functions in depression.&#xD;
&#xD;
          5. Contraindications to MRI scanning including cardiac pacemaker, heart valve&#xD;
             replacement, vascular stent, insulin pump, cochlear implant, any other metallic&#xD;
             biomedical implant contraindicating to MRI, and claustrophobia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nili Solomonov, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nili Solomonov, PhD</last_name>
    <phone>914-682-9100</phone>
    <phone_ext>1012497</phone_ext>
    <email>nis2051@med.cornell.edu</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Nili Solomonov, PhD</last_name>
      <phone>914-682-9100</phone>
      <phone_ext>1012497</phone_ext>
      <email>nis2051@med.cornell.edu</email>
    </contact>
    <investigator>
      <last_name>Nili Solomonov, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Late Life Depression</keyword>
  <keyword>Psychotherapy</keyword>
  <keyword>Mechanisms of Action</keyword>
  <keyword>Positive Valence System</keyword>
  <keyword>Social Reward</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in publications, after de-identification, as well as study protocol, treatment manuals, statistical analysis plan and informed consent. We will also share our fMRI tasks and analytic code by request with all interested researchers.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After we publish the main results, we will make de-identified data available to other researchers, under a data-sharing agreement overseen by the Weill Cornell ALACRITY Center's Executive Committee.</ipd_time_frame>
    <ipd_access_criteria>Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. All researchers requesting data will commit to using the data solely for research purpose; secure the data; return or destroy it once analyses are completed; do not share it with other researchers.</ipd_access_criteria>
  </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/NCT04487730
org study id: 20-04021860
secondary id: K23MH123864-01
nct id: NCT04487730
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Abnormalities in the Positive Valence System (PVS) are associated with depressive symptoms
      and reduced behavioral activation in mid- and late-life. This study will investigate the
      engagement of the PVS during exposure to social rewards, part of a novel streamlined
      psychotherapy for mid- and late-life depression. Use of computational modeling will enable
      identification of neuroimaging and behavioral profiles associated with greater treatment
      response, and may guide future personalization of psychotherapy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized controlled trial. Participants will be randomly assigned to 9-weeks of either "Engage-S" Psychotherapy or "Symptom Review and Psychoeducation" (SRP) Psychotherapy
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Resting State fMRI Connectivity of the Positive Valence System
time frame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)
description: Calculated from fMRI scan. Validation of target engagement.
measure: Change in Montgomery Asberg Depression Rating Scale (MADRS)
time frame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)
description: 10-item Clinician rated measure of depression severity. Scores range from 0 (no depression) to 60 (severe depression).
measure: Change in Behavioral Activation for Depression Scale (BADS)
time frame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)
description: 25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation).
arm group label: "Engage & Connect" Psychotherapy
arm group type: Experimental
description: "Engage & Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.
arm group label: Symptom Review and Psychoeducation (SRP)
arm group type: Active Comparator
description: In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.
intervention type: Behavioral
intervention name: "Engage & Connect" Psychotherapy
description: 9-weeks of weekly psychotherapy sessions focused on social reward exposure
arm group label: "Engage & Connect" Psychotherapy
intervention type: Behavioral
intervention name: Symptom Review and Psychoeducation (SRP)
description: 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging
arm group label: Symptom Review and Psychoeducation (SRP)
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Nili Solomonov, PhD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: Nili Solomonov, PhD
phone: 914-682-9100
phone ext: 1012497
email: nis2051@med.cornell.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in publications, after de-identification, as well as study protocol, treatment manuals, statistical analysis plan and informed consent. We will also share our fMRI tasks and analytic code by request with all interested researchers.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: After we publish the main results, we will make de-identified data available to other researchers, under a data-sharing agreement overseen by the Weill Cornell ALACRITY Center's Executive Committee.
ipd access criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. All researchers requesting data will commit to using the data solely for research purpose; secure the data; return or destroy it once analyses are completed; do not share it with other researchers.