<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/NCT01708200</url>
  </required_header>
  <id_info>
    <org_study_id>R.P. #12-3749</org_study_id>
    <secondary_id>SJHH</secondary_id>
    <nct_id>NCT01708200</nct_id>
  </id_info>
  <brief_title>A Comparison of the Effectiveness of Two Types of Memory Training Programs in People With a Diagnosis of Mental Illness.</brief_title>
  <official_title>A Comparison of the Effectiveness of Two Types of Cognitive Training Interventions Administered to Individuals With a Diagnosis of a Mental Health Condition.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Joseph's Healthcare Hamilton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Joseph's Healthcare Hamilton</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the effectiveness of a psychoeducational memory program versus a&#xD;
      computerized memory program in individuals with mental illness. Although improvements are&#xD;
      expected with both form of interventions, we do not know which will provide maximal benefit&#xD;
      in this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the current study is to compare two memory strategies, a top-down (i.e.,&#xD;
      educational and interventional)protocol vs. a bottom-up (computerized)protocol, in a&#xD;
      population of individuals diagnosed with mental illness. Performance on ecologically&#xD;
      validated memory tasks will be measured before and after each intervention protocol.&#xD;
      Improvements are expected following each protocol. However, there is no evidence available to&#xD;
      support added benefits from one protocol over another. As such, the current study will&#xD;
      endeavour to contrast the two intervention types (top-down vs. bottom-up) to determine which,&#xD;
      if any, provides maximal benefit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Declarative Memory Measure - Hopkins Verbal Learning Test</measure>
    <time_frame>Participants will be asked to complete this measure prior to the start of the intervention and again at the completion of the intervention (i.e., interval of 5 weeks between pre and post measurements).</time_frame>
    <description>Individuals participating in either protocol (i.e., top-down or bottom-up) will complete the memory measure before the commencement of the treatment and again at the end of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mood Measure - Depression Anxiety Stress Scale (Lovibond &amp; Lovibond, 1993)</measure>
    <time_frame>Participants will be asked to complete this measure prior to the start of the intervention and again at the completion of the intervention (i.e., interval of 5 weeks between pre and post measurements).</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Functional - Multifactorial Metamemory Questionnaire (Troyer &amp; Rich, 2011)</measure>
    <time_frame>Participants will be asked to complete this measure prior to the start of the intervention and again at the completion of the intervention (i.e., interval of 5 weeks between pre and post measurements).</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Memory Impairment</condition>
  <arm_group>
    <arm_group_label>Memory Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two types of memory protocols (psychoeducational vs computerized) will be compared in a population of individuals with mental illness.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Memory Intervention</intervention_name>
    <description>A comparison of two type of memory intervention protocols; a psychoeducational/intervention protocol versus a computerized memory protocol in a population of individuals with mental illness.</description>
    <arm_group_label>Memory Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Memory impairment equivalent to 1.5 std. dev. below average for age&#xD;
&#xD;
          -  Speak and read English fluently&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Older than 65 years of age&#xD;
&#xD;
          -  Significant visual impairment (e.g., cataracts, macular degeneration)&#xD;
&#xD;
          -  Motor impairment (e.g., hemiplegia on dominant side)&#xD;
&#xD;
          -  Diagnosis of Dementia&#xD;
&#xD;
          -  Alcohol and/or substance abuse (in past 3 months)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruno J Losier, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Joseph's Healthcare Hamilton</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bruno J Losier, Ph.D.</last_name>
    <phone>(905) 522-1155</phone>
    <phone_ext>35592</phone_ext>
    <email>losierb@stjoes.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michele Bridge</last_name>
    <phone>(905) 522-1155</phone>
    <phone_ext>36371</phone_ext>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. Joseph's Healthcare Hamilton</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3K7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <investigator>
      <last_name>Bruno J Losier, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 15, 2012</last_update_submitted>
  <last_update_submitted_qc>October 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Joseph's Healthcare Hamilton</investigator_affiliation>
    <investigator_full_name>Bruno Losier</investigator_full_name>
    <investigator_title>Clinical Neuropsychologist</investigator_title>
  </responsible_party>
  <keyword>Memory</keyword>
  <keyword>Intervention</keyword>
  <keyword>Computerized</keyword>
  <keyword>Psychoeducational</keyword>
  <keyword>Mental Illness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</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/NCT01708200
org study id: R.P. #12-3749
secondary id: SJHH
nct id: NCT01708200
lead sponsor: 
has dmc: No
This study will compare the effectiveness of a psychoeducational memory program versus a
      computerized memory program in individuals with mental illness. Although improvements are
      expected with both form of interventions, we do not know which will provide maximal benefit
      in this population.
The aim of the current study is to compare two memory strategies, a top-down (i.e.,
      educational and interventional)protocol vs. a bottom-up (computerized)protocol, in a
      population of individuals diagnosed with mental illness. Performance on ecologically
      validated memory tasks will be measured before and after each intervention protocol.
      Improvements are expected following each protocol. However, there is no evidence available to
      support added benefits from one protocol over another. As such, the current study will
      endeavour to contrast the two intervention types (top-down vs. bottom-up) to determine which,
      if any, provides maximal benefit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Declarative Memory Measure - Hopkins Verbal Learning Test
time frame: Participants will be asked to complete this measure prior to the start of the intervention and again at the completion of the intervention (i.e., interval of 5 weeks between pre and post measurements).
description: Individuals participating in either protocol (i.e., top-down or bottom-up) will complete the memory measure before the commencement of the treatment and again at the end of treatment.
measure: Mood Measure - Depression Anxiety Stress Scale (Lovibond & Lovibond, 1993)
time frame: Participants will be asked to complete this measure prior to the start of the intervention and again at the completion of the intervention (i.e., interval of 5 weeks between pre and post measurements).
measure: Functional - Multifactorial Metamemory Questionnaire (Troyer & Rich, 2011)
time frame: Participants will be asked to complete this measure prior to the start of the intervention and again at the completion of the intervention (i.e., interval of 5 weeks between pre and post measurements).
arm group label: Memory Intervention
arm group type: Experimental
description: Two types of memory protocols (psychoeducational vs computerized) will be compared in a population of individuals with mental illness.
intervention type: Other
intervention name: Memory Intervention
description: A comparison of two type of memory intervention protocols; a psychoeducational/intervention protocol versus a computerized memory protocol in a population of individuals with mental illness.
arm group label: Memory Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bruno J Losier, Ph.D.
role: Principal Investigator
affiliation: St. Joseph's Healthcare Hamilton
last name: Bruno J Losier, Ph.D.
phone: (905) 522-1155
phone ext: 35592
email: losierb@stjoes.ca
last name: Michele Bridge
phone: (905) 522-1155
phone ext: 36371
facility: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Joseph's Healthcare Hamilton
investigator full name: Bruno Losier
investigator title: Clinical Neuropsychologist
mesh term: Mental Disorders