<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/NCT02977026</url>
  </required_header>
  <id_info>
    <org_study_id>107/2016</org_study_id>
    <nct_id>NCT02977026</nct_id>
  </id_info>
  <brief_title>Comparing the Efficacy of the Alcohol Help Centre and Check Your Drinking to a no Intervention Control Condition</brief_title>
  <official_title>Comparing the Efficacy of the Alcohol Help Centre and Check Your Drinking to a no Intervention Control Condition: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre for Addiction and Mental Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alcohol is one of the leading contributors to premature mortality and disability. Most people&#xD;
      with alcohol problems will never seek treatment. There is a need to develop alternate ways to&#xD;
      help problem drinkers outside of formal treatment settings.&#xD;
&#xD;
      One promising strategy is Internet-based interventions for problem drinkers. Our recently&#xD;
      completed RCT comparing a brief (Check Your Drinking; CYD) versus an extended (Alcohol Help&#xD;
      Centre; AHC) Internet intervention for problem drinkers found that, while there was a&#xD;
      reduction in drinking across time for both interventions, there was no significant (p &gt; .05)&#xD;
      difference in reductions in drinking between the two interventions. Based on these results,&#xD;
      it is not justifiable to say that either intervention 'worked' as there was no comparison&#xD;
      condition of participants who received no active intervention. The current trial proposes to&#xD;
      address this limitation by conducting an RCT comparing the CYD, AHC, and a no intervention&#xD;
      control condition.&#xD;
&#xD;
      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants&#xD;
      identified as problem drinkers based on an initial survey will be invited to complete another&#xD;
      survey in 6 months time. Those who are interested will be randomized to receive access to the&#xD;
      Check Your Drinking screener (CYD condition), Alcohol Help Centre (AHC condition) or a&#xD;
      feedback questionnaire (control condition). At six-months post-baseline, the MTurk portal&#xD;
      will be used to send invitation emails that contain a link to the follow-up survey. The&#xD;
      primary hypothesis to be tested is that participants receiving access to the AHC intervention&#xD;
      will report a greater reduction in AUDIT-C scores and in number of drinks in a typical week&#xD;
      than participants in the CYD intervention. Further, participants in the CYD condition will&#xD;
      report a greater level of reduction AUDIT-C scores and in number of drinks in a typical week&#xD;
      between the baseline survey and six-month follow-up as compared to participants in the no&#xD;
      intervention control condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of drinks in a typical week from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Sum of number of drinks consumed in a typical week</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">511</enrollment>
  <condition>Alcohol Consumption</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A questionnaire that asks individuals what components of an online intervention they might find useful.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Check Your Drinking (CYD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Internet based program of lower intensity as compared to the &quot;Alcohol Help Centre. It was designed to provide personalized normative feedback aimed at motivating reductions in drinking</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alcohol Help Centre (AHC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Internet based program of higher intensity as compared to the &quot;Check Your Drinking&quot; intervention. It was designed to assesses drinking patterns, increase self-awareness of individual triggers, and set and achieve goals regarding drinking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CYD</intervention_name>
    <arm_group_label>Check Your Drinking (CYD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AHC</intervention_name>
    <arm_group_label>Alcohol Help Centre (AHC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or over&#xD;
&#xD;
          -  A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)&#xD;
&#xD;
          -  Typically consumes 15 or more drinks per week,&#xD;
&#xD;
          -  Willingness to complete a 6-month follow-up survey&#xD;
&#xD;
        Exclusion Criteria:None&#xD;
&#xD;
        -&#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>John A Cunningham, 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>M5S 2S1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>August 10, 2017</last_update_submitted>
  <last_update_submitted_qc>August 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</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>John Cunningham</investigator_full_name>
    <investigator_title>Senior Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</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/NCT02977026
org study id: 107/2016
nct id: NCT02977026
lead sponsor: 
has dmc: No
Alcohol is one of the leading contributors to premature mortality and disability. Most people
      with alcohol problems will never seek treatment. There is a need to develop alternate ways to
      help problem drinkers outside of formal treatment settings.

      One promising strategy is Internet-based interventions for problem drinkers. Our recently
      completed RCT comparing a brief (Check Your Drinking; CYD) versus an extended (Alcohol Help
      Centre; AHC) Internet intervention for problem drinkers found that, while there was a
      reduction in drinking across time for both interventions, there was no significant (p > .05)
      difference in reductions in drinking between the two interventions. Based on these results,
      it is not justifiable to say that either intervention 'worked' as there was no comparison
      condition of participants who received no active intervention. The current trial proposes to
      address this limitation by conducting an RCT comparing the CYD, AHC, and a no intervention
      control condition.

      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants
      identified as problem drinkers based on an initial survey will be invited to complete another
      survey in 6 months time. Those who are interested will be randomized to receive access to the
      Check Your Drinking screener (CYD condition), Alcohol Help Centre (AHC condition) or a
      feedback questionnaire (control condition). At six-months post-baseline, the MTurk portal
      will be used to send invitation emails that contain a link to the follow-up survey. The
      primary hypothesis to be tested is that participants receiving access to the AHC intervention
      will report a greater reduction in AUDIT-C scores and in number of drinks in a typical week
      than participants in the CYD intervention. Further, participants in the CYD condition will
      report a greater level of reduction AUDIT-C scores and in number of drinks in a typical week
      between the baseline survey and six-month follow-up as compared to participants in the no
      intervention control condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Change in number of drinks in a typical week from baseline
time frame: 6 months
description: Sum of number of drinks consumed in a typical week
arm group label: Control
arm group type: No Intervention
description: A questionnaire that asks individuals what components of an online intervention they might find useful.
arm group label: Check Your Drinking (CYD)
arm group type: Experimental
description: Internet based program of lower intensity as compared to the "Alcohol Help Centre. It was designed to provide personalized normative feedback aimed at motivating reductions in drinking
arm group label: Alcohol Help Centre (AHC)
arm group type: Experimental
description: Internet based program of higher intensity as compared to the "Check Your Drinking" intervention. It was designed to assesses drinking patterns, increase self-awareness of individual triggers, and set and achieve goals regarding drinking.
intervention type: Behavioral
intervention name: CYD
arm group label: Check Your Drinking (CYD)
intervention type: Behavioral
intervention name: AHC
arm group label: Alcohol Help Centre (AHC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John A Cunningham, PhD
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: John Cunningham
investigator title: Senior Scientist
mesh term: Alcohol Drinking
sharing ipd: No