<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/NCT03024203</url>
  </required_header>
  <id_info>
    <org_study_id>PSYC-173-16</org_study_id>
    <nct_id>NCT03024203</nct_id>
  </id_info>
  <brief_title>A Comparison of Cognitive Training Approaches in Psychotic Disorders</brief_title>
  <official_title>A Comparison of Cognitive Training Approaches in Psychotic Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen's University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for&#xD;
      individuals with psychosis, however, there is no gold standard method of cognitive&#xD;
      remediation available. Cognitive training refers to the training component of CR in which&#xD;
      people practice computerized exercises that train specific cognitive abilities. There is no&#xD;
      agreed upon approach within the field as to the type of training that is most effective with&#xD;
      some studies, training higher level cognitive abilities, some training perceptual abilities,&#xD;
      and others training general cognitive skills. This study will directly compare two competing&#xD;
      methods of cognitive training on measures of neurophysiology, neurocognition, functional&#xD;
      competence, and real-world functional performance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline</measure>
    <time_frame>Post-treatment (within 2 weeks following the end of treatment)</time_frame>
    <description>Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline</measure>
    <time_frame>Post-treatment (within 2 weeks following the end of treatment)</time_frame>
    <description>The MCCB is the gold standard cognitive assessment for schizophrenia research</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Neurophysiology - EEG from Baseline</measure>
    <time_frame>Post-treatment (within 2 weeks following the end of treatment)</time_frame>
    <description>Alpha and Theta band synchronization, p300, mismatch negativity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline</measure>
    <time_frame>Post-treatment (within 2 weeks following the end of treatment)</time_frame>
    <description>Performance based measure of real life functional skills using role-play</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline</measure>
    <time_frame>Follow-Up (3 months after the end of treatment)</time_frame>
    <description>Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline</measure>
    <time_frame>Follow-Up (3 months after the end of treatment)</time_frame>
    <description>The MCCB is the gold standard cognitive assessment for schizophrenia research</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Neurophysiology - EEG from Baseline</measure>
    <time_frame>Follow-Up (3 months after the end of treatment)</time_frame>
    <description>Alpha and Theta band synchronization, p300, mismatch negativity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline</measure>
    <time_frame>Follow-Up (3 months after the end of treatment)</time_frame>
    <description>Performance based measure of real life functional skills using role-play</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Psychotic Disorders</condition>
  <arm_group>
    <arm_group_label>Executive Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Executive Training (ET) involves training on computerized cognitive exercises that have graded increases in difficulty so that the participant is always challenged. A therapist will be in the room with participants to address any difficulties with the program and facilitate generation of strategies. ET will be delivered in both individual and group settings.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Perceptual Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Perceptual Training (PT) involves training on computerized cognitive exercises that have graded increases in difficulty so that the participant is always challenged. A therapist will be in the room with participants to address any difficulties with the program and facilitate generation of strategies. PT will be delivered in both individual and group settings.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Remediation - Executive Training</intervention_name>
    <description>Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as memory, and problem solving ability.</description>
    <arm_group_label>Executive Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Remediation - Perceptual Training</intervention_name>
    <description>Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as attention, and processing speed.</description>
    <arm_group_label>Perceptual Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  psychotic disorder&#xD;
&#xD;
          -  No previous cognitive remediation in past 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Brain injury&#xD;
&#xD;
          -  Substance abuse&#xD;
&#xD;
          -  Neurocognitive disorder&#xD;
&#xD;
          -  Developmental Disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Queen's University</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 5P6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>November 12, 2018</last_update_submitted>
  <last_update_submitted_qc>November 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University</investigator_affiliation>
    <investigator_full_name>Dr. Christopher Bowie</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic 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/NCT03024203
org study id: PSYC-173-16
nct id: NCT03024203
lead sponsor: 
has dmc: No
Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for
      individuals with psychosis, however, there is no gold standard method of cognitive
      remediation available. Cognitive training refers to the training component of CR in which
      people practice computerized exercises that train specific cognitive abilities. There is no
      agreed upon approach within the field as to the type of training that is most effective with
      some studies, training higher level cognitive abilities, some training perceptual abilities,
      and others training general cognitive skills. This study will directly compare two competing
      methods of cognitive training on measures of neurophysiology, neurocognition, functional
      competence, and real-world functional performance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline
time frame: Post-treatment (within 2 weeks following the end of treatment)
description: Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks
measure: Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline
time frame: Post-treatment (within 2 weeks following the end of treatment)
description: The MCCB is the gold standard cognitive assessment for schizophrenia research
measure: Change in Neurophysiology - EEG from Baseline
time frame: Post-treatment (within 2 weeks following the end of treatment)
description: Alpha and Theta band synchronization, p300, mismatch negativity
measure: Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline
time frame: Post-treatment (within 2 weeks following the end of treatment)
description: Performance based measure of real life functional skills using role-play
measure: Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline
time frame: Follow-Up (3 months after the end of treatment)
description: Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks
measure: Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline
time frame: Follow-Up (3 months after the end of treatment)
description: The MCCB is the gold standard cognitive assessment for schizophrenia research
measure: Change in Neurophysiology - EEG from Baseline
time frame: Follow-Up (3 months after the end of treatment)
description: Alpha and Theta band synchronization, p300, mismatch negativity
measure: Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline
time frame: Follow-Up (3 months after the end of treatment)
description: Performance based measure of real life functional skills using role-play
arm group label: Executive Training
arm group type: Experimental
description: Executive Training (ET) involves training on computerized cognitive exercises that have graded increases in difficulty so that the participant is always challenged. A therapist will be in the room with participants to address any difficulties with the program and facilitate generation of strategies. ET will be delivered in both individual and group settings.
arm group label: Perceptual Training
arm group type: Experimental
description: Perceptual Training (PT) involves training on computerized cognitive exercises that have graded increases in difficulty so that the participant is always challenged. A therapist will be in the room with participants to address any difficulties with the program and facilitate generation of strategies. PT will be delivered in both individual and group settings.
intervention type: Behavioral
intervention name: Cognitive Remediation - Executive Training
description: Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as memory, and problem solving ability.
arm group label: Executive Training
intervention type: Behavioral
intervention name: Cognitive Remediation - Perceptual Training
description: Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as attention, and processing speed.
arm group label: Perceptual Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Queen's University
investigator full name: Dr. Christopher Bowie
investigator title: Principal Investigator
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: No