<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/NCT04505345</url>
  </required_header>
  <id_info>
    <org_study_id>SLB_AUD02</org_study_id>
    <nct_id>NCT04505345</nct_id>
  </id_info>
  <brief_title>Virtual Reality Cognitive Training in Alcohol Use Disorder</brief_title>
  <official_title>Virtual Reality Cognitive Training in Individuals With Alcohol Use Disorder Undergoing Residential Treatment: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Lusófona de Humanidades e Tecnologias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Casa de Saúde do Telhal - Instituto São João de Deus, Portugal.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Lusófona de Humanidades e Tecnologias</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>
      This study aims to test the feasibility of using exercises in virtual reality for cognitive&#xD;
      training of patients with alcohol use disorder undergoing residential treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alcohol use disorder has been associated with diverse physical and mental morbidities. Among&#xD;
      the main consequences of chronic and excessive alcohol use are cognitive and executive&#xD;
      deficits. Some of these deficits may be reversed, with improvements in specific cognitive and&#xD;
      executive domains, with behavioral approaches consisting in cognitive training. The advent of&#xD;
      computer-based interventions may leverage these improvements, but RCTs on the use of digital&#xD;
      interactive-based intervention are still scarce.&#xD;
&#xD;
      The aim consists in exploring whether a cognitive training approach using virtual reality&#xD;
      exercises based on activities of daily living is feasible for improving cognitive function in&#xD;
      patients with alcohol use disorder undergoing residential treatment.&#xD;
&#xD;
      The method consists in a two-arm randomized controlled trial with individuals recovering from&#xD;
      alcohol use disorder in a therapeutic community that will be assigned to an experimental and&#xD;
      a control group. The experimental group consists of virtual reality-based cognitive training&#xD;
      whereas the control group of treatment-as-usual. A comprehensive neuropsychological battery&#xD;
      of tests will be used consisting in tests for global cognition, executive functions, and&#xD;
      specific tests form memory, attention and cognitive flexibility. The AB design will involve a&#xD;
      baseline assessment before intervention and post-intervention assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 30, 2017</start_date>
  <completion_date type="Anticipated">July 30, 2024</completion_date>
  <primary_completion_date type="Actual">September 30, 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>
    <intervention_model_description>The individuals will be distributed by two groups: experimental and control. The experimental group consists of treatment with virtual reality cognitive training and the control group of treatment-as-usual.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Executive functions</measure>
    <time_frame>5 weeks</time_frame>
    <description>Executive functions are a set of higher order cognitive functions that control goal directed behavior. Executive functions in this study are assessed using the Frontal Assessment Battery that evaluates six constructs: conceptualization, mental flexibility, programming, sensitivity to interference, inhibitory control, and environmental autonomy. This study focuses on the total score that is calculated from sum of scores to each of the six dimensions of the test, in which higher scores describe better test performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive flexibility</measure>
    <time_frame>5 weeks</time_frame>
    <description>Cognitive flexibility describes the ability to switch between different tasks. Cognitive flexibility in this study is assessed using the Wisconsin Card Sorting Test that evaluates strategic planning, abstract thinking, and capacity for perseveration and the ability to use environmental feedback. This test in this study is scored on six performance parameters: Number of trials administered; number of total errors; number of perseverative errors; number of trials to complete first category; failure to maintain set; and number of conceptual level responses. Higher scores in these dimensions reflect poorer test performance, except for the number of conceptual level responses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global cognition</measure>
    <time_frame>5 weeks</time_frame>
    <description>Global cognition is assessed using the Montreal Cognitive Assessment that is a cognitive screening test that consists of 11 items assessing cognitive domains such as visuospatial orientation, naming, memory, attention, language, abstraction, evocation and orientation. This study focuses on the total score that is calculated from the sum of scores to each dimension of the test, in which higher scores reflect better test performance.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Cognitive Function</condition>
  <condition>Feasibility</condition>
  <arm_group>
    <arm_group_label>Virtual reality cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual reality cognitive training consists of a behavioral intervention of 10 sessions of training using virtual reality exercises depicting daily life activities from the Systemic Lisbon Battery aiming cognitive impairments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment-as-usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment-as-usual for alcohol use disorder (AUD) in our partner institution, a therapeutic community for rehabilitation of AUD, is conducted according to the Minnesota Model requiring alcohol abstinence.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive training using the Systemic Lisbon Battery</intervention_name>
    <description>The Systemic Lisbon Battery comprises exercises for cognitive rehabilitation developed to describe diverse activities of daily living.</description>
    <arm_group_label>Virtual reality cognitive training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment-as-usual</intervention_name>
    <description>Treatment as usual for alcohol use disorder from Casa de Saúde do Telhal is delivered according to the Minnesota Model.</description>
    <arm_group_label>Treatment-as-usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years old&#xD;
&#xD;
          -  Without history of psychiatric or neurological disorders&#xD;
&#xD;
          -  Attending the inpatient program for rehabilitation of alcohol use disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychosis episode during the intervention&#xD;
&#xD;
          -  Withdrawal from the inpatient program for rehabilitation of alcohol use disorder&#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>Pedro Gamito, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Lusófona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Casa de Saúde do Telhal</name>
      <address>
        <city>Sintra</city>
        <zip>2725-588</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</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>Alcoholism</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/NCT04505345
org study id: SLB_AUD02
nct id: NCT04505345
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to test the feasibility of using exercises in virtual reality for cognitive
      training of patients with alcohol use disorder undergoing residential treatment.
Alcohol use disorder has been associated with diverse physical and mental morbidities. Among
      the main consequences of chronic and excessive alcohol use are cognitive and executive
      deficits. Some of these deficits may be reversed, with improvements in specific cognitive and
      executive domains, with behavioral approaches consisting in cognitive training. The advent of
      computer-based interventions may leverage these improvements, but RCTs on the use of digital
      interactive-based intervention are still scarce.

      The aim consists in exploring whether a cognitive training approach using virtual reality
      exercises based on activities of daily living is feasible for improving cognitive function in
      patients with alcohol use disorder undergoing residential treatment.

      The method consists in a two-arm randomized controlled trial with individuals recovering from
      alcohol use disorder in a therapeutic community that will be assigned to an experimental and
      a control group. The experimental group consists of virtual reality-based cognitive training
      whereas the control group of treatment-as-usual. A comprehensive neuropsychological battery
      of tests will be used consisting in tests for global cognition, executive functions, and
      specific tests form memory, attention and cognitive flexibility. The AB design will involve a
      baseline assessment before intervention and post-intervention assessment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The individuals will be distributed by two groups: experimental and control. The experimental group consists of treatment with virtual reality cognitive training and the control group of treatment-as-usual.
primary purpose: Treatment
masking: None (Open Label)
measure: Executive functions
time frame: 5 weeks
description: Executive functions are a set of higher order cognitive functions that control goal directed behavior. Executive functions in this study are assessed using the Frontal Assessment Battery that evaluates six constructs: conceptualization, mental flexibility, programming, sensitivity to interference, inhibitory control, and environmental autonomy. This study focuses on the total score that is calculated from sum of scores to each of the six dimensions of the test, in which higher scores describe better test performance.
measure: Cognitive flexibility
time frame: 5 weeks
description: Cognitive flexibility describes the ability to switch between different tasks. Cognitive flexibility in this study is assessed using the Wisconsin Card Sorting Test that evaluates strategic planning, abstract thinking, and capacity for perseveration and the ability to use environmental feedback. This test in this study is scored on six performance parameters: Number of trials administered; number of total errors; number of perseverative errors; number of trials to complete first category; failure to maintain set; and number of conceptual level responses. Higher scores in these dimensions reflect poorer test performance, except for the number of conceptual level responses.
measure: Global cognition
time frame: 5 weeks
description: Global cognition is assessed using the Montreal Cognitive Assessment that is a cognitive screening test that consists of 11 items assessing cognitive domains such as visuospatial orientation, naming, memory, attention, language, abstraction, evocation and orientation. This study focuses on the total score that is calculated from the sum of scores to each dimension of the test, in which higher scores reflect better test performance.
arm group label: Virtual reality cognitive training
arm group type: Experimental
description: Virtual reality cognitive training consists of a behavioral intervention of 10 sessions of training using virtual reality exercises depicting daily life activities from the Systemic Lisbon Battery aiming cognitive impairments.
arm group label: Treatment-as-usual
arm group type: Other
description: Treatment-as-usual for alcohol use disorder (AUD) in our partner institution, a therapeutic community for rehabilitation of AUD, is conducted according to the Minnesota Model requiring alcohol abstinence.
intervention type: Behavioral
intervention name: Cognitive training using the Systemic Lisbon Battery
description: The Systemic Lisbon Battery comprises exercises for cognitive rehabilitation developed to describe diverse activities of daily living.
arm group label: Virtual reality cognitive training
intervention type: Behavioral
intervention name: Treatment-as-usual
description: Treatment as usual for alcohol use disorder from Casa de Saúde do Telhal is delivered according to the Minnesota Model.
arm group label: Treatment-as-usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pedro Gamito, PhD
role: Principal Investigator
affiliation: University Lusófona
facility: 
country: Portugal
responsible party type: Sponsor
mesh term: Alcoholism
sharing ipd: No