<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/NCT03043573</url>
  </required_header>
  <id_info>
    <org_study_id>1603017114</org_study_id>
    <secondary_id>1R01AG050514</secondary_id>
    <nct_id>NCT03043573</nct_id>
  </id_info>
  <brief_title>Problem Adaptation Therapy for Mild Cognitive Impairment and Depression</brief_title>
  <acronym>PATH-MCI</acronym>
  <official_title>Problem Adaptation Therapy for Mild Cognitive Impairment and Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</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 present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare&#xD;
      Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs.&#xD;
      Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive,&#xD;
      affective, and functioning outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare&#xD;
      Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs.&#xD;
      Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive,&#xD;
      affective and functioning outcomes. Psychotherapy, also known as talking therapy, is the use&#xD;
      of psychological methods to help a person change and overcome problems in desired ways.&#xD;
      PATH-MCI differs from standard of care psychotherapy by offering a combination of emotion&#xD;
      regulation techniques with the provision of environmental adaptation tools (notes,&#xD;
      checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing&#xD;
      and available caregiver. Supportive Therapy incorporates standard of care approaches by using&#xD;
      non-specific techniques to provide a supportive environment and help patients to express&#xD;
      their feelings &amp; focus on their strengths and abilities.&#xD;
&#xD;
      The investigators plan to randomize 80 treatment subjects, older adults (40 at Cornell and 40&#xD;
      at Johns Hopkins) with MCI-depression. 80 study partners may also be potentially recruited.&#xD;
      Both sites have shown feasibility of recruitment, randomization, retention, and assessment&#xD;
      procedures for patients with MCI. Cornell has shown evidence of administration of PATH in&#xD;
      this population. Certified mental health clinicians in PATH-MCI and ST-CI will administer 15&#xD;
      in-office sessions in six months.&#xD;
&#xD;
      The investigators propose to compare the effects of 15 sessions (12 weekly in first 12 weeks&#xD;
      and 3 monthly booster sessions afterwards) of PATH-MCI vs. ST-CI in 80 older adults&#xD;
      (treatment subjects) with MCI-depression. Research assistants, unaware of study hypotheses&#xD;
      and participant randomization status, will perform research assessments at baseline and at 6&#xD;
      (no cognitive measures), 12, 24, 36 (no cognitive measures) and 52 weeks after randomization.&#xD;
&#xD;
      There will also be optional blood draws at study entry, 12, and 52 weeks. The purpose of the&#xD;
      blood draws is to better understand whether response to psychotherapy treatment is affected&#xD;
      by genes, by inflammation, or by the possible memory factor called BDNF (brain-derived&#xD;
      neurotrophic factor). Also, all therapy sessions will be audiotaped (if the patient consents)&#xD;
      and Dr. Shermer (a clinician outside of the Weill Cornell Institute of Geriatric Psychiatry)&#xD;
      will evaluate randomly selected sessions and rate the therapists' adherence and competence&#xD;
      based on the PATH-MCI and ST Adherence Scales&#xD;
&#xD;
      The study partner will provide information about the treatment subject and participate in&#xD;
      treatment if agreed by the treatment subject. To explore the effects of PATH-MCI on the study&#xD;
      partner, the investigators will collect the following data from the study partner:&#xD;
      demographic, burden (Short Zarit Burden interview), and treatment satisfaction (Client&#xD;
      Satisfaction Questionnaire).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2023</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Global Cognition assessed by RBANS</measure>
    <time_frame>Baseline, 12, 24, and 52 Weeks</time_frame>
    <description>Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in disability function assessed with WHODAS-II</measure>
    <time_frame>Baseline, 6, 12, 24, 36, and 52 Weeks</time_frame>
    <description>Disability function, as measured by the World Health Organization Disability Assessment Schedule-II (WHODAS-II) Total score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression assessed by MADRS</measure>
    <time_frame>Baseline, 6, 12, 24, 36, and 52 Weeks</time_frame>
    <description>Depression assessed by Montgomery Asberg Depression Rating Scale (MADRS) Total Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Episodic Memory assessed by subscale of RBANS</measure>
    <time_frame>Baseline, 12, 24, and 52 Weeks</time_frame>
    <description>Delayed Recall subscale of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Executive Function assessed by Trail Making Test</measure>
    <time_frame>Baseline, 12, 24, and 52 Weeks</time_frame>
    <description>Trail Making Test</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Stress Reduction assessed by Perceived Stress Scale</measure>
    <time_frame>Baseline, 6, 12, 24, 36, and 52 Weeks</time_frame>
    <description>Perceived Stress Scale</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Cognitive Impairment</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>PATH-MCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supportive Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Supportive Therapy focuses on: 1. Facilitating expression of affect; 2. Conveying to the patient that he or she is understood; 3. Offering empathy; and 4. Highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PATH-MCI</intervention_name>
    <description>Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.</description>
    <arm_group_label>PATH-MCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supportive Therapy</intervention_name>
    <description>ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.</description>
    <arm_group_label>Supportive Therapy</arm_group_label>
    <other_name>ST</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Amnestic MCI as defined by Albert et al&#xD;
&#xD;
          -  Montgomery Asberg Depression Rating Scale (MADRS) greater than 7 and MADRS total less&#xD;
             than 30&#xD;
&#xD;
          -  Participants will be off antidepressants, cholinesterase inhibitors or memantine, or&#xD;
             on a stable dosage for at least 12 weeks without any medical recommendation to adjust&#xD;
             dosage in next 3 months (during treatment)&#xD;
&#xD;
          -  Clinical Dementia Rating (CDR) = 0.5 at screening&#xD;
&#xD;
          -  Subjects will have capacity to consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Deemed to have a significant suicide risk as assessed by site PI and clinical team&#xD;
&#xD;
          -  Deemed too unstable medically or neurologically to safely enroll in a research trial&#xD;
&#xD;
          -  Deemed too psychiatrically unstable to safely enroll in randomized trial of&#xD;
             psychotherapy. Requiring psychiatric hospitalization at baseline for safety.&#xD;
&#xD;
          -  Current involvement in psychotherapy&#xD;
&#xD;
          -  Lack of English fluency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dimitris Kiosses, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dimitris Kiosses, PhD</last_name>
    <phone>9149974381</phone>
    <email>dkiosses@med.cornell.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laurie Evans, MS</last_name>
    <phone>9146829100</phone>
    <phone_ext>1012570</phone_ext>
    <email>lad9011@med.cornell.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Johns Hopkins University School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paul B Rosenberg, MD</last_name>
      <phone>410-550-9883</phone>
      <email>prosenb9@jhmi.edu</email>
    </contact>
    <contact_backup>
      <last_name>Samantha Horn</last_name>
      <phone>410-550-9022</phone>
      <email>shorn8@jhmi.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dimitris Kiosses, PhD</last_name>
      <phone>914-997-4381</phone>
      <email>dkiosses@med.cornell.edu</email>
    </contact>
    <contact_backup>
      <last_name>Laurie Evans, MS</last_name>
      <phone>914-682-9100</phone>
      <phone_ext>1012570</phone_ext>
      <email>lad9011@med.cornell.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dimitris Kiosses, PhD</last_name>
      <phone>914-997-4381</phone>
      <email>dkiosses@med.cornell.edu</email>
    </contact>
    <contact_backup>
      <last_name>Laurie Evans, MS</last_name>
      <phone>914-682-9100</phone>
      <phone_ext>1012570</phone_ext>
      <email>lad9011@med.cornell.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</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>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be available as per NIH's data sharing policy.</ipd_description>
    <ipd_time_frame>Data will be available as per NIH's data sharing policy.</ipd_time_frame>
    <ipd_access_criteria>Access criteria is determined by NIH and can be requested by applying online.</ipd_access_criteria>
    <ipd_url>https://nda.nih.gov/</ipd_url>
  </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/NCT03043573
org study id: 1603017114
secondary id: 1R01AG050514
nct id: NCT03043573
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare
      Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs.
      Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive,
      affective, and functioning outcomes.
The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare
      Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs.
      Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive,
      affective and functioning outcomes. Psychotherapy, also known as talking therapy, is the use
      of psychological methods to help a person change and overcome problems in desired ways.
      PATH-MCI differs from standard of care psychotherapy by offering a combination of emotion
      regulation techniques with the provision of environmental adaptation tools (notes,
      checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing
      and available caregiver. Supportive Therapy incorporates standard of care approaches by using
      non-specific techniques to provide a supportive environment and help patients to express
      their feelings & focus on their strengths and abilities.

      The investigators plan to randomize 80 treatment subjects, older adults (40 at Cornell and 40
      at Johns Hopkins) with MCI-depression. 80 study partners may also be potentially recruited.
      Both sites have shown feasibility of recruitment, randomization, retention, and assessment
      procedures for patients with MCI. Cornell has shown evidence of administration of PATH in
      this population. Certified mental health clinicians in PATH-MCI and ST-CI will administer 15
      in-office sessions in six months.

      The investigators propose to compare the effects of 15 sessions (12 weekly in first 12 weeks
      and 3 monthly booster sessions afterwards) of PATH-MCI vs. ST-CI in 80 older adults
      (treatment subjects) with MCI-depression. Research assistants, unaware of study hypotheses
      and participant randomization status, will perform research assessments at baseline and at 6
      (no cognitive measures), 12, 24, 36 (no cognitive measures) and 52 weeks after randomization.

      There will also be optional blood draws at study entry, 12, and 52 weeks. The purpose of the
      blood draws is to better understand whether response to psychotherapy treatment is affected
      by genes, by inflammation, or by the possible memory factor called BDNF (brain-derived
      neurotrophic factor). Also, all therapy sessions will be audiotaped (if the patient consents)
      and Dr. Shermer (a clinician outside of the Weill Cornell Institute of Geriatric Psychiatry)
      will evaluate randomly selected sessions and rate the therapists' adherence and competence
      based on the PATH-MCI and ST Adherence Scales

      The study partner will provide information about the treatment subject and participate in
      treatment if agreed by the treatment subject. To explore the effects of PATH-MCI on the study
      partner, the investigators will collect the following data from the study partner:
      demographic, burden (Short Zarit Burden interview), and treatment satisfaction (Client
      Satisfaction Questionnaire).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in Global Cognition assessed by RBANS
time frame: Baseline, 12, 24, and 52 Weeks
description: Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS)
measure: Change in disability function assessed with WHODAS-II
time frame: Baseline, 6, 12, 24, 36, and 52 Weeks
description: Disability function, as measured by the World Health Organization Disability Assessment Schedule-II (WHODAS-II) Total score
measure: Change in Depression assessed by MADRS
time frame: Baseline, 6, 12, 24, 36, and 52 Weeks
description: Depression assessed by Montgomery Asberg Depression Rating Scale (MADRS) Total Score
measure: Change in Episodic Memory assessed by subscale of RBANS
time frame: Baseline, 12, 24, and 52 Weeks
description: Delayed Recall subscale of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
measure: Change in Executive Function assessed by Trail Making Test
time frame: Baseline, 12, 24, and 52 Weeks
description: Trail Making Test
measure: Change in Stress Reduction assessed by Perceived Stress Scale
time frame: Baseline, 6, 12, 24, 36, and 52 Weeks
description: Perceived Stress Scale
arm group label: PATH-MCI
arm group type: Experimental
description: Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.
arm group label: Supportive Therapy
arm group type: Active Comparator
description: Supportive Therapy focuses on: 1. Facilitating expression of affect; 2. Conveying to the patient that he or she is understood; 3. Offering empathy; and 4. Highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.
intervention type: Behavioral
intervention name: PATH-MCI
description: Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.
arm group label: PATH-MCI
intervention type: Behavioral
intervention name: Supportive Therapy
description: ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.
arm group label: Supportive Therapy
other name: ST
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
last name: Dimitris Kiosses, PhD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: Dimitris Kiosses, PhD
phone: 9149974381
email: dkiosses@med.cornell.edu
last name: Laurie Evans, MS
phone: 9146829100
phone ext: 1012570
email: lad9011@med.cornell.edu
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Cognitive Dysfunction
sharing ipd: Yes
ipd description: Data will be available as per NIH's data sharing policy.
ipd time frame: Data will be available as per NIH's data sharing policy.
ipd access criteria: Access criteria is determined by NIH and can be requested by applying online.
ipd url: https://nda.nih.gov/