xml: <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/NCT06011070</url>
    </required_header>
    <id_info>
      <org_study_id>HR-22/23-36398</org_study_id>
      <nct_id>NCT06011070</nct_id>
    </id_info>
    <brief_title>Brief Online Personalised Feedback Intervention for Gambling Harm</brief_title>
    <official_title>Pilot Randomised Trial of a Brief Online Personalised Feedback Intervention for the UK Context Designed to Prevent, Reduce, and Address Gambling Harm</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King's College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>King's College London</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>
        Purpose and significance A brief self-directed online personalised feedback intervention was&#xD;
        developed for the UK context designed to prevent, reduce, and address gambling harm. The&#xD;
        intervention, which also comes in a paper format, comprises of normative feedback and&#xD;
        personalised information on the risk of gambling above lower-risk gambling guidelines. The&#xD;
        content is based on recent work adapting the Canadian lower-risk gambling guidelines to the&#xD;
        UK context. The purpose of this exploratory research is to conduct the first randomised&#xD;
        controlled trial of this intervention. Further, given the increased prevalence of online&#xD;
        gambling, the project will target this at-risk population.&#xD;
  &#xD;
        Rationale This project will generate participant feedback on the intervention important to&#xD;
        improve its utility. The project will also produce publishable findings on the intervention's&#xD;
        efficacy. This evaluation provides a necessary first step towards the wide-spread&#xD;
        implementation of this free-of-charge intervention in the UK.&#xD;
  &#xD;
        Methodology First, using methods developed in our previous research, we will rapidly recruit&#xD;
        926 online gambling participants with moderate or problem gambling from an existing online&#xD;
        panel of UK residents. These participants will be randomised to receive the self-directed&#xD;
        online intervention or assigned to a no intervention control group. Participants will be&#xD;
        followed-up up at one- and three-months to provide detailed feedback on their impressions of&#xD;
        the intervention (and what further modifications are needed) and to assess the short-term&#xD;
        impact of the intervention on gambling frequency and harm.&#xD;
  &#xD;
        Potential implications of the proposed research The intervention can be accessed at any time&#xD;
        of the day and allow the delivery of help without requiring face-to-face contact. Online&#xD;
        interventions also have the potential to promote reductions in social inequalities through&#xD;
        reducing barriers to accessible care. At present, there appears to be no UK online at-risk&#xD;
        gambling intervention that is publicly available.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>number of days gambled in the last month</measure>
      <time_frame>1 and 3 months</time_frame>
      <description>The number of days the participants reports gambling in the past month</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">1586</enrollment>
    <condition>Problem Gambling</condition>
    <arm_group>
      <arm_group_label>Gambling Personalised Feedback</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in gambling</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention Control</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Gambling Personalised Feedback</intervention_name>
      <description>The intervention is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in gambling</description>
      <arm_group_label>Gambling Personalised Feedback</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Problem gambling severity index score of 3 or more&#xD;
  &#xD;
            -  Willingness to complete 1 and 3-month follow-up surveys&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            -  Do not live in the United Kingdom&#xD;
  &#xD;
            -  Incorrectly answer attention check question on baseline survey&#xD;
  &#xD;
            -  Do not endorse that they answered all questions truthfully on the baseline survey&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>King's College London</name>
        <address>
          <city>London</city>
          <zip>SE1 9NH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Gambling</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011070
  org study id: HR-22/23-36398
  nct id: NCT06011070
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Purpose and significance A brief self-directed online personalised feedback intervention was
        developed for the UK context designed to prevent, reduce, and address gambling harm. The
        intervention, which also comes in a paper format, comprises of normative feedback and
        personalised information on the risk of gambling above lower-risk gambling guidelines. The
        content is based on recent work adapting the Canadian lower-risk gambling guidelines to the
        UK context. The purpose of this exploratory research is to conduct the first randomised
        controlled trial of this intervention. Further, given the increased prevalence of online
        gambling, the project will target this at-risk population.
  
        Rationale This project will generate participant feedback on the intervention important to
        improve its utility. The project will also produce publishable findings on the intervention's
        efficacy. This evaluation provides a necessary first step towards the wide-spread
        implementation of this free-of-charge intervention in the UK.
  
        Methodology First, using methods developed in our previous research, we will rapidly recruit
        926 online gambling participants with moderate or problem gambling from an existing online
        panel of UK residents. These participants will be randomised to receive the self-directed
        online intervention or assigned to a no intervention control group. Participants will be
        followed-up up at one- and three-months to provide detailed feedback on their impressions of
        the intervention (and what further modifications are needed) and to assess the short-term
        impact of the intervention on gambling frequency and harm.
  
        Potential implications of the proposed research The intervention can be accessed at any time
        of the day and allow the delivery of help without requiring face-to-face contact. Online
        interventions also have the potential to promote reductions in social inequalities through
        reducing barriers to accessible care. At present, there appears to be no UK online at-risk
        gambling intervention that is publicly available.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: number of days gambled in the last month
  time frame: 1 and 3 months
  description: The number of days the participants reports gambling in the past month
  arm group label: Gambling Personalised Feedback
  arm group type: Experimental
  description: The intervention is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in gambling
  arm group label: Control
  arm group type: No Intervention
  description: No intervention Control
  intervention type: Behavioral
  intervention name: Gambling Personalised Feedback
  description: The intervention is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in gambling
  arm group label: Gambling Personalised Feedback
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Gambling
  sharing ipd: Yes