<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/NCT03000699</url>
  </required_header>
  <id_info>
    <org_study_id>077/2016</org_study_id>
    <nct_id>NCT03000699</nct_id>
  </id_info>
  <brief_title>Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction</brief_title>
  <official_title>Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Foundation for Suicide Prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre for Addiction and Mental Health</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to determine whether computer bias modification for&#xD;
      interpretation bias (CBM-I) is effective in the reduction of suicidal ideation in substance&#xD;
      use disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eighty-eight adult inpatients completing residential treatment in the Addictions Services at&#xD;
      the Centre for Addiction and Mental Health (CAMH) will be randomized to receive CBM-I daily&#xD;
      for one week, adjunct to the residential psychosocial treatment or to an assessment-only&#xD;
      control condition. Participants will complete clinical measures consisting of interviews and&#xD;
      questionnaires measuring suicidal ideation, hopelessness, depression, negative affect, and&#xD;
      interpretation biases before, during and after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Columbia-Suicide Severity Rating Scale, Screen Version (C-SSRS)</measure>
    <time_frame>Seven days</time_frame>
    <description>This scale quantifies the severity of suicidal ideation and behaviour.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Beck Hopelessness Scale (BHS)</measure>
    <time_frame>Seven days</time_frame>
    <description>This questionnaire assesses thoughts and emotions associated with the future.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory II (BDI-II)</measure>
    <time_frame>Seven days</time_frame>
    <description>This questionnaire assesses severity of depressive symptoms and cognitions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Affect Schedule (PANAS)</measure>
    <time_frame>Seven days</time_frame>
    <description>This questionnaire assesses current positive and negative mood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scrambled Sentences Tests</measure>
    <time_frame>Seven days</time_frame>
    <description>This computer test will be used as an implicit measure of negative interpretation bias.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Substance Dependence</condition>
  <arm_group>
    <arm_group_label>Cognitive Bias Modification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>64 training paragraphs, approximately 10-20 seconds each, digitally recorded and presented stereophonically through headphones, delivered over the course of one week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assessment-Only Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No training will be provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Bias Modification</intervention_name>
    <description>Training paragraphs describe scenarios designed to be ambiguous at the outset and to resolve in a positive direction, with the intention of establishing a learning contingency between the ambiguity at the beginning of the scenario and the positive resolution that becomes clear towards the end of the statement.</description>
    <arm_group_label>Cognitive Bias Modification</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Exhibit moderate suicide risk or greater&#xD;
&#xD;
          -  Be enrolled in the Addictions Services inpatient program&#xD;
&#xD;
          -  Fluent in reading English&#xD;
&#xD;
          -  Capacity to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A lifetime diagnosis of a psychotic or bipolar disorder&#xD;
&#xD;
          -  Significant neurological disorder or psychical illness likely to interfere with&#xD;
             participation&#xD;
&#xD;
          -  Psychotropic medication changes within the past two weeks&#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>Lena C Quilty, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Addiction and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 1R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.camh.ca/research</url>
    <description>Information about research at the Centre for Addiction and Mental Health</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>Lena Quilty</investigator_full_name>
    <investigator_title>Independent Scientist</investigator_title>
  </responsible_party>
  <keyword>cognitive bias modification</keyword>
  <keyword>interpretation bias</keyword>
  <keyword>suicidal ideation</keyword>
  <keyword>depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related 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/NCT03000699
org study id: 077/2016
nct id: NCT03000699
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether computer bias modification for
      interpretation bias (CBM-I) is effective in the reduction of suicidal ideation in substance
      use disorders.
Eighty-eight adult inpatients completing residential treatment in the Addictions Services at
      the Centre for Addiction and Mental Health (CAMH) will be randomized to receive CBM-I daily
      for one week, adjunct to the residential psychosocial treatment or to an assessment-only
      control condition. Participants will complete clinical measures consisting of interviews and
      questionnaires measuring suicidal ideation, hopelessness, depression, negative affect, and
      interpretation biases before, during and after treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Columbia-Suicide Severity Rating Scale, Screen Version (C-SSRS)
time frame: Seven days
description: This scale quantifies the severity of suicidal ideation and behaviour.
measure: Beck Hopelessness Scale (BHS)
time frame: Seven days
description: This questionnaire assesses thoughts and emotions associated with the future.
measure: Beck Depression Inventory II (BDI-II)
time frame: Seven days
description: This questionnaire assesses severity of depressive symptoms and cognitions.
measure: Positive and Negative Affect Schedule (PANAS)
time frame: Seven days
description: This questionnaire assesses current positive and negative mood
measure: Scrambled Sentences Tests
time frame: Seven days
description: This computer test will be used as an implicit measure of negative interpretation bias.
arm group label: Cognitive Bias Modification
arm group type: Experimental
description: 64 training paragraphs, approximately 10-20 seconds each, digitally recorded and presented stereophonically through headphones, delivered over the course of one week.
arm group label: Assessment-Only Control
arm group type: No Intervention
description: No training will be provided.
intervention type: Behavioral
intervention name: Cognitive Bias Modification
description: Training paragraphs describe scenarios designed to be ambiguous at the outset and to resolve in a positive direction, with the intention of establishing a learning contingency between the ambiguity at the beginning of the scenario and the positive resolution that becomes clear towards the end of the statement.
arm group label: Cognitive Bias Modification
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lena C Quilty, PhD
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
facility: 
country: Canada
url: http://www.camh.ca/research
description: Information about research at the Centre for Addiction and Mental Health
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: Lena Quilty
investigator title: Independent Scientist
mesh term: Substance-Related Disorders
sharing ipd: No