<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/NCT04503798</url>
  </required_header>
  <id_info>
    <org_study_id>#08-53</org_study_id>
    <nct_id>NCT04503798</nct_id>
  </id_info>
  <brief_title>Online Cognitive Rehabilitation of Executive Dysfunction in Nonamnestic MCI</brief_title>
  <official_title>Rehabilitation of Executive Dysfunction in Nonamnestic MCI Using Online Goal Management Training®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baycrest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre for Aging and Brain Health Innovation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baycrest</source>
  <oversight_info>
    <has_dmc>No</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>
      Nonamnestic mild cognitive impairment (naMCI) is a prodromal state characterized by deficits&#xD;
      in executive functioning, a collection of higher-order abilities involved in organization,&#xD;
      planning, inhibition, and complex reasoning. Research shows that individuals with naMCI have&#xD;
      an increased risk of developing non-Alzheimer's dementia such as frontotemporal dementia and&#xD;
      dementia with Lewy bodies, which pose substantial personal and societal costs. Accordingly,&#xD;
      interventions that can successfully slow down or reverse the course of naMCI are needed.&#xD;
&#xD;
      Goal Management Training (GMT) is a cognitive rehabilitation platform that has been studied&#xD;
      extensively, applied clinically, and manualized into kits for clinicians (Levine et al.,&#xD;
      2000; Levine et al., 2007; Levine et al., 2011; Stamenova &amp; Levine, 2019). The purpose of GMT&#xD;
      is to train individuals to periodically &quot;STOP&quot; what they are doing, attend to task goals,&#xD;
      evaluate their performance, and monitor or check outcomes as they proceed. Recently, an&#xD;
      online version of GMT has been developed and validated in order to circumvent barriers to&#xD;
      attending in-person sessions.&#xD;
&#xD;
      The purpose of the current study is to determine if the online version of GMT is effective at&#xD;
      improving self-reported executive dysfunction in individuals diagnosed with naMCI against a&#xD;
      control group that is receiving treatment-as-usual from their care provider. It is&#xD;
      hypothesized that, compared to the control group, individuals receiving GMT will report a&#xD;
      decrease in executive function deficits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 20, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2021</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>Participants are screened, undergo a battery of tests at pre-test, and then are randomly assigned to one of two conditions: online GMT intervention or treatment-as-usual control group. After the intervention, the participants take the same test battery and complete it once more at 6 week follow-up.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The study personnel who conduct screening and send pre/post-test surveys to participants are all blinded.&#xD;
Randomizer is blinded to all participant pre-test outcomes. Care providers know what their participants are doing, but not aware of the full study design, including details of the other conditions or outcome test characteristics.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in dysexecutive functioning - participants' report</measure>
    <time_frame>Pre-intervention; Immediately post-intervention; 6 weeks post-intervention</time_frame>
    <description>Dysexecutive Functioning Index (DEX; Burgess et al., 1996) questionnaire measures self-reported deficits in executive functions, and is composed of one scale with scores ranging from 0-80, where higher scores indicate greater executive deficit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cognitive failures</measure>
    <time_frame>Pre-intervention; Immediately post-intervention; 6 weeks post-intervention</time_frame>
    <description>Cognitive Failures Questionnaire (CFQ; Broadbent et al., 1992) measures self-reported failures in perception, memory, and motor function. It contains a single scale with scores ranging from 0-100, where higher scores indicate greater degree of impairment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in dysexecutive functioning - carers' report</measure>
    <time_frame>Pre-intervention; Immediately post-intervention; 6 weeks post-intervention</time_frame>
    <description>Dysexecutive Functioning Index (DEX; Burgess et al., 1996) questionnaire completed by participants carers'.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Cambridge Brain Sciences online cognitive assessment</measure>
    <time_frame>Pre-intervention; Immediately post-intervention; 6 weeks post-intervention</time_frame>
    <description>Battery of online tasks that assess aspects of memory and reasoning (Hampshire et al., 2012).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in associative memory</measure>
    <time_frame>Pre-intervention; Immediately post-intervention; 6 weeks post-intervention</time_frame>
    <description>Face-name task associative memory score (Troyer et al., 2012).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Nonamnestic Mild Cognitive Impairment</condition>
  <condition>Cognitive Dysfunction</condition>
  <condition>Cognitive Disorder</condition>
  <condition>Neurocognitive Disorders</condition>
  <condition>Mental Disorder</condition>
  <condition>Cognitive Impairment, Mild</condition>
  <arm_group>
    <arm_group_label>Online Goal Management Training (GMT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The online version of GMT with a therapist on the back-end monitoring progress and giving feedback throughout the program. Online GMT takes 5-9 weeks (self-paced) to complete 9 modules involving instructional video with interactive content, practice of cognitive strategies through games, and between-module exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment-as-usual control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to this arm will receive no additional information or access to the intervention program. They will continue to receive treatment-as-usual from their care providers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online Goal Management Training</intervention_name>
    <description>Pre-recorded videos and games combine psycho-education, targeted skills training, and mindfulness practice to teach a system where participants can take control of their attention and cognitive faculties.</description>
    <arm_group_label>Online Goal Management Training (GMT)</arm_group_label>
    <other_name>GMT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of nonamnestic mild cognitive impairment&#xD;
&#xD;
          -  Available to participate in all testing and intervention sessions&#xD;
&#xD;
          -  Access to a computer&#xD;
&#xD;
          -  Computer familiarity&#xD;
&#xD;
          -  Normal or corrected-to-normal vision and hearing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of amnestic mild cognitive impairment or dementia&#xD;
&#xD;
          -  Moderate to severe affective impairment defined by score above cut-off for depression&#xD;
             on the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Levine, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baycrest Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brian Levine, PhD</last_name>
    <phone>416-785-2500</phone>
    <phone_ext>3593</phone_ext>
    <email>blevine@research.baycrest.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yushu Wang, MSc</last_name>
    <phone>416-785-2500</phone>
    <phone_ext>2914</phone_ext>
    <email>ywang@research.baycrest.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Baycrest Health Sciences</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6A2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brian Levine, PhD</last_name>
      <phone>416-785-2500</phone>
      <phone_ext>3593</phone_ext>
      <email>blevine@research.baycrest.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Burgess PW, Alderman N, Evans J, Emslie H, Wilson BA. The ecological validity of tests of executive function. J Int Neuropsychol Soc. 1998 Nov;4(6):547-58. doi: 10.1017/s1355617798466037.</citation>
    <PMID>10050359</PMID>
  </reference>
  <reference>
    <citation>Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.</citation>
    <PMID>7126941</PMID>
  </reference>
  <reference>
    <citation>Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.</citation>
    <PMID>11556941</PMID>
  </reference>
  <reference>
    <citation>Levine B, Robertson IH, Clare L, Carter G, Hong J, Wilson BA, Duncan J, Stuss DT. Rehabilitation of executive functioning: an experimental-clinical validation of goal management training. J Int Neuropsychol Soc. 2000 Mar;6(3):299-312. doi: 10.1017/s1355617700633052.</citation>
    <PMID>10824502</PMID>
  </reference>
  <reference>
    <citation>Levine B, Schweizer TA, O'Connor C, Turner G, Gillingham S, Stuss DT, Manly T, Robertson IH. Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci. 2011 Feb 17;5:9. doi: 10.3389/fnhum.2011.00009. eCollection 2011.</citation>
    <PMID>21369362</PMID>
  </reference>
  <reference>
    <citation>Levine B, Stuss DT, Winocur G, Binns MA, Fahy L, Mandic M, Bridges K, Robertson IH. Cognitive rehabilitation in the elderly: effects on strategic behavior in relation to goal management. J Int Neuropsychol Soc. 2007 Jan;13(1):143-52. doi: 10.1017/S1355617707070178.</citation>
    <PMID>17166313</PMID>
  </reference>
  <reference>
    <citation>Hampshire A, Highfield RR, Parkin BL, Owen AM. Fractionating human intelligence. Neuron. 2012 Dec 20;76(6):1225-37. doi: 10.1016/j.neuron.2012.06.022.</citation>
    <PMID>23259956</PMID>
  </reference>
  <reference>
    <citation>Troyer AK, Murphy KJ, Anderson ND, Craik FI, Moscovitch M, Maione A, Gao F. Associative recognition in mild cognitive impairment: relationship to hippocampal volume and apolipoprotein E. Neuropsychologia. 2012 Dec;50(14):3721-8. doi: 10.1016/j.neuropsychologia.2012.10.018. Epub 2012 Oct 24.</citation>
    <PMID>23103838</PMID>
  </reference>
  <reference>
    <citation>Stamenova V, Levine B. Effectiveness of goal management training(R) in improving executive functions: A meta-analysis. Neuropsychol Rehabil. 2019 Dec;29(10):1569-1599. doi: 10.1080/09602011.2018.1438294. Epub 2018 Mar 14.</citation>
    <PMID>29540124</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baycrest</investigator_affiliation>
    <investigator_full_name>Brian Levine</investigator_full_name>
    <investigator_title>Senior Scientist</investigator_title>
  </responsible_party>
  <keyword>nonamnestic MCI</keyword>
  <keyword>executive functions</keyword>
  <keyword>online cognitive intervention</keyword>
  <keyword>online cognitive rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Neurocognitive Disorders</mesh_term>
    <mesh_term>Cognition Disorders</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/NCT04503798
org study id: #08-53
nct id: NCT04503798
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nonamnestic mild cognitive impairment (naMCI) is a prodromal state characterized by deficits
      in executive functioning, a collection of higher-order abilities involved in organization,
      planning, inhibition, and complex reasoning. Research shows that individuals with naMCI have
      an increased risk of developing non-Alzheimer's dementia such as frontotemporal dementia and
      dementia with Lewy bodies, which pose substantial personal and societal costs. Accordingly,
      interventions that can successfully slow down or reverse the course of naMCI are needed.

      Goal Management Training (GMT) is a cognitive rehabilitation platform that has been studied
      extensively, applied clinically, and manualized into kits for clinicians (Levine et al.,
      2000; Levine et al., 2007; Levine et al., 2011; Stamenova & Levine, 2019). The purpose of GMT
      is to train individuals to periodically "STOP" what they are doing, attend to task goals,
      evaluate their performance, and monitor or check outcomes as they proceed. Recently, an
      online version of GMT has been developed and validated in order to circumvent barriers to
      attending in-person sessions.

      The purpose of the current study is to determine if the online version of GMT is effective at
      improving self-reported executive dysfunction in individuals diagnosed with naMCI against a
      control group that is receiving treatment-as-usual from their care provider. It is
      hypothesized that, compared to the control group, individuals receiving GMT will report a
      decrease in executive function deficits.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are screened, undergo a battery of tests at pre-test, and then are randomly assigned to one of two conditions: online GMT intervention or treatment-as-usual control group. After the intervention, the participants take the same test battery and complete it once more at 6 week follow-up.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The study personnel who conduct screening and send pre/post-test surveys to participants are all blinded.
Randomizer is blinded to all participant pre-test outcomes. Care providers know what their participants are doing, but not aware of the full study design, including details of the other conditions or outcome test characteristics.
measure: Change in dysexecutive functioning - participants' report
time frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
description: Dysexecutive Functioning Index (DEX; Burgess et al., 1996) questionnaire measures self-reported deficits in executive functions, and is composed of one scale with scores ranging from 0-80, where higher scores indicate greater executive deficit.
measure: Change in cognitive failures
time frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
description: Cognitive Failures Questionnaire (CFQ; Broadbent et al., 1992) measures self-reported failures in perception, memory, and motor function. It contains a single scale with scores ranging from 0-100, where higher scores indicate greater degree of impairment.
measure: Change in dysexecutive functioning - carers' report
time frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
description: Dysexecutive Functioning Index (DEX; Burgess et al., 1996) questionnaire completed by participants carers'.
measure: Change in Cambridge Brain Sciences online cognitive assessment
time frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
description: Battery of online tasks that assess aspects of memory and reasoning (Hampshire et al., 2012).
measure: Change in associative memory
time frame: Pre-intervention; Immediately post-intervention; 6 weeks post-intervention
description: Face-name task associative memory score (Troyer et al., 2012).
arm group label: Online Goal Management Training (GMT)
arm group type: Experimental
description: The online version of GMT with a therapist on the back-end monitoring progress and giving feedback throughout the program. Online GMT takes 5-9 weeks (self-paced) to complete 9 modules involving instructional video with interactive content, practice of cognitive strategies through games, and between-module exercises.
arm group label: Treatment-as-usual control group
arm group type: No Intervention
description: Participants randomized to this arm will receive no additional information or access to the intervention program. They will continue to receive treatment-as-usual from their care providers.
intervention type: Behavioral
intervention name: Online Goal Management Training
description: Pre-recorded videos and games combine psycho-education, targeted skills training, and mindfulness practice to teach a system where participants can take control of their attention and cognitive faculties.
arm group label: Online Goal Management Training (GMT)
other name: GMT
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Levine, PhD
role: Principal Investigator
affiliation: Baycrest Health Sciences
last name: Brian Levine, PhD
phone: 416-785-2500
phone ext: 3593
email: blevine@research.baycrest.org
last name: Yushu Wang, MSc
phone: 416-785-2500
phone ext: 2914
email: ywang@research.baycrest.org
facility: 
status: Recruiting
contact: 
country: Canada
citation: Burgess PW, Alderman N, Evans J, Emslie H, Wilson BA. The ecological validity of tests of executive function. J Int Neuropsychol Soc. 1998 Nov;4(6):547-58. doi: 10.1017/s1355617798466037.
PMID: 10050359
citation: Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.
PMID: 7126941
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PMID: 11556941
citation: Levine B, Robertson IH, Clare L, Carter G, Hong J, Wilson BA, Duncan J, Stuss DT. Rehabilitation of executive functioning: an experimental-clinical validation of goal management training. J Int Neuropsychol Soc. 2000 Mar;6(3):299-312. doi: 10.1017/s1355617700633052.
PMID: 10824502
citation: Levine B, Schweizer TA, O'Connor C, Turner G, Gillingham S, Stuss DT, Manly T, Robertson IH. Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci. 2011 Feb 17;5:9. doi: 10.3389/fnhum.2011.00009. eCollection 2011.
PMID: 21369362
citation: Levine B, Stuss DT, Winocur G, Binns MA, Fahy L, Mandic M, Bridges K, Robertson IH. Cognitive rehabilitation in the elderly: effects on strategic behavior in relation to goal management. J Int Neuropsychol Soc. 2007 Jan;13(1):143-52. doi: 10.1017/S1355617707070178.
PMID: 17166313
citation: Hampshire A, Highfield RR, Parkin BL, Owen AM. Fractionating human intelligence. Neuron. 2012 Dec 20;76(6):1225-37. doi: 10.1016/j.neuron.2012.06.022.
PMID: 23259956
citation: Troyer AK, Murphy KJ, Anderson ND, Craik FI, Moscovitch M, Maione A, Gao F. Associative recognition in mild cognitive impairment: relationship to hippocampal volume and apolipoprotein E. Neuropsychologia. 2012 Dec;50(14):3721-8. doi: 10.1016/j.neuropsychologia.2012.10.018. Epub 2012 Oct 24.
PMID: 23103838
citation: Stamenova V, Levine B. Effectiveness of goal management training(R) in improving executive functions: A meta-analysis. Neuropsychol Rehabil. 2019 Dec;29(10):1569-1599. doi: 10.1080/09602011.2018.1438294. Epub 2018 Mar 14.
PMID: 29540124
responsible party type: Principal Investigator
investigator affiliation: Baycrest
investigator full name: Brian Levine
investigator title: Senior Scientist
mesh term: Cognitive Dysfunction
mesh term: Mental Disorders
mesh term: Neurocognitive Disorders
mesh term: Cognition Disorders
sharing ipd: No