<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/NCT03814122</url>
  </required_header>
  <id_info>
    <org_study_id>H2017:214</org_study_id>
    <nct_id>NCT03814122</nct_id>
  </id_info>
  <brief_title>Action-based Cognitive Remediation for First Episode Psychosis</brief_title>
  <official_title>Examining the Effectiveness of Action-based Cognitive Remediation for First Episode Psychosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manitoba</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>
      Cognitive impairments are a core and enduring feature of first-episode psychosis and&#xD;
      schizophrenia, and are associated with significant functional impairment. Cognitive&#xD;
      remediation (CR) is a behavioural intervention that has been found to have a small to&#xD;
      moderate effect on cognition in individuals with schizophrenia, and recent studies suggests&#xD;
      that it leads to improved cognition in persons with first-episode psychosis. Results from a&#xD;
      CR feasibility project that was conducted through the Winnipeg Regional Health Authority's&#xD;
      Early Psychosis Prevention and Intervention Service (EPPIS) showed promising findings.&#xD;
      Specifically, large effect sizes were found in the areas of verbal learning and self-esteem.&#xD;
      Moreover, the intervention was found to be acceptable to the participants. However, the&#xD;
      findings are limited by the sample size and lack of control group.&#xD;
&#xD;
      In this proposed study, the investigators seek to expand the scientific support for treating&#xD;
      neurocognitive impairments in order to increase functional productivity associated with&#xD;
      first-episode psychosis. A novel group CR program, action-based cognitive remediation (ABCR),&#xD;
      has been developed by Dr. C. Bowie (co-investigator) to promote the generalization of&#xD;
      cognitive skills to real-world activities. ABCR has been found to improve both cognition and&#xD;
      functional competence in persons with schizophrenia. The primary outcome measure will examine&#xD;
      whether ABCR results in improved executive functioning in persons with first-episode&#xD;
      psychosis compared to psychiatric rehabilitation alone. Secondary outcome measures (e.g.,&#xD;
      memory, processing speed, self-esteem, emotional functioning, adaptive functioning) will also&#xD;
      be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will be a two-group randomized control cross-over trial. Participants will&#xD;
      be recruited from EPPIS and will be randomly assigned to receive ABCR or treatment-as-usual&#xD;
      (TAU) for a period of 8 weeks. After this time, the TAU group will receive ABCR. TAU will be&#xD;
      the psychiatric rehabilitation programming offered to all patients enrolled with EPPIS. ABCR&#xD;
      will consist of two, 2-hour groups/week, for a period of 8 weeks. Each group session will&#xD;
      consist of: (1) computerized cognitive training using Scientific Brain Training Pro (an&#xD;
      online program used in previous CR and ABCR research), (2) strategic monitoring (i.e.,&#xD;
      increasing awareness of cognitive strategies used and learning to switch strategies as&#xD;
      needed), (3) role-plays and simulations of real world tasks to facilitate the transfer of&#xD;
      skills to functioning, and (4) goal setting and cognitive approach planning. ABCR builds on&#xD;
      procedural learning skills with explicit work-related role-plays to facilitate the immediate&#xD;
      and salient abstraction of drill and practice remediation techniques. The activities are work&#xD;
      skills that were developed by Dr. Bowie (co-investigator) in collaboration with community&#xD;
      vocational rehabilitation partners. The props match those used in work settings and were&#xD;
      designed on a miniature scale and include a cash register, filing system, conveyer belt,&#xD;
      cleaning closet, garden nursery, and secretarial station. The activities in ABCR capitalize&#xD;
      on procedural learning skills through role-plays and props that simulate a work environment.&#xD;
      In ABCR, the important aspects of drill and practice, strategic monitoring to enhance&#xD;
      flexible problem solving approaches, and bridging are maintained. The role-plays immediately&#xD;
      follow the computerized drill and practice exercise and therapists facilitate group&#xD;
      discussions of how the cognitive skills and flexibility in thinking from drill and practice&#xD;
      can be effective while directly engaged in an everyday work environment. Thus, the bridging&#xD;
      used in ABCR is a tangible, procedural, and realistic. This approach to bridging&#xD;
      differentiates the treatment from standard CR, where the discussion-based approach is limited&#xD;
      by the auditory learning, memory, and abstraction deficits typically observed in psychosis.&#xD;
      ABCR group sessions will be facilitated by the Primary Investigator and trained bachelor's or&#xD;
      master's level research assistants/psychology residents who will be trained and supervised by&#xD;
      the Primary Investigator. Participants will also be encouraged to complete computerized&#xD;
      cognitive training using the online program, Scientific Brain Training Pro as supplemental&#xD;
      homework exercises outside of the scheduled treatment group (20 minutes/day). Due to the&#xD;
      online nature of this program, participants can access this program either at their personal&#xD;
      homes or at EPPIS.&#xD;
&#xD;
      Evaluations of each participant's cognitive functioning, self-esteem, psychotic symptoms, and&#xD;
      functional skills will be completed at baseline and post-treatment (approximately 8 weeks&#xD;
      later). The TAU group will then participate in ABCR and all participants will be re-evaluated&#xD;
      following completion of the second intervention (at approximately 16 weeks post-baseline).&#xD;
      Testing will be administered by trained bachelor's or master's level research assistants who&#xD;
      are blind to study hypothesis or group assignment. These assistants will be trained and&#xD;
      supervised by the Primary Investigator. Test batteries will be presented in counterbalanced&#xD;
      order and, when possible, alternate forms will be used to reduce the likelihood of practice&#xD;
      effects.Using a repeated measures analysis of covariance (ANCOVA), the treatment and control&#xD;
      group's post-intervention data will be compared while controlling for pre-treatment scores.&#xD;
      For all analyses, p &lt; .05 will be used as the statistical threshold for significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2019</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 14, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>The proposed study will be a two-group randomized control cross-over trial. Participants will be randomly assigned to receive ABCR or treatment-as-usual (TAU) for a period of 8 weeks. After this time, the TAU group will receive ABCR. Evaluations of the participant's cognitive functioning, self-esteem, psychotic symptoms, and functional skills will be completed at baseline, post-treatment (approximately 8 weeks), and 16 weeks later.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Pre- and post- assessments will be administered by someone blind to group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Executive Functioning; Wisconsin Card Sorting Test (Heaton and PAR Staff, 2005).</measure>
    <time_frame>Baseline, after approximately 8 weeks and 16 weeks</time_frame>
    <description>Commonly used neuropsychological computerized test to assess the ability to form abstract concepts, to shift and maintain set, and to utilize feedback. Total number of categories completed and perseverative errors (reported as t-score with range &lt;20 to &gt;80) will be reported. Higher values indicate better outcome. More information can be found at: http://www4.parinc.com/Products/Product.aspx?ProductID=WCST</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive Functioning; Screen for Cognitive Impairment in Psychiatry (Purdon, 2005).</measure>
    <time_frame>Baseline, after approximately 8 weeks and 16 weeks</time_frame>
    <description>Scale for screening cognitive deficits in persons with schizophrenia and psychiatry, including verbal learning and memory, auditory working memory, verbal fluency and visuomotor tracking. Total score reported as a z-score (range of -3 to +3). Higher values indicate better performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychotic Symptoms; Brief Psychotic Rating Scale (Overall &amp; Gorham, 1962).</measure>
    <time_frame>Baseline, after approximately 8 weeks and 16 weeks</time_frame>
    <description>A 24-item measure commonly used in research and clinical settings that is designed to quantify the severity of positive and negative symptoms of psychosis. Scale ranges from 24-168. Higher values indicate greater number and severity of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Skills; Canadian Objective Life Skills (COALS) (McDermid Vaz &amp; Heinrichs)</measure>
    <time_frame>Baseline, after approximately 8 weeks and 16 weeks</time_frame>
    <description>Participants are examined with a series of role-playing tasks for their comprehension and planning of recreational activities, financial skills in handling money and writing checks, use of a telephone for instrumental communication, and ability to use information from bus schedules and maps to use public transportation effectively. Total score ranges from 0-60. Higher value indicates better performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visual Memory; Brief visuospatial memory test-revised (Benedict, 1997).</measure>
    <time_frame>Baseline, after approximately 8 weeks and 16 weeks</time_frame>
    <description>Commonly-used neuropsychological measure of visual learning and memory that uses a multiple-figural test to assess immediate memory, delayed memory and recognition abilities. Recall scores are reported as t-scores (range: &lt;20-80) and higher values indicate better performance. Please note that a copy of the test protocol cannot be provided due to copyright protection, but more information can be found at: http://www4.parinc.com/Products/Product.aspx?ProductID=BVMT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Esteem; Rosenberg Self-Esteem Scale (Rosenberg, 1965).</measure>
    <time_frame>Baseline, after approximately 8 weeks and 16 weeks</time_frame>
    <description>A 10-item measure that is commonly used to measure self-esteem. Respondents are asked to read a list of statements dealing with general feelings about themselves and rate each one on a four-point scale from SD =Strongly Disagree (score of 0) to SA =Strongly Agree (score of 3). Scores are summed to provide a total score for the measure. Total score ranges from 0-30, with higher values indicating higher self-esteem.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Disability Beliefs; World Health Organization Disability Assessment Schedule II (World Health Organization)</measure>
    <time_frame>Baseline, after approximately 8 weeks and 16 weeks</time_frame>
    <description>36-item self-administered measure that assesses disability in adults over 18 years. Total score ranges from 0-144 with higher scores indicating greater perceived disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Illness Beliefs; Personal Beliefs About Illness Questionnaire-Revised (Birchwood, Jackson, Brunet, Holden &amp; Barton, 2012).</measure>
    <time_frame>Baseline, after approximately 8 weeks and 16 weeks</time_frame>
    <description>20-item, self-report measure that assesses common psychological reactions related to loss, social marginalization, shame, entrapment, and control in persons with a first-episode psychosis. Total score ranges from 0-60. Higher scores indicate negative reactions to the diagnosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Competence; Perceived Competence for Learning Scale</measure>
    <time_frame>Baseline, after approximately 8 weeks and 16 weeks</time_frame>
    <description>4-item self-report measure assessing person's feeling of competence to master learning material. Total score ranges from 4-28. Higher scores indicate greater perceived competence.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Cognitive Impairment</condition>
  <condition>Psychosis</condition>
  <arm_group>
    <arm_group_label>ABCR Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group that is immediately administered action-based cognitive remediation intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group that is waitlisted (i.e., receives treatment-as-usual) and after approximately 8 weeks received action-based cognitive remediation intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Action-based cognitive remediation</intervention_name>
    <description>Action-Based Cognitive Remediation (ABCR) is a new program that was developed to address the challenges of transferring cognitive gains to improved quality of life and reduced disability. ABCR combines traditional cognitive training with an added behavioural component (e.g., role-plays, simulations of real world tasks) to foster learning through rehearsal and procedural memory which increases the likelihood of participants bridging cognitive strategies into real-world activities. ABCR also includes goal setting and behavioural activation procedures to stimulate transfer of in-session gains to everyday life changes.</description>
    <arm_group_label>ABCR Treatment Group</arm_group_label>
    <arm_group_label>Waitlist Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Waitlist Control Group</intervention_name>
    <description>Receive treatment-as-usual through regular early psychosis programming.</description>
    <arm_group_label>Waitlist Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Involved in the Winnipeg Regional Health Authority's Early Psychosis Prevention and&#xD;
             Intervention Service&#xD;
&#xD;
          -  Must be at least 18 years old&#xD;
&#xD;
          -  Be proficient in English&#xD;
&#xD;
          -  Have stable medication orders for 3 months&#xD;
&#xD;
          -  Have capacity to voluntarily consent to participate in the treatment study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Organic brain damage&#xD;
&#xD;
          -  Intellectual disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>37 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colleen Murphy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Crisis Response Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0Y1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</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>Psychotic Disorders</mesh_term>
    <mesh_term>Mental 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/NCT03814122
org study id: H2017:214
nct id: NCT03814122
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cognitive impairments are a core and enduring feature of first-episode psychosis and
      schizophrenia, and are associated with significant functional impairment. Cognitive
      remediation (CR) is a behavioural intervention that has been found to have a small to
      moderate effect on cognition in individuals with schizophrenia, and recent studies suggests
      that it leads to improved cognition in persons with first-episode psychosis. Results from a
      CR feasibility project that was conducted through the Winnipeg Regional Health Authority's
      Early Psychosis Prevention and Intervention Service (EPPIS) showed promising findings.
      Specifically, large effect sizes were found in the areas of verbal learning and self-esteem.
      Moreover, the intervention was found to be acceptable to the participants. However, the
      findings are limited by the sample size and lack of control group.

      In this proposed study, the investigators seek to expand the scientific support for treating
      neurocognitive impairments in order to increase functional productivity associated with
      first-episode psychosis. A novel group CR program, action-based cognitive remediation (ABCR),
      has been developed by Dr. C. Bowie (co-investigator) to promote the generalization of
      cognitive skills to real-world activities. ABCR has been found to improve both cognition and
      functional competence in persons with schizophrenia. The primary outcome measure will examine
      whether ABCR results in improved executive functioning in persons with first-episode
      psychosis compared to psychiatric rehabilitation alone. Secondary outcome measures (e.g.,
      memory, processing speed, self-esteem, emotional functioning, adaptive functioning) will also
      be analyzed.
The proposed study will be a two-group randomized control cross-over trial. Participants will
      be recruited from EPPIS and will be randomly assigned to receive ABCR or treatment-as-usual
      (TAU) for a period of 8 weeks. After this time, the TAU group will receive ABCR. TAU will be
      the psychiatric rehabilitation programming offered to all patients enrolled with EPPIS. ABCR
      will consist of two, 2-hour groups/week, for a period of 8 weeks. Each group session will
      consist of: (1) computerized cognitive training using Scientific Brain Training Pro (an
      online program used in previous CR and ABCR research), (2) strategic monitoring (i.e.,
      increasing awareness of cognitive strategies used and learning to switch strategies as
      needed), (3) role-plays and simulations of real world tasks to facilitate the transfer of
      skills to functioning, and (4) goal setting and cognitive approach planning. ABCR builds on
      procedural learning skills with explicit work-related role-plays to facilitate the immediate
      and salient abstraction of drill and practice remediation techniques. The activities are work
      skills that were developed by Dr. Bowie (co-investigator) in collaboration with community
      vocational rehabilitation partners. The props match those used in work settings and were
      designed on a miniature scale and include a cash register, filing system, conveyer belt,
      cleaning closet, garden nursery, and secretarial station. The activities in ABCR capitalize
      on procedural learning skills through role-plays and props that simulate a work environment.
      In ABCR, the important aspects of drill and practice, strategic monitoring to enhance
      flexible problem solving approaches, and bridging are maintained. The role-plays immediately
      follow the computerized drill and practice exercise and therapists facilitate group
      discussions of how the cognitive skills and flexibility in thinking from drill and practice
      can be effective while directly engaged in an everyday work environment. Thus, the bridging
      used in ABCR is a tangible, procedural, and realistic. This approach to bridging
      differentiates the treatment from standard CR, where the discussion-based approach is limited
      by the auditory learning, memory, and abstraction deficits typically observed in psychosis.
      ABCR group sessions will be facilitated by the Primary Investigator and trained bachelor's or
      master's level research assistants/psychology residents who will be trained and supervised by
      the Primary Investigator. Participants will also be encouraged to complete computerized
      cognitive training using the online program, Scientific Brain Training Pro as supplemental
      homework exercises outside of the scheduled treatment group (20 minutes/day). Due to the
      online nature of this program, participants can access this program either at their personal
      homes or at EPPIS.

      Evaluations of each participant's cognitive functioning, self-esteem, psychotic symptoms, and
      functional skills will be completed at baseline and post-treatment (approximately 8 weeks
      later). The TAU group will then participate in ABCR and all participants will be re-evaluated
      following completion of the second intervention (at approximately 16 weeks post-baseline).
      Testing will be administered by trained bachelor's or master's level research assistants who
      are blind to study hypothesis or group assignment. These assistants will be trained and
      supervised by the Primary Investigator. Test batteries will be presented in counterbalanced
      order and, when possible, alternate forms will be used to reduce the likelihood of practice
      effects.Using a repeated measures analysis of covariance (ANCOVA), the treatment and control
      group's post-intervention data will be compared while controlling for pre-treatment scores.
      For all analyses, p < .05 will be used as the statistical threshold for significance.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The proposed study will be a two-group randomized control cross-over trial. Participants will be randomly assigned to receive ABCR or treatment-as-usual (TAU) for a period of 8 weeks. After this time, the TAU group will receive ABCR. Evaluations of the participant's cognitive functioning, self-esteem, psychotic symptoms, and functional skills will be completed at baseline, post-treatment (approximately 8 weeks), and 16 weeks later.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Pre- and post- assessments will be administered by someone blind to group assignment.
measure: Change in Executive Functioning; Wisconsin Card Sorting Test (Heaton and PAR Staff, 2005).
time frame: Baseline, after approximately 8 weeks and 16 weeks
description: Commonly used neuropsychological computerized test to assess the ability to form abstract concepts, to shift and maintain set, and to utilize feedback. Total number of categories completed and perseverative errors (reported as t-score with range <20 to >80) will be reported. Higher values indicate better outcome. More information can be found at: http://www4.parinc.com/Products/Product.aspx?ProductID=WCST
measure: Change in Cognitive Functioning; Screen for Cognitive Impairment in Psychiatry (Purdon, 2005).
time frame: Baseline, after approximately 8 weeks and 16 weeks
description: Scale for screening cognitive deficits in persons with schizophrenia and psychiatry, including verbal learning and memory, auditory working memory, verbal fluency and visuomotor tracking. Total score reported as a z-score (range of -3 to +3). Higher values indicate better performance.
measure: Change in Psychotic Symptoms; Brief Psychotic Rating Scale (Overall & Gorham, 1962).
time frame: Baseline, after approximately 8 weeks and 16 weeks
description: A 24-item measure commonly used in research and clinical settings that is designed to quantify the severity of positive and negative symptoms of psychosis. Scale ranges from 24-168. Higher values indicate greater number and severity of symptoms.
measure: Change in Functional Skills; Canadian Objective Life Skills (COALS) (McDermid Vaz & Heinrichs)
time frame: Baseline, after approximately 8 weeks and 16 weeks
description: Participants are examined with a series of role-playing tasks for their comprehension and planning of recreational activities, financial skills in handling money and writing checks, use of a telephone for instrumental communication, and ability to use information from bus schedules and maps to use public transportation effectively. Total score ranges from 0-60. Higher value indicates better performance.
measure: Change in Visual Memory; Brief visuospatial memory test-revised (Benedict, 1997).
time frame: Baseline, after approximately 8 weeks and 16 weeks
description: Commonly-used neuropsychological measure of visual learning and memory that uses a multiple-figural test to assess immediate memory, delayed memory and recognition abilities. Recall scores are reported as t-scores (range: <20-80) and higher values indicate better performance. Please note that a copy of the test protocol cannot be provided due to copyright protection, but more information can be found at: http://www4.parinc.com/Products/Product.aspx?ProductID=BVMT.
measure: Change in Self-Esteem; Rosenberg Self-Esteem Scale (Rosenberg, 1965).
time frame: Baseline, after approximately 8 weeks and 16 weeks
description: A 10-item measure that is commonly used to measure self-esteem. Respondents are asked to read a list of statements dealing with general feelings about themselves and rate each one on a four-point scale from SD =Strongly Disagree (score of 0) to SA =Strongly Agree (score of 3). Scores are summed to provide a total score for the measure. Total score ranges from 0-30, with higher values indicating higher self-esteem.
measure: Change in Disability Beliefs; World Health Organization Disability Assessment Schedule II (World Health Organization)
time frame: Baseline, after approximately 8 weeks and 16 weeks
description: 36-item self-administered measure that assesses disability in adults over 18 years. Total score ranges from 0-144 with higher scores indicating greater perceived disability.
measure: Change in Illness Beliefs; Personal Beliefs About Illness Questionnaire-Revised (Birchwood, Jackson, Brunet, Holden & Barton, 2012).
time frame: Baseline, after approximately 8 weeks and 16 weeks
description: 20-item, self-report measure that assesses common psychological reactions related to loss, social marginalization, shame, entrapment, and control in persons with a first-episode psychosis. Total score ranges from 0-60. Higher scores indicate negative reactions to the diagnosis.
measure: Change in Perceived Competence; Perceived Competence for Learning Scale
time frame: Baseline, after approximately 8 weeks and 16 weeks
description: 4-item self-report measure assessing person's feeling of competence to master learning material. Total score ranges from 4-28. Higher scores indicate greater perceived competence.
arm group label: ABCR Treatment Group
arm group type: Experimental
description: Group that is immediately administered action-based cognitive remediation intervention.
arm group label: Waitlist Control Group
arm group type: Active Comparator
description: Group that is waitlisted (i.e., receives treatment-as-usual) and after approximately 8 weeks received action-based cognitive remediation intervention
intervention type: Behavioral
intervention name: Action-based cognitive remediation
description: Action-Based Cognitive Remediation (ABCR) is a new program that was developed to address the challenges of transferring cognitive gains to improved quality of life and reduced disability. ABCR combines traditional cognitive training with an added behavioural component (e.g., role-plays, simulations of real world tasks) to foster learning through rehearsal and procedural memory which increases the likelihood of participants bridging cognitive strategies into real-world activities. ABCR also includes goal setting and behavioural activation procedures to stimulate transfer of in-session gains to everyday life changes.
arm group label: ABCR Treatment Group
arm group label: Waitlist Control Group
intervention type: Other
intervention name: Waitlist Control Group
description: Receive treatment-as-usual through regular early psychosis programming.
arm group label: Waitlist Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 37 Years
healthy volunteers: No
last name: Colleen Murphy, PhD
role: Principal Investigator
affiliation: University of Manitoba
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Psychotic Disorders
mesh term: Mental Disorders
sharing ipd: No