<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/NCT04460027</url>
  </required_header>
  <id_info>
    <org_study_id>56439</org_study_id>
    <secondary_id>4R44DA048712-02</secondary_id>
    <nct_id>NCT04460027</nct_id>
  </id_info>
  <brief_title>W-SUDs for COVID-19</brief_title>
  <official_title>Woebot for Substance Use Disorders During COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Woebot Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Woebot 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 test the efficacy of a substance use disorder intervention&#xD;
      delivered via a mobile application in an adult population during the COVID-19 pandemic.&#xD;
&#xD;
      This study that will test the comparative efficacy of the mobile-app based substance use&#xD;
      disorder program to reduce substance use relative to a wait list control condition, and&#xD;
      explore between group differences on quality of life indices as well as retention and&#xD;
      engagement during COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <phase>Phase 1</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks</measure>
    <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
    <description>Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks</measure>
    <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
    <description>Measure of substance use problems. The SIP-AD assesses substance use problems in the past 30 days. Total score consists of of the sum of all 15 items, ranging from 0-45, where greater scores indicate greater substance use problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks</measure>
    <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
    <description>Measure of drug abuse related consequences. The DAST-10 is a brief, 10-item self-report measure that assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity. Adapted from past 12 months to past 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks</measure>
    <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
    <description>Measure of self-confidence. The 8-item BSCQ is a state dependent measure that assesses self-confidence to resist the urge to drink heavily or use drugs in a variety of situations. Each of the 8 scale situations consists of a 100-mm line, anchored by 0% (&quot;not at all confident&quot;) and 100% (&quot;totally confident&quot;) where clients are asked to indicate confidence on a scale from 0% to 100%. Higher scores are associated with greater confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks</measure>
    <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
    <description>A one-item, self-reported rating of craving intensity to use substances over the past 7 days. Score ranges is from 0-4, where a greater score indicates a more intense urge to use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks</measure>
    <time_frame>Change from Baseline to Post-treatment at 8 Weeks</time_frame>
    <description>A one item, self-reported rating of pain. Scores range from 0-100 where higher scores indicate greater levels of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks</measure>
    <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
    <description>Measure of depression. An 8-item self-report questionnaire that assesses the frequency and severity of depression symptoms. Total scores range from 0 to 24 where higher scores indicate greater levels of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks</measure>
    <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
    <description>Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks</measure>
    <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
    <description>Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact, and growth. Possible total score range from 0-22, where greater scores are related to greater impact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks</measure>
    <time_frame>Post-treatment (8 weeks from Baseline)</time_frame>
    <description>Measure of satisfaction. An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale. Example questions include, &quot;How would you rate the quality of service you received&quot;? and &quot;Did you get the kind of service you wanted?&quot; Total sums range from 8-32, with high scores indicating greater satisfaction with the W-SUDs mobile application.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks</measure>
    <time_frame>Post-treatment (8 weeks from Baseline)</time_frame>
    <description>Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Total scores range from 6-36, where greater scores indicate greater intervention acceptability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks</measure>
    <time_frame>Post-treatment (8 weeks from Baseline)</time_frame>
    <description>Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Total scores range from 6-36, where greater scores indicate greater intervention feasibility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks</measure>
    <time_frame>Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks</time_frame>
    <description>Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Total scores range from 12-60, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing &quot;therapist&quot; with &quot;Woebot&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Substance Use Disorders</condition>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>W-SUDs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait List Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Woebot Substance Use Disorder</intervention_name>
    <description>Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
    <arm_group_label>W-SUDs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All genders aged 18-65 years&#xD;
&#xD;
          -  Access to a smartphone&#xD;
&#xD;
          -  Available and committed to engage with app and complete assessments&#xD;
&#xD;
          -  Be willing to provide email address (as this is how assessment incentives will be&#xD;
             distributed),&#xD;
&#xD;
          -  Literate in English (as W-SUDs conversational and video materials will be in English).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of&#xD;
             this population)&#xD;
&#xD;
          -  History of severe drug/alcohol use&#xD;
&#xD;
          -  History of opioid misuse without medication-assisted treatment&#xD;
&#xD;
          -  Suicide attempt within the past year&#xD;
&#xD;
          -  Opioid overdose within the past year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <results_first_submitted>July 19, 2022</results_first_submitted>
  <results_first_submitted_qc>November 23, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 21, 2022</results_first_posted>
  <last_update_submitted>November 23, 2022</last_update_submitted>
  <last_update_submitted_qc>November 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</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>Substance-Related Disorders</mesh_term>
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 30, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT04460027/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT04460027/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT04460027/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>W-SUDs</title>
          <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
        </group>
        <group group_id="P2">
          <title>Waitlist Control</title>
          <description>Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>W-SUDs</title>
          <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
        </group>
        <group group_id="B2">
          <title>Wait List Control</title>
          <description>Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="88"/>
            <count group_id="B2" value="92"/>
            <count group_id="B3" value="180"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.8" spread="12.1"/>
                    <measurement group_id="B2" value="39.8" spread="11.2"/>
                    <measurement group_id="B3" value="40.3" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks</title>
        <description>Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks</description>
        <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Control</title>
            <description>Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks</title>
          <description>Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks</description>
          <units>occasions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.1" spread="2.0"/>
                    <measurement group_id="O2" value="-4.7" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks</title>
        <description>Measure of substance use problems. The SIP-AD assesses substance use problems in the past 30 days. Total score consists of of the sum of all 15 items, ranging from 0-45, where greater scores indicate greater substance use problems.</description>
        <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
          <group group_id="O2">
            <title>Wait List Control</title>
            <description>Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks</title>
          <description>Measure of substance use problems. The SIP-AD assesses substance use problems in the past 30 days. Total score consists of of the sum of all 15 items, ranging from 0-45, where greater scores indicate greater substance use problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="1.1"/>
                    <measurement group_id="O2" value="-4.7" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks</title>
        <description>Measure of drug abuse related consequences. The DAST-10 is a brief, 10-item self-report measure that assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity. Adapted from past 12 months to past 30 days.</description>
        <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
          <group group_id="O2">
            <title>Wait List Control</title>
            <description>Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks</title>
          <description>Measure of drug abuse related consequences. The DAST-10 is a brief, 10-item self-report measure that assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity. Adapted from past 12 months to past 30 days.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.8"/>
                    <measurement group_id="O2" value="2.2" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks</title>
        <description>Measure of self-confidence. The 8-item BSCQ is a state dependent measure that assesses self-confidence to resist the urge to drink heavily or use drugs in a variety of situations. Each of the 8 scale situations consists of a 100-mm line, anchored by 0% (&quot;not at all confident&quot;) and 100% (&quot;totally confident&quot;) where clients are asked to indicate confidence on a scale from 0% to 100%. Higher scores are associated with greater confidence.</description>
        <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
          <group group_id="O2">
            <title>Wait List Control</title>
            <description>Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks</title>
          <description>Measure of self-confidence. The 8-item BSCQ is a state dependent measure that assesses self-confidence to resist the urge to drink heavily or use drugs in a variety of situations. Each of the 8 scale situations consists of a 100-mm line, anchored by 0% (&quot;not at all confident&quot;) and 100% (&quot;totally confident&quot;) where clients are asked to indicate confidence on a scale from 0% to 100%. Higher scores are associated with greater confidence.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" spread="3.4"/>
                    <measurement group_id="O2" value="5.3" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks</title>
        <description>A one-item, self-reported rating of craving intensity to use substances over the past 7 days. Score ranges is from 0-4, where a greater score indicates a more intense urge to use.</description>
        <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
          <group group_id="O2">
            <title>Wait List Control</title>
            <description>Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks</title>
          <description>A one-item, self-reported rating of craving intensity to use substances over the past 7 days. Score ranges is from 0-4, where a greater score indicates a more intense urge to use.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.5" spread=".1"/>
                    <measurement group_id="O2" value="-.4" spread=".1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks</title>
        <description>A one item, self-reported rating of pain. Scores range from 0-100 where higher scores indicate greater levels of pain.</description>
        <time_frame>Change from Baseline to Post-treatment at 8 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
          <group group_id="O2">
            <title>Wait List Control</title>
            <description>Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks</title>
          <description>A one item, self-reported rating of pain. Scores range from 0-100 where higher scores indicate greater levels of pain.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="2.8"/>
                    <measurement group_id="O2" value="-.8" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks</title>
        <description>Measure of depression. An 8-item self-report questionnaire that assesses the frequency and severity of depression symptoms. Total scores range from 0 to 24 where higher scores indicate greater levels of depression.</description>
        <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
          <group group_id="O2">
            <title>Wait List Control</title>
            <description>Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks</title>
          <description>Measure of depression. An 8-item self-report questionnaire that assesses the frequency and severity of depression symptoms. Total scores range from 0 to 24 where higher scores indicate greater levels of depression.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread=".6"/>
                    <measurement group_id="O2" value="-1.7" spread=".6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks</title>
        <description>Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety.</description>
        <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
          <group group_id="O2">
            <title>Wait List Control</title>
            <description>Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks</title>
          <description>Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread=".6"/>
                    <measurement group_id="O2" value="-.7" spread=".5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks</title>
        <description>Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact, and growth. Possible total score range from 0-22, where greater scores are related to greater impact.</description>
        <time_frame>Change from Baseline to Post-treatment at 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
          <group group_id="O2">
            <title>Wait List Control</title>
            <description>Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks</title>
          <description>Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact, and growth. Possible total score range from 0-22, where greater scores are related to greater impact.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread=".5"/>
                    <measurement group_id="O2" value="-1.4" spread=".5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks</title>
        <description>Measure of satisfaction. An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale. Example questions include, &quot;How would you rate the quality of service you received&quot;? and &quot;Did you get the kind of service you wanted?&quot; Total sums range from 8-32, with high scores indicating greater satisfaction with the W-SUDs mobile application.</description>
        <time_frame>Post-treatment (8 weeks from Baseline)</time_frame>
        <population>This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.</population>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
        </group_list>
        <measure>
          <title>Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks</title>
          <description>Measure of satisfaction. An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale. Example questions include, &quot;How would you rate the quality of service you received&quot;? and &quot;Did you get the kind of service you wanted?&quot; Total sums range from 8-32, with high scores indicating greater satisfaction with the W-SUDs mobile application.</description>
          <population>This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks</title>
        <description>Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Total scores range from 6-36, where greater scores indicate greater intervention acceptability.</description>
        <time_frame>Post-treatment (8 weeks from Baseline)</time_frame>
        <population>This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.</population>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
        </group_list>
        <measure>
          <title>Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks</title>
          <description>Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Total scores range from 6-36, where greater scores indicate greater intervention acceptability.</description>
          <population>This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks</title>
        <description>Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Total scores range from 6-36, where greater scores indicate greater intervention feasibility.</description>
        <time_frame>Post-treatment (8 weeks from Baseline)</time_frame>
        <population>This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.</population>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
        </group_list>
        <measure>
          <title>Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks</title>
          <description>Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Total scores range from 6-36, where greater scores indicate greater intervention feasibility.</description>
          <population>This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.0" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks</title>
        <description>Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Total scores range from 12-60, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing &quot;therapist&quot; with &quot;Woebot&quot;.</description>
        <time_frame>Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks</time_frame>
        <population>This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.</population>
        <group_list>
          <group group_id="O1">
            <title>W-SUDs</title>
            <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks</title>
          <description>Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Total scores range from 12-60, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing &quot;therapist&quot; with &quot;Woebot&quot;.</description>
          <population>This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious adverse events were assessed at post-treatment, 8 weeks from baseline.</time_frame>
      <desc>Serious adverse events occurring during treatment were assessed for hospitalization related to substance use, suicide attempt, alcohol or drug overdose, and severe withdrawal (eg, delirium tremens). Positive endorsements were followed up with questions about the timing, diagnosis, and resolution. If additional details were needed to determine whether the event was study related, a team member reached out to the participant.</desc>
      <group_list>
        <group group_id="E1">
          <title>W-SUDs</title>
          <description>Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.</description>
        </group>
        <group group_id="E2">
          <title>Wait List Control</title>
          <description>Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <description>Hospitalization for alcohol detoxification</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Judith J. Prochaska, PhD</name_or_title>
      <organization>Stanford Prevention Research Center, Department of Medicine, Stanford University</organization>
      <phone>650-724-3608</phone>
      <email>jpro@stanford.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04460027
org study id: 56439
secondary id: 4R44DA048712-02
nct id: NCT04460027
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the efficacy of a substance use disorder intervention
      delivered via a mobile application in an adult population during the COVID-19 pandemic.

      This study that will test the comparative efficacy of the mobile-app based substance use
      disorder program to reduce substance use relative to a wait list control condition, and
      explore between group differences on quality of life indices as well as retention and
      engagement during COVID-19.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks
time frame: Change from Baseline to Post-treatment at 8 weeks
description: Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks
measure: Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks
time frame: Change from Baseline to Post-treatment at 8 weeks
description: Measure of substance use problems. The SIP-AD assesses substance use problems in the past 30 days. Total score consists of of the sum of all 15 items, ranging from 0-45, where greater scores indicate greater substance use problems.
measure: Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks
time frame: Change from Baseline to Post-treatment at 8 weeks
description: Measure of drug abuse related consequences. The DAST-10 is a brief, 10-item self-report measure that assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity. Adapted from past 12 months to past 30 days.
measure: Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks
time frame: Change from Baseline to Post-treatment at 8 weeks
description: Measure of self-confidence. The 8-item BSCQ is a state dependent measure that assesses self-confidence to resist the urge to drink heavily or use drugs in a variety of situations. Each of the 8 scale situations consists of a 100-mm line, anchored by 0% ("not at all confident") and 100% ("totally confident") where clients are asked to indicate confidence on a scale from 0% to 100%. Higher scores are associated with greater confidence.
measure: Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks
time frame: Change from Baseline to Post-treatment at 8 weeks
description: A one-item, self-reported rating of craving intensity to use substances over the past 7 days. Score ranges is from 0-4, where a greater score indicates a more intense urge to use.
measure: Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks
time frame: Change from Baseline to Post-treatment at 8 Weeks
description: A one item, self-reported rating of pain. Scores range from 0-100 where higher scores indicate greater levels of pain.
measure: Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks
time frame: Change from Baseline to Post-treatment at 8 weeks
description: Measure of depression. An 8-item self-report questionnaire that assesses the frequency and severity of depression symptoms. Total scores range from 0 to 24 where higher scores indicate greater levels of depression.
measure: Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks
time frame: Change from Baseline to Post-treatment at 8 weeks
description: Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety.
measure: Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks
time frame: Change from Baseline to Post-treatment at 8 weeks
description: Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact, and growth. Possible total score range from 0-22, where greater scores are related to greater impact.
measure: Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks
time frame: Post-treatment (8 weeks from Baseline)
description: Measure of satisfaction. An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale. Example questions include, "How would you rate the quality of service you received"? and "Did you get the kind of service you wanted?" Total sums range from 8-32, with high scores indicating greater satisfaction with the W-SUDs mobile application.
measure: Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks
time frame: Post-treatment (8 weeks from Baseline)
description: Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Total scores range from 6-36, where greater scores indicate greater intervention acceptability.
measure: Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks
time frame: Post-treatment (8 weeks from Baseline)
description: Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Total scores range from 6-36, where greater scores indicate greater intervention feasibility.
measure: Change in Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks
time frame: Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks
description: Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Total scores range from 12-60, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing "therapist" with "Woebot".
arm group label: W-SUDs
arm group type: Experimental
arm group label: Wait List Control
arm group type: No Intervention
intervention type: Other
intervention name: Woebot Substance Use Disorder
description: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
arm group label: W-SUDs
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Alcoholism
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 