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/NCT06022107</url>
    </required_header>
    <id_info>
      <org_study_id>2000035434</org_study_id>
      <nct_id>NCT06022107</nct_id>
    </id_info>
    <brief_title>Social Support Intervention for Addiction Recovery</brief_title>
    <acronym>LDART</acronym>
    <official_title>Piloting a Novel Social Support Intervention for Addiction Recovery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Society of Addiction Psychology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Yale University</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>
        The purpose of this research study is to determine whether using a web-based intervention is&#xD;
        feasible, acceptable, and helpful for people who engage in hazardous alcohol use and want to&#xD;
        cut down or quit.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This pilot study will determine the feasibility and acceptability of a novel online social&#xD;
        support intervention (Let's Do Addiction Recovery Together!, abbreviated as LDART) that uses&#xD;
        pre-recorded videos created by members of recovery support services to help individuals in&#xD;
        early recovery from hazardous alcohol use sustain motivation during recovery and introduce&#xD;
        them to freely available recovery support services in the community. The investigators will&#xD;
        recruit participants to use the web-based intervention daily for a month; they will also fill&#xD;
        in questionnaires about their substance use and engagement with recovery support services at&#xD;
        the beginning and end of the study to determine preliminary efficacy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment feasibility</measure>
      <time_frame>Baseline</time_frame>
      <description>Feasibility of recruitment is measured as the number of adults who consent to study participation divided by the number of months the trial recruits for.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention feasibility</measure>
      <time_frame>One-month post-intervention (Day 56)</time_frame>
      <description>Retention rate is calculated as the number of participants who complete the study divided by the number of participants who consented to participating in the study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention acceptability (engagement with intervention)</measure>
      <time_frame>Duration of intervention (Days 1-28)</time_frame>
      <description>Acceptability is calculated as the number of nights participants login to LDART within the 28-day window.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention acceptability (subjective experience)</measure>
      <time_frame>Post-intervention (Day 28)</time_frame>
      <description>Acceptability is measured with a 9-item self-report acceptability assessment questionnaire. This comprises questions regarding the motivational and supportive properties of the content, perceptions on the frequency of engaging with the intervention, and whether they enjoyed using the intervention. Each question is rated on a 5-point Likert scale, where higher values indicate greater acceptability. There will also be two open-ended questions for participants to indicate what they liked and did not like about the intervention and ways to improve it.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Percent Drinking Days</measure>
      <time_frame>Day 0, 28, and 56</time_frame>
      <description>Timeline Follow Back is a validated, self-reported instrument that provides specific dates for alcohol use in the past 28 days, and the number of standard drinks consumed on each drinking day. Percent Drinking Days is calculated as the number of days in the 28-day window in which one or more standard drinks is consumed for two consecutive windows.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Percent Heavy Drinking Days</measure>
      <time_frame>Day 0, 28, and 56</time_frame>
      <description>Percent Heavy Drinking Days is calculated from the Timeline Follow Back instrument as the number of days in the 28-day window in which four/five or more standard drinks is consumed for women/men for two consecutive windows.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Hours Spent Engaging with Recovery Support Services</measure>
      <time_frame>Day 0, 28, and 56</time_frame>
      <description>The Timeline Follow Back instrument will be used to quantify number of hours spent engaging in recovery support services (e.g., being at a recovery community center, attending a support group meeting) each day in the past 28-day time window for two consecutive windows.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Quality of Life</measure>
      <time_frame>Day 0, 28, and 56</time_frame>
      <description>World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) is a 26-item questionnaire with four domains (score range in parentheses): physical health (7-35), psychological health (6-30), social relationships (3-15), and environment (8-40). Each question is rated on a five-point Likert scale, where higher values indicate higher quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Recovery Capital</measure>
      <time_frame>Day 0, 28, and 56</time_frame>
      <description>Brief Assessment of Recovery Capital (BARC) is a 10-item self-report measure of recovery capital with ten domains (substance use and sobriety, global psychological health, global physical health, citizenship and community involvement, social support, meaningful activities, housing and safety, risk-taking, coping and life functioning, recovery experience). Each item is rated in binary, so domain scores range from 0-5, and total score ranges from 0-10, where higher values indicate higher recovery capital.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Alcohol; Harmful Use</condition>
    <condition>Alcohol</condition>
    <arm_group>
      <arm_group_label>LDART</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be asked to log onto the LDART website each night for a month.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>LDART</intervention_name>
      <description>LDART is a newly developed web-based social support intervention that can be accessed by smartphone or computer. Each night, the participant sets a recovery goal for the next day (e.g., drink less than usual, go to a support group meeting). The next night, they log on to LDART to indicate whether they reached their goal for the day. Depending on their response, they will be shown either a celebratory or encouraging message from someone in the addiction recovery community, along with specific information on that person's recovery organization.</description>
      <arm_group_label>LDART</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  Is fluent in English and has a 6th grade reading level or higher&#xD;
  &#xD;
            -  Alcohol Use Disorders Identification Test (AUDIT) score of ≥8&#xD;
  &#xD;
            -  Has had at least one heavy drinking day in the past month&#xD;
  &#xD;
            -  Has some desire to cut down or quit their alcohol use&#xD;
  &#xD;
            -  Has a smartphone or computer with access to internet&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has vulnerable population status (e.g., pregnant people, prisoners)&#xD;
  &#xD;
            -  Is at the time of study participation receiving in-patient psychiatric treatment&#xD;
               involving hospitalization&#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>Marc N Potenza, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Li Yan McCurdy, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Li Yan McCurdy, PhD</last_name>
      <phone>2036518748</phone>
      <email>liyan.mccurdy@yale.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>1 Church St</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06510</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Li Yan McCurdy, PhD</last_name>
        <phone>203-651-8748</phone>
        <email>liyan.mccurdy@yale.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 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>Behavior, Addictive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06022107
  org study id: 2000035434
  nct id: NCT06022107
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this research study is to determine whether using a web-based intervention is
        feasible, acceptable, and helpful for people who engage in hazardous alcohol use and want to
        cut down or quit.
  This pilot study will determine the feasibility and acceptability of a novel online social
        support intervention (Let's Do Addiction Recovery Together!, abbreviated as LDART) that uses
        pre-recorded videos created by members of recovery support services to help individuals in
        early recovery from hazardous alcohol use sustain motivation during recovery and introduce
        them to freely available recovery support services in the community. The investigators will
        recruit participants to use the web-based intervention daily for a month; they will also fill
        in questionnaires about their substance use and engagement with recovery support services at
        the beginning and end of the study to determine preliminary efficacy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Recruitment feasibility
  time frame: Baseline
  description: Feasibility of recruitment is measured as the number of adults who consent to study participation divided by the number of months the trial recruits for.
  measure: Retention feasibility
  time frame: One-month post-intervention (Day 56)
  description: Retention rate is calculated as the number of participants who complete the study divided by the number of participants who consented to participating in the study.
  measure: Intervention acceptability (engagement with intervention)
  time frame: Duration of intervention (Days 1-28)
  description: Acceptability is calculated as the number of nights participants login to LDART within the 28-day window.
  measure: Intervention acceptability (subjective experience)
  time frame: Post-intervention (Day 28)
  description: Acceptability is measured with a 9-item self-report acceptability assessment questionnaire. This comprises questions regarding the motivational and supportive properties of the content, perceptions on the frequency of engaging with the intervention, and whether they enjoyed using the intervention. Each question is rated on a 5-point Likert scale, where higher values indicate greater acceptability. There will also be two open-ended questions for participants to indicate what they liked and did not like about the intervention and ways to improve it.
  measure: Change from Baseline in Percent Drinking Days
  time frame: Day 0, 28, and 56
  description: Timeline Follow Back is a validated, self-reported instrument that provides specific dates for alcohol use in the past 28 days, and the number of standard drinks consumed on each drinking day. Percent Drinking Days is calculated as the number of days in the 28-day window in which one or more standard drinks is consumed for two consecutive windows.
  measure: Change from Baseline in Percent Heavy Drinking Days
  time frame: Day 0, 28, and 56
  description: Percent Heavy Drinking Days is calculated from the Timeline Follow Back instrument as the number of days in the 28-day window in which four/five or more standard drinks is consumed for women/men for two consecutive windows.
  measure: Change from Baseline in Hours Spent Engaging with Recovery Support Services
  time frame: Day 0, 28, and 56
  description: The Timeline Follow Back instrument will be used to quantify number of hours spent engaging in recovery support services (e.g., being at a recovery community center, attending a support group meeting) each day in the past 28-day time window for two consecutive windows.
  measure: Change from Baseline in Quality of Life
  time frame: Day 0, 28, and 56
  description: World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) is a 26-item questionnaire with four domains (score range in parentheses): physical health (7-35), psychological health (6-30), social relationships (3-15), and environment (8-40). Each question is rated on a five-point Likert scale, where higher values indicate higher quality of life.
  measure: Change from Baseline in Recovery Capital
  time frame: Day 0, 28, and 56
  description: Brief Assessment of Recovery Capital (BARC) is a 10-item self-report measure of recovery capital with ten domains (substance use and sobriety, global psychological health, global physical health, citizenship and community involvement, social support, meaningful activities, housing and safety, risk-taking, coping and life functioning, recovery experience). Each item is rated in binary, so domain scores range from 0-5, and total score ranges from 0-10, where higher values indicate higher recovery capital.
  arm group label: LDART
  arm group type: Experimental
  description: Participants will be asked to log onto the LDART website each night for a month.
  intervention type: Behavioral
  intervention name: LDART
  description: LDART is a newly developed web-based social support intervention that can be accessed by smartphone or computer. Each night, the participant sets a recovery goal for the next day (e.g., drink less than usual, go to a support group meeting). The next night, they log on to LDART to indicate whether they reached their goal for the day. Depending on their response, they will be shown either a celebratory or encouraging message from someone in the addiction recovery community, along with specific information on that person's recovery organization.
  arm group label: LDART
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marc N Potenza, MD, PhD
  role: Principal Investigator
  affiliation: Yale University
  last name: Li Yan McCurdy, PhD
  role: Principal Investigator
  affiliation: Yale University
  last name: Li Yan McCurdy, PhD
  phone: 2036518748
  email: liyan.mccurdy@yale.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Behavior, Addictive
  sharing ipd: No