<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/NCT03005574</url>
  </required_header>
  <id_info>
    <org_study_id>4391</org_study_id>
    <nct_id>NCT03005574</nct_id>
  </id_info>
  <brief_title>Comparing Thinking Skills for Work (TSW)Home Practice Program With Traditional TSW Program</brief_title>
  <official_title>A Randomized Controlled Trial Comparing the Impact of Thinking Skills for Work (TSW)Tablet-based Home Practice Program on Cognitive Functioning and Work With the Traditional TSW Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University Charles River Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University Charles River Campus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if using a tablet computer, which is a very small,&#xD;
      easy-to-carry computer, to practice thinking exercises at home will help improve your&#xD;
      attention, memory, and problem solving abilities. All the participants will receive training&#xD;
      in the thinking skills for work program. But in order to determine the effect of tablet use&#xD;
      for home practice, half of the participants will be given a tablet to practice the thinking&#xD;
      exercises at home. All participants will be receiving vocational rehabilitation and have a&#xD;
      goal of getting a job.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Thinking Skills for Work (TSW) program has been shown to improve cognitive functioning&#xD;
      and work in multiple studies in a variety of vocational programs. TSW includes agency-based,&#xD;
      computer cognitive practice facilitated by a cognitive specialist, and teaching of&#xD;
      compensatory strategies to manage cognitive challenges, which are integrated with vocational&#xD;
      services. Supplementing agency-based practice with home practice on a tablet addresses the&#xD;
      need and desire for more cognitive practice, which is expected to further improve cognitive&#xD;
      and work outcomes.&#xD;
&#xD;
      This randomized controlled trial will evaluate the impact of supplementing the traditional&#xD;
      TSW cognitive practice with home based practice of cognitive exercises using a tablet.. Fifty&#xD;
      clients enrolled in vocational services at Brooklyn Community Services will be recruited and&#xD;
      randomized either to TSW-Home Practice (N=25) or traditional TSW (N=25).&#xD;
&#xD;
      All the participants will be assessed at baseline, 6 months and 12 months on cognitive&#xD;
      functioning and symptoms; work activity will be tracked for 12 months; program satisfaction&#xD;
      will be assessed at 6 and 12 months. The study will establish the efficacy of using home&#xD;
      practice on a tablet to increase the number of computer cognitive practice exercises&#xD;
      completed by clients.&#xD;
&#xD;
      Study hypotheses: 1) Individuals assigned to TSW HP will complete more cognitive practice&#xD;
      sessions using COGPACK software than those assigned to traditional TSW; 2) Individuals who&#xD;
      are exposed to TSW HP (i.e., complete 6 or more cognitive practice sessions) will complete&#xD;
      more practice sessions than those who are exposed to traditional TSW; 3) Individuals assigned&#xD;
      to TSW - HP will show greater improvements in cognitive functioning at post treatment and&#xD;
      follow up than those assigned to traditional TSW; 4) Individuals assigned to TSW - HP will&#xD;
      show greater improvements in work related outcomes (number of job interviews, % obtaining&#xD;
      competitive work, weeks worked, wages earned) at post-treatment and follow up than those&#xD;
      assigned to traditional TSW.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Measure of Change in Neurocognitive Functioning</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>Neurocognitive tests for primary outcome variables are from (MATRICS) Consensus Cognitive Battery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <condition>Bipolar Disorder</condition>
  <condition>Major Depression</condition>
  <arm_group>
    <arm_group_label>TSW-HP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TSW-HP Intervention implemented by a cognitive specialist over a 6-month treatment period which includes 24 hours (1 hour per week) of facilitated cognitive exercise sessions, which will be supplemented by approximately 24 hours of home practice sessions on a tablet computer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TSW-T</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants assigned to traditional TSW will receive the usual TSW program, which includes a one hour cognitive exercise practice session per week at Brooklyn Community Services (BCS) for 6 months. This group will not receive home based cognitive practice exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TSW-HP</intervention_name>
    <description>TSW-HP involves home practice of cognitive exercises along with the training sessions facilitated by the cognitive specialist at the agency.</description>
    <arm_group_label>TSW-HP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TSW-T</intervention_name>
    <description>Participants assigned to traditional TSW will receive the usual TSW program which includes a one hour session per week at BCS for 6 months. This group will not receive home based cognitive practice exercises</description>
    <arm_group_label>TSW-T</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        age 18 years or older; severe mental illness based on New York State Office of Mental&#xD;
        Health criteria; not competitively employed but want to work; enrolled in vocational&#xD;
        rehabilitation at Brooklyn Community Services; fluent in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        prior receipt of more than 3 sessions of Thinking Skills for Work (TSW) Cognitive&#xD;
        Remediation; medical disorder with known effects on cognitive functioning; inability to&#xD;
        give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan R McGurk, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Susan R McGurk, PhD</last_name>
    <phone>617- 353-3549</phone>
    <email>mcgurk@bu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brooklyn Community Services</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11236</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jodi Querbach</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University Charles River Campus</investigator_affiliation>
    <investigator_full_name>Susan Mcgurk</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Severe Mental Illness</keyword>
  <keyword>Cognitive Remediation</keyword>
  <keyword>Employment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar Disorder</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/NCT03005574
org study id: 4391
nct id: NCT03005574
lead sponsor: 
has dmc: No
The purpose of this study is to determine if using a tablet computer, which is a very small,
      easy-to-carry computer, to practice thinking exercises at home will help improve your
      attention, memory, and problem solving abilities. All the participants will receive training
      in the thinking skills for work program. But in order to determine the effect of tablet use
      for home practice, half of the participants will be given a tablet to practice the thinking
      exercises at home. All participants will be receiving vocational rehabilitation and have a
      goal of getting a job.
The Thinking Skills for Work (TSW) program has been shown to improve cognitive functioning
      and work in multiple studies in a variety of vocational programs. TSW includes agency-based,
      computer cognitive practice facilitated by a cognitive specialist, and teaching of
      compensatory strategies to manage cognitive challenges, which are integrated with vocational
      services. Supplementing agency-based practice with home practice on a tablet addresses the
      need and desire for more cognitive practice, which is expected to further improve cognitive
      and work outcomes.

      This randomized controlled trial will evaluate the impact of supplementing the traditional
      TSW cognitive practice with home based practice of cognitive exercises using a tablet.. Fifty
      clients enrolled in vocational services at Brooklyn Community Services will be recruited and
      randomized either to TSW-Home Practice (N=25) or traditional TSW (N=25).

      All the participants will be assessed at baseline, 6 months and 12 months on cognitive
      functioning and symptoms; work activity will be tracked for 12 months; program satisfaction
      will be assessed at 6 and 12 months. The study will establish the efficacy of using home
      practice on a tablet to increase the number of computer cognitive practice exercises
      completed by clients.

      Study hypotheses: 1) Individuals assigned to TSW HP will complete more cognitive practice
      sessions using COGPACK software than those assigned to traditional TSW; 2) Individuals who
      are exposed to TSW HP (i.e., complete 6 or more cognitive practice sessions) will complete
      more practice sessions than those who are exposed to traditional TSW; 3) Individuals assigned
      to TSW - HP will show greater improvements in cognitive functioning at post treatment and
      follow up than those assigned to traditional TSW; 4) Individuals assigned to TSW - HP will
      show greater improvements in work related outcomes (number of job interviews, % obtaining
      competitive work, weeks worked, wages earned) at post-treatment and follow up than those
      assigned to traditional TSW.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite Measure of Change in Neurocognitive Functioning
time frame: 6 months and 12 months
description: Neurocognitive tests for primary outcome variables are from (MATRICS) Consensus Cognitive Battery
arm group label: TSW-HP
arm group type: Experimental
description: TSW-HP Intervention implemented by a cognitive specialist over a 6-month treatment period which includes 24 hours (1 hour per week) of facilitated cognitive exercise sessions, which will be supplemented by approximately 24 hours of home practice sessions on a tablet computer.
arm group label: TSW-T
arm group type: Active Comparator
description: Participants assigned to traditional TSW will receive the usual TSW program, which includes a one hour cognitive exercise practice session per week at Brooklyn Community Services (BCS) for 6 months. This group will not receive home based cognitive practice exercises.
intervention type: Behavioral
intervention name: TSW-HP
description: TSW-HP involves home practice of cognitive exercises along with the training sessions facilitated by the cognitive specialist at the agency.
arm group label: TSW-HP
intervention type: Behavioral
intervention name: TSW-T
description: Participants assigned to traditional TSW will receive the usual TSW program which includes a one hour session per week at BCS for 6 months. This group will not receive home based cognitive practice exercises
arm group label: TSW-T
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan R McGurk, PhD
role: Principal Investigator
affiliation: Boston University
last name: Susan R McGurk, PhD
phone: 617- 353-3549
email: mcgurk@bu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University Charles River Campus
investigator full name: Susan Mcgurk
investigator title: Associate Professor
mesh term: Schizophrenia
mesh term: Bipolar Disorder
mesh term: Psychotic Disorders
sharing ipd: No