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/NCT05995886</url>
    </required_header>
    <id_info>
      <org_study_id>23-005038</org_study_id>
      <secondary_id>DA40316-08S2</secondary_id>
      <nct_id>NCT05995886</nct_id>
    </id_info>
    <brief_title>Using Facebook to Support Opioid Recovery Among American Indian Women</brief_title>
    <official_title>Facebook Intervention for Preventing Opioid Relapse Among American Indian Women: Wiidookaage'Win Pilot Preparatory Study (Aim 2)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Mayo Clinic</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 study is to find out whether a Facebook group will help Native women in&#xD;
        recovery from opioid use.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of Facebook Intervention</measure>
      <time_frame>3 months</time_frame>
      <description>The study team will measure the feasibility from the combined reports of recruitment, study retention, level of Facebook intervention uptake/engagement, and treatment satisfaction.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Timeline Follow-back Interview and UDS to measure Opioid Abstinence</measure>
      <time_frame>6 months</time_frame>
      <description>The study team will explore the preliminary differential impact of the intervention compared with the control condition on opioid abstinence and MOUD continuation. Opioid and other substance use will be assessed through monthly Timeline Follow-Back (TLFB) interviews (Sobell &amp; Sobell, 1992; Wray et al., 2016). At 1, 3, and 6-months, the study team will obtain a UDS that will be used along with the TLFB interviews to measure opioid abstinence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reporting MOUD continuation</measure>
      <time_frame>6 months</time_frame>
      <description>The study team will summarize MOUD continuation as the proportion of participants reporting current use at 6-month follow-up.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Perceived Stress Scale and Communal Mastery Scale</measure>
      <time_frame>3 months</time_frame>
      <description>The study team will explore the differential impact of the intervention compared with the control condition on constructs targeted by our intervention, specifically perceived stress and coping with stressful life circumstances from a more collectivist orientation, respectively.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Opioid Use Disorder</condition>
    <arm_group>
      <arm_group_label>Wiidookaage'win Facebook Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Wiidookaage'win Facebook Group is an online, asynchronous group intervention that will run for 3-months with approximately 30 days of content developed. It is private and hidden, meaning only those in the study will be able to see or find the group. It will be moderated by two women from the study team (one AIAN and one biracial). A back-up moderator will also have access to the group. Participants will be able to comment, react, view, and post in the intervention group, and are encouraged to interact with one another.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Online Resources Landing Page</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The Online Resources Landing Page was developed by the study team using https://carrd.co. It includes links to local programs in family services, substance use recovery, legal advocacy, etc. which already exist and may help support their recovery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Wiidookaage'win Facebook Group</intervention_name>
      <description>An online social media group program that incorporates social support, mindfulness-based, and cultural practices that may support OUD recovery.</description>
      <arm_group_label>Wiidookaage'win Facebook Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. AIAN person based on self-reported race/ethnicity&#xD;
  &#xD;
            2. Gender identity as a woman&#xD;
  &#xD;
            3. At least 18 years of age with no upper age limit&#xD;
  &#xD;
            4. Resides in Minnesota&#xD;
  &#xD;
            5. Meets criteria for OUD based on the DSM-5 Checklist (American Psychiatric Association,&#xD;
               2013)&#xD;
  &#xD;
            6. Self-reports at least one month of abstinence from opioid use based on TLFB interview&#xD;
               and negative urine opiate screen&#xD;
  &#xD;
            7. Current use of MOUD&#xD;
  &#xD;
            8. Is comfortable speaking and reading English&#xD;
  &#xD;
            9. Has an existing Facebook account or willing to set one up&#xD;
  &#xD;
           10. Is willing and able to participate in the Facebook intervention for 3 months&#xD;
  &#xD;
           11. Has access to broadband internet on a mobile phone/computer/tablet at any location&#xD;
  &#xD;
           12. Is willing and able to travel to a community clinic in Minneapolis, Minnesota for the&#xD;
               UDS&#xD;
  &#xD;
           13. Provides written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Self-reports current suicidality based on the Concise Heath Risk Tracking scale&#xD;
  &#xD;
            2. Participated in prior study phases (Aim 1 formative work) of NIDA CTN-0123&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Participants may be cisgender or transgender women. They may also identify as Two Spirit and include &quot;woman&quot; as part of their gender identity.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christi A Patten, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Antonia M Young, BA</last_name>
      <phone>1-833-880-2600</phone>
      <email>wiidookaagewin@mayo.edu</email>
    </overall_contact>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Christi Patten</investigator_full_name>
      <investigator_title>Professor of Psychology</investigator_title>
    </responsible_party>
    <keyword>American Indian or Alaska Native</keyword>
    <keyword>Internet-based Intervention</keyword>
    <keyword>Community-based Participatory Research</keyword>
    <keyword>Minnesota</keyword>
    <keyword>Ethnic and Racial Minorities</keyword>
    <keyword>Women's Health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Opioid-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>
  
  
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/NCT05995886
  org study id: 23-005038
  secondary id: DA40316-08S2
  nct id: NCT05995886
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to find out whether a Facebook group will help Native women in
        recovery from opioid use.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Feasibility of Facebook Intervention
  time frame: 3 months
  description: The study team will measure the feasibility from the combined reports of recruitment, study retention, level of Facebook intervention uptake/engagement, and treatment satisfaction.
  measure: Timeline Follow-back Interview and UDS to measure Opioid Abstinence
  time frame: 6 months
  description: The study team will explore the preliminary differential impact of the intervention compared with the control condition on opioid abstinence and MOUD continuation. Opioid and other substance use will be assessed through monthly Timeline Follow-Back (TLFB) interviews (Sobell & Sobell, 1992; Wray et al., 2016). At 1, 3, and 6-months, the study team will obtain a UDS that will be used along with the TLFB interviews to measure opioid abstinence.
  measure: Reporting MOUD continuation
  time frame: 6 months
  description: The study team will summarize MOUD continuation as the proportion of participants reporting current use at 6-month follow-up.
  measure: Perceived Stress Scale and Communal Mastery Scale
  time frame: 3 months
  description: The study team will explore the differential impact of the intervention compared with the control condition on constructs targeted by our intervention, specifically perceived stress and coping with stressful life circumstances from a more collectivist orientation, respectively.
  arm group label: Wiidookaage'win Facebook Group
  arm group type: Experimental
  description: The Wiidookaage'win Facebook Group is an online, asynchronous group intervention that will run for 3-months with approximately 30 days of content developed. It is private and hidden, meaning only those in the study will be able to see or find the group. It will be moderated by two women from the study team (one AIAN and one biracial). A back-up moderator will also have access to the group. Participants will be able to comment, react, view, and post in the intervention group, and are encouraged to interact with one another.
  arm group label: Online Resources Landing Page
  arm group type: No Intervention
  description: The Online Resources Landing Page was developed by the study team using https://carrd.co. It includes links to local programs in family services, substance use recovery, legal advocacy, etc. which already exist and may help support their recovery.
  intervention type: Behavioral
  intervention name: Wiidookaage'win Facebook Group
  description: An online social media group program that incorporates social support, mindfulness-based, and cultural practices that may support OUD recovery.
  arm group label: Wiidookaage'win Facebook Group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Participants may be cisgender or transgender women. They may also identify as Two Spirit and include "woman" as part of their gender identity.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christi A Patten, PhD
  role: Principal Investigator
  affiliation: Mayo Clinic
  last name: Antonia M Young, BA
  phone: 1-833-880-2600
  email: wiidookaagewin@mayo.edu
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Christi Patten
  investigator title: Professor of Psychology
  mesh term: Opioid-Related Disorders
  sharing ipd: No