<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/NCT04447794</url>
  </required_header>
  <id_info>
    <org_study_id>1521800-2</org_study_id>
    <nct_id>NCT04447794</nct_id>
  </id_info>
  <brief_title>Step Away: Comparing a Chatbot-delivered Alcohol Intervention With a Smartphone App</brief_title>
  <official_title>Can a Chatbot-delivered Alcohol Intervention Engage Users and Enhance Outcomes Over a Smartphone App? Development and Feasibility Testing of a StepAway 'Bot'</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alaska Anchorage</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alaska Anchorage</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>
      A wide gap exists between the number of people needing alcohol treatment and those actually&#xD;
      receiving it. This study builds on a previous one that indicated that smartphone-based&#xD;
      intervention can help increase the number of people who receive alcohol intervention services&#xD;
      and decrease treatment barriers. Improvements to the previously developed app, Step Away,&#xD;
      will be made. In addition, a new method of delivering the Step Away intervention via an&#xD;
      online, interactive chatbot, will be developed with the goal of improving engagement and&#xD;
      effectiveness. Participants will be recruited and outcomes between the two interventions&#xD;
      examined to determine if the Step Away chatbot has enhanced user engagement, intervention&#xD;
      fidelity and outcome efficacy in comparison to the Step Away app amongst a group of problem&#xD;
      drinkers. Participants will also be interviewed to determine their perceptions of both&#xD;
      interventions with a view towards understanding barriers to user engagement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A wide gap exists between the number of individuals needing alcohol treatment and those&#xD;
      actually receiving it. Technologically-delivered interventions may dramatically increase the&#xD;
      number of individuals who receive needed alcohol intervention services due to their ability&#xD;
      to circumvent treatment barriers. Smartphones are the ideal devices to provide&#xD;
      empirically-supported intervention assistance whenever and wherever it is needed. Our&#xD;
      research team previously developed and tested a stand-alone, self-administered&#xD;
      smartphone-based intervention system for alcohol use disorders that was based on empirically&#xD;
      supported face-to-face treatments (the Location-Based Monitoring and Intervention for Alcohol&#xD;
      Use Disorders (LBMI-A) system). A revised and improved iPhone-based version, Step Away, was&#xD;
      developed. Step Away usage data indicate that user engagement with modules that are not&#xD;
      &quot;pushed&quot; to the user is relatively low, which is a problem that many health apps experience.&#xD;
      A new method of delivering Step Away through an artificially intelligent (AI) chatbot will be&#xD;
      developed that holds potential for providing enhanced user engagement and effectiveness as it&#xD;
      can reach out through a text interface to introduce new intervention steps and respond to the&#xD;
      user with Step Away's in-the-moment help with having a craving, experiencing distress or&#xD;
      needing social support. The first phase of this study will focus on developing a Step Away&#xD;
      chatbot and enhance the existing Step Away app's user interface. The second phase will entail&#xD;
      a pilot study to determine if the Step Away chatbot has enhanced user engagement,&#xD;
      intervention fidelity and outcome efficacy in comparison to the Step Away app amongst a group&#xD;
      of problem drinkers. Participants will be interviewed to determine their perceptions of both&#xD;
      interventions with a view towards understanding barriers to user engagement. Finally, this&#xD;
      project will set the stage for a further, large-scale evaluation of Step Away, the content of&#xD;
      which will be determined by the outcome of the pilot study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Actual">January 6, 2021</completion_date>
  <primary_completion_date type="Actual">January 6, 2021</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Alcohol Consumption (Drinks Per Day)</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Alcohol-Related Problems</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The Short Inventory of Problems - Revised (SIP-R) is a self-report inventory of adverse consequences associated with drug and alcohol use. It is comprised of 17 questions scored on a 4-point Likert scale from 1 (never) to 4 (daily or almost daily). Item responses are summed to produce a total score and five subscale scores (physical, intrapersonal, social responsibility, interpersonal, and impulse control). Higher scores indicate more life problems related to alcohol use. In populations of problem drinkers, the SIP-R has demonstrated good concurrent validity and internal consistency. The SIP-R will be administered at baseline and follow-up to examine between group changes over time. Scale ranges from 17 to 68.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Alcohol Consumption (Heavy Drinking Days)</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Alcohol Consumption (Percentage of Days Abstinent)</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Readiness to Change</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Given that the main underlying theoretical framework of Step Away is motivational enhancement (ME), we want to examine readiness to change as a mediating variable. We will utilize the Readiness to Change Treatment Version (RCQTV) in this study to assess this construct. The RCQTV has been shown to have solid reliability and validity and has been modified for individuals contemplating or engaged in treatment for alcohol problems. Scale ranges from -8 to 8; higher scores represent higher motivation to change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention Utilization Data</measure>
    <time_frame>16 weeks</time_frame>
    <description>Intervention utilization data is used to calculate how frequently participants used the app or the chatbot during the study period. Means and standard deviations will be used to calculate this measure. Unit of measure is the number of times a user clicked on the app or the chabot during the study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative Perceptions of Step Away App and Chatbot</measure>
    <time_frame>16 weeks</time_frame>
    <description>Retrospective qualitative interviews conducted with 10 chatbot and 10 app users to understand how they used technology and their recommendations for improving the experience. Semi-structured interviews were conducted with participants who had completed follow-up assessments. Participants were purposefully selected to maximize variation in the app (n=10) or the chatbot (n=10) usage. Eleven core interview questions were asked of both app and chatbot users, plus an additional chatbot user question about their experience with and impressions of the chatbot's conversational quality. A random number generator was used to select the 5 high users and 5 low users of each intervention. Qualitative analysis software was used to identify themes related to perceived helpfulness, barriers, motivators, and improvements; key themes related to these topics are reported here. No quantitative data were collected during the interviews.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">191</enrollment>
  <condition>Alcohol Consumption</condition>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Step Away App</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Step Away Chatbot</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Step Away App Delay</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Step Away Chatbot</intervention_name>
    <description>The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.&#xD;
The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
    <arm_group_label>Step Away Chatbot</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Step Away App</intervention_name>
    <description>The Step Away app is a smartphone-based mobile intervention system.&#xD;
It is informed by three theoretical constructs that are considered the most important &quot;active ingredients&quot; for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
    <arm_group_label>Step Away App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being 18 years of age or older&#xD;
&#xD;
          -  being a problem drinker, i.e., having a score of 8 or higher for men and 6 or higher&#xD;
             for women on the United States Alcohol Use Disorders Identification Test (USAUDIT)&#xD;
&#xD;
          -  drinking 5 or more (for men ages 18-65), or 4 or more (for women and men over age 65),&#xD;
             standard drinks on at least one occasion during the last 90 day&#xD;
&#xD;
          -  owning either an iPhone or Android smartphone with an accompanying cellular and data&#xD;
             plan&#xD;
&#xD;
          -  U.S. residency&#xD;
&#xD;
          -  able to read and text in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  being more than 30 days abstinent at baseline&#xD;
&#xD;
          -  being in alcohol or drug abuse treatment currently&#xD;
&#xD;
          -  being pregnant or nursing&#xD;
&#xD;
          -  having a moderate to severe level of alcohol use disorder, i.e., having a score of 20&#xD;
             or higher on the USAUDIT&#xD;
&#xD;
          -  unwilling or unable to complete follow-up assessment&#xD;
&#xD;
          -  non-U.S. residency&#xD;
&#xD;
          -  unable to read or text in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Dulin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alaska Anchorage</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alaska Anchorage</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dulin PL, Gonzalez VM, Campbell K. Results of a pilot test of a self-administered smartphone-based treatment system for alcohol use disorders: usability and early outcomes. Subst Abus. 2014;35(2):168-75. doi: 10.1080/08897077.2013.821437.</citation>
    <PMID>24821354</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <results_first_submitted>December 16, 2021</results_first_submitted>
  <results_first_submitted_qc>November 1, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 1, 2023</results_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</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>
  <keyword>alcohol use disorder</keyword>
  <keyword>alcohol consumption</keyword>
  <keyword>primary prevention</keyword>
  <keyword>smartphone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT04447794/Prot_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>May 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT04447794/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Step Away App</title>
          <description>Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.&#xD;
Step Away App: The Step Away app is a smartphone-based mobile intervention system.&#xD;
It is informed by three theoretical constructs that are considered the most important &quot;active ingredients&quot; for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
        </group>
        <group group_id="P2">
          <title>Step Away Chatbot</title>
          <description>Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.&#xD;
Step Away Chatbot: The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.&#xD;
The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
        </group>
        <group group_id="P3">
          <title>Step Away App Delay</title>
          <description>Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="64"/>
                <participants group_id="P3" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Step Away App</title>
          <description>Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.&#xD;
Step Away App: The Step Away app is a smartphone-based mobile intervention system.&#xD;
It is informed by three theoretical constructs that are considered the most important &quot;active ingredients&quot; for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
        </group>
        <group group_id="B2">
          <title>Step Away Chatbot</title>
          <description>Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.&#xD;
Step Away Chatbot: The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.&#xD;
The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
        </group>
        <group group_id="B3">
          <title>Step Away App Delay</title>
          <description>Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.</description>
        </group>
        <group group_id="B4">
          <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="64"/>
            <count group_id="B2" value="64"/>
            <count group_id="B3" value="63"/>
            <count group_id="B4" value="191"/>
          </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="41.64" spread="13.13"/>
                    <measurement group_id="B2" value="39.55" spread="12.30"/>
                    <measurement group_id="B3" value="39.68" spread="12.46"/>
                    <measurement group_id="B4" value="40.29" spread="12.61"/>
                  </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="34"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Causasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alaska Native or American Indian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latinx</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Alcohol Consumption (Drinks Per Day)</title>
        <description>The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Of the 150 participants analyzed, only 114 provided TLFB data.</population>
        <group_list>
          <group group_id="O1">
            <title>Step Away App</title>
            <description>Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.&#xD;
Step Away App: The Step Away app is a smartphone-based mobile intervention system.&#xD;
It is informed by three theoretical constructs that are considered the most important &quot;active ingredients&quot; for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
          <group group_id="O2">
            <title>Step Away Chatbot</title>
            <description>Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.&#xD;
Step Away Chatbot: The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.&#xD;
The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
          <group group_id="O3">
            <title>Step Away Delay</title>
            <description>Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Alcohol Consumption (Drinks Per Day)</title>
          <description>The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.</description>
          <population>Of the 150 participants analyzed, only 114 provided TLFB data.</population>
          <units>drinks per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.18" spread="1.48"/>
                    <measurement group_id="O2" value="-0.90" spread="0.96"/>
                    <measurement group_id="O3" value="-0.63" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Alcohol-Related Problems</title>
        <description>The Short Inventory of Problems - Revised (SIP-R) is a self-report inventory of adverse consequences associated with drug and alcohol use. It is comprised of 17 questions scored on a 4-point Likert scale from 1 (never) to 4 (daily or almost daily). Item responses are summed to produce a total score and five subscale scores (physical, intrapersonal, social responsibility, interpersonal, and impulse control). Higher scores indicate more life problems related to alcohol use. In populations of problem drinkers, the SIP-R has demonstrated good concurrent validity and internal consistency. The SIP-R will be administered at baseline and follow-up to examine between group changes over time. Scale ranges from 17 to 68.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Step Away App</title>
            <description>Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.&#xD;
Step Away App: The Step Away app is a smartphone-based mobile intervention system.&#xD;
It is informed by three theoretical constructs that are considered the most important &quot;active ingredients&quot; for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
          <group group_id="O2">
            <title>Step Away Chatbot</title>
            <description>Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.&#xD;
Step Away Chatbot: The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.&#xD;
The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
          <group group_id="O3">
            <title>Step Away App Delay</title>
            <description>Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Alcohol-Related Problems</title>
          <description>The Short Inventory of Problems - Revised (SIP-R) is a self-report inventory of adverse consequences associated with drug and alcohol use. It is comprised of 17 questions scored on a 4-point Likert scale from 1 (never) to 4 (daily or almost daily). Item responses are summed to produce a total score and five subscale scores (physical, intrapersonal, social responsibility, interpersonal, and impulse control). Higher scores indicate more life problems related to alcohol use. In populations of problem drinkers, the SIP-R has demonstrated good concurrent validity and internal consistency. The SIP-R will be administered at baseline and follow-up to examine between group changes over time. Scale ranges from 17 to 68.</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="55"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.53" spread="5.54"/>
                    <measurement group_id="O2" value="-2.82" spread="11.39"/>
                    <measurement group_id="O3" value="-3.98" spread="7.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Alcohol Consumption (Heavy Drinking Days)</title>
        <description>The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Step Away App</title>
            <description>Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.&#xD;
Step Away App: The Step Away app is a smartphone-based mobile intervention system.&#xD;
It is informed by three theoretical constructs that are considered the most important &quot;active ingredients&quot; for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
          <group group_id="O2">
            <title>Step Away Chatbot</title>
            <description>Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.&#xD;
Step Away Chatbot: The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.&#xD;
The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
          <group group_id="O3">
            <title>Step Away Delay</title>
            <description>Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Alcohol Consumption (Heavy Drinking Days)</title>
          <description>The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.</description>
          <units>heavy drinking days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.40" spread="7.28"/>
                    <measurement group_id="O2" value="-3.95" spread="5.70"/>
                    <measurement group_id="O3" value="-1.36" spread="6.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Alcohol Consumption (Percentage of Days Abstinent)</title>
        <description>The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Step Away App</title>
            <description>Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.&#xD;
Step Away App: The Step Away app is a smartphone-based mobile intervention system.&#xD;
It is informed by three theoretical constructs that are considered the most important &quot;active ingredients&quot; for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
          <group group_id="O2">
            <title>Step Away Chatbot</title>
            <description>Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.&#xD;
Step Away Chatbot: The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.&#xD;
The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
          <group group_id="O3">
            <title>Step Away Delay</title>
            <description>Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Alcohol Consumption (Percentage of Days Abstinent)</title>
          <description>The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.</description>
          <units>percentage of days abstinent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.60" spread="28.97"/>
                    <measurement group_id="O2" value="14.02" spread="22.05"/>
                    <measurement group_id="O3" value="17.37" spread="32.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Readiness to Change</title>
        <description>Given that the main underlying theoretical framework of Step Away is motivational enhancement (ME), we want to examine readiness to change as a mediating variable. We will utilize the Readiness to Change Treatment Version (RCQTV) in this study to assess this construct. The RCQTV has been shown to have solid reliability and validity and has been modified for individuals contemplating or engaged in treatment for alcohol problems. Scale ranges from -8 to 8; higher scores represent higher motivation to change.</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Step Away App</title>
            <description>Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.&#xD;
Step Away App: The Step Away app is a smartphone-based mobile intervention system.&#xD;
It is informed by three theoretical constructs that are considered the most important &quot;active ingredients&quot; for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
          <group group_id="O2">
            <title>Step Away Chatbot</title>
            <description>Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.&#xD;
Step Away Chatbot: The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.&#xD;
The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
          <group group_id="O3">
            <title>Step Away Delay</title>
            <description>Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Readiness to Change</title>
          <description>Given that the main underlying theoretical framework of Step Away is motivational enhancement (ME), we want to examine readiness to change as a mediating variable. We will utilize the Readiness to Change Treatment Version (RCQTV) in this study to assess this construct. The RCQTV has been shown to have solid reliability and validity and has been modified for individuals contemplating or engaged in treatment for alcohol problems. Scale ranges from -8 to 8; higher scores represent higher motivation to change.</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="55"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.76"/>
                    <measurement group_id="O2" value="0.48" spread="0.74"/>
                    <measurement group_id="O3" value="0.00" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intervention Utilization Data</title>
        <description>Intervention utilization data is used to calculate how frequently participants used the app or the chatbot during the study period. Means and standard deviations will be used to calculate this measure. Unit of measure is the number of times a user clicked on the app or the chabot during the study period.</description>
        <time_frame>16 weeks</time_frame>
        <population>Delay group did not have access to either intervention during the study period.</population>
        <group_list>
          <group group_id="O1">
            <title>Step Away App</title>
            <description>Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.&#xD;
Step Away App: The Step Away app is a smartphone-based mobile intervention system.&#xD;
It is informed by three theoretical constructs that are considered the most important &quot;active ingredients&quot; for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
          <group group_id="O2">
            <title>Step Away Chatbot</title>
            <description>Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.&#xD;
Step Away Chatbot: The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.&#xD;
The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
        </group_list>
        <measure>
          <title>Intervention Utilization Data</title>
          <description>Intervention utilization data is used to calculate how frequently participants used the app or the chatbot during the study period. Means and standard deviations will be used to calculate this measure. Unit of measure is the number of times a user clicked on the app or the chabot during the study period.</description>
          <population>Delay group did not have access to either intervention during the study period.</population>
          <units>User clicks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.96" spread="38.16"/>
                    <measurement group_id="O2" value="24.56" spread="28.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Qualitative Perceptions of Step Away App and Chatbot</title>
        <description>Retrospective qualitative interviews conducted with 10 chatbot and 10 app users to understand how they used technology and their recommendations for improving the experience. Semi-structured interviews were conducted with participants who had completed follow-up assessments. Participants were purposefully selected to maximize variation in the app (n=10) or the chatbot (n=10) usage. Eleven core interview questions were asked of both app and chatbot users, plus an additional chatbot user question about their experience with and impressions of the chatbot's conversational quality. A random number generator was used to select the 5 high users and 5 low users of each intervention. Qualitative analysis software was used to identify themes related to perceived helpfulness, barriers, motivators, and improvements; key themes related to these topics are reported here. No quantitative data were collected during the interviews.</description>
        <time_frame>16 weeks</time_frame>
        <population>This outcome measure explored the perceptions and experiences of the users of the app and the chatbot The delay group were not provided access to either the app or the chatbot during the intervention period so they were not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Step Away App</title>
            <description>Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.&#xD;
Step Away App: The Step Away app is a smartphone-based mobile intervention system.&#xD;
It is informed by three theoretical constructs that are considered the most important &quot;active ingredients&quot; for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
          <group group_id="O2">
            <title>Step Away Chatbot</title>
            <description>Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.&#xD;
Step Away Chatbot: The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.&#xD;
The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
          </group>
        </group_list>
        <measure>
          <title>Qualitative Perceptions of Step Away App and Chatbot</title>
          <description>Retrospective qualitative interviews conducted with 10 chatbot and 10 app users to understand how they used technology and their recommendations for improving the experience. Semi-structured interviews were conducted with participants who had completed follow-up assessments. Participants were purposefully selected to maximize variation in the app (n=10) or the chatbot (n=10) usage. Eleven core interview questions were asked of both app and chatbot users, plus an additional chatbot user question about their experience with and impressions of the chatbot's conversational quality. A random number generator was used to select the 5 high users and 5 low users of each intervention. Qualitative analysis software was used to identify themes related to perceived helpfulness, barriers, motivators, and improvements; key themes related to these topics are reported here. No quantitative data were collected during the interviews.</description>
          <population>This outcome measure explored the perceptions and experiences of the users of the app and the chatbot The delay group were not provided access to either the app or the chatbot during the intervention period so they were not included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall Experience as User</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Things Users Learned from Use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Mini-Modules</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Prompts for Use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Ability to Anticipate Triggers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Conversation Quality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Personalization to User</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Thing That Support Sustainability of Use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Things That Prevent Sustainability of Use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Human Contact Encouraging Use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Impact of Pandemic on Use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Recommended Changes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Other Thoughts on Experience</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Things Helpful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Things Not Helpful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Facebook Platform</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Lack of Self-Direction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Notifications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Lack of Prompts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention Related to Repetitive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention Related to Set Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Technology Glitch</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Unhelpful Tips or Strategies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Mention of Usability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Step Away App</title>
          <description>Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.&#xD;
Step Away App: The Step Away app is a smartphone-based mobile intervention system.&#xD;
It is informed by three theoretical constructs that are considered the most important &quot;active ingredients&quot; for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
        </group>
        <group group_id="E2">
          <title>Step Away Chatbot</title>
          <description>Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.&#xD;
Step Away Chatbot: The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.&#xD;
The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.</description>
        </group>
        <group group_id="E3">
          <title>Step Away App Delay</title>
          <description>Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.</description>
        </group>
      </group_list>
      <serious_events>
        <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="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="63"/>
              </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="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Patrick Dulin</name_or_title>
      <organization>University of Alaska Anchorage</organization>
      <phone>(907) 786-1653</phone>
      <email>pldulin@alaska.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/NCT04447794
org study id: 1521800-2
nct id: NCT04447794
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A wide gap exists between the number of people needing alcohol treatment and those actually
      receiving it. This study builds on a previous one that indicated that smartphone-based
      intervention can help increase the number of people who receive alcohol intervention services
      and decrease treatment barriers. Improvements to the previously developed app, Step Away,
      will be made. In addition, a new method of delivering the Step Away intervention via an
      online, interactive chatbot, will be developed with the goal of improving engagement and
      effectiveness. Participants will be recruited and outcomes between the two interventions
      examined to determine if the Step Away chatbot has enhanced user engagement, intervention
      fidelity and outcome efficacy in comparison to the Step Away app amongst a group of problem
      drinkers. Participants will also be interviewed to determine their perceptions of both
      interventions with a view towards understanding barriers to user engagement.
A wide gap exists between the number of individuals needing alcohol treatment and those
      actually receiving it. Technologically-delivered interventions may dramatically increase the
      number of individuals who receive needed alcohol intervention services due to their ability
      to circumvent treatment barriers. Smartphones are the ideal devices to provide
      empirically-supported intervention assistance whenever and wherever it is needed. Our
      research team previously developed and tested a stand-alone, self-administered
      smartphone-based intervention system for alcohol use disorders that was based on empirically
      supported face-to-face treatments (the Location-Based Monitoring and Intervention for Alcohol
      Use Disorders (LBMI-A) system). A revised and improved iPhone-based version, Step Away, was
      developed. Step Away usage data indicate that user engagement with modules that are not
      "pushed" to the user is relatively low, which is a problem that many health apps experience.
      A new method of delivering Step Away through an artificially intelligent (AI) chatbot will be
      developed that holds potential for providing enhanced user engagement and effectiveness as it
      can reach out through a text interface to introduce new intervention steps and respond to the
      user with Step Away's in-the-moment help with having a craving, experiencing distress or
      needing social support. The first phase of this study will focus on developing a Step Away
      chatbot and enhance the existing Step Away app's user interface. The second phase will entail
      a pilot study to determine if the Step Away chatbot has enhanced user engagement,
      intervention fidelity and outcome efficacy in comparison to the Step Away app amongst a group
      of problem drinkers. Participants will be interviewed to determine their perceptions of both
      interventions with a view towards understanding barriers to user engagement. Finally, this
      project will set the stage for a further, large-scale evaluation of Step Away, the content of
      which will be determined by the outcome of the pilot study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Alcohol Consumption (Drinks Per Day)
time frame: Baseline and 16 weeks
description: The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.
measure: Change in Alcohol-Related Problems
time frame: Baseline and 16 weeks
description: The Short Inventory of Problems - Revised (SIP-R) is a self-report inventory of adverse consequences associated with drug and alcohol use. It is comprised of 17 questions scored on a 4-point Likert scale from 1 (never) to 4 (daily or almost daily). Item responses are summed to produce a total score and five subscale scores (physical, intrapersonal, social responsibility, interpersonal, and impulse control). Higher scores indicate more life problems related to alcohol use. In populations of problem drinkers, the SIP-R has demonstrated good concurrent validity and internal consistency. The SIP-R will be administered at baseline and follow-up to examine between group changes over time. Scale ranges from 17 to 68.
measure: Change in Alcohol Consumption (Heavy Drinking Days)
time frame: Baseline and 16 weeks
description: The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.
measure: Change in Alcohol Consumption (Percentage of Days Abstinent)
time frame: Baseline and 16 weeks
description: The Timeline Followback (TLFB) will be used to gather information on alcohol and drug use. The TLFB method has demonstrated good test-retest reliability and high correlations with prospective daily recording methods for quantifying alcohol use. In the current study, a 30-day online version will be administered at baseline and the 4 month post-intervention follow-up assessment. Online versions of the TLFB have been shown to have high correlations with phone and in-person interviewer administered versions of the TLFB The TLFB will be used to calculate the following drinking variables: average (mean) drinks per week, days abstinent, and heavy drinking days. Heavy drinking days will be defined as days with 4 or more standard drinks for women and 5 or more standard drinks for men.
measure: Change in Readiness to Change
time frame: Baseline and 16 weeks
description: Given that the main underlying theoretical framework of Step Away is motivational enhancement (ME), we want to examine readiness to change as a mediating variable. We will utilize the Readiness to Change Treatment Version (RCQTV) in this study to assess this construct. The RCQTV has been shown to have solid reliability and validity and has been modified for individuals contemplating or engaged in treatment for alcohol problems. Scale ranges from -8 to 8; higher scores represent higher motivation to change.
measure: Intervention Utilization Data
time frame: 16 weeks
description: Intervention utilization data is used to calculate how frequently participants used the app or the chatbot during the study period. Means and standard deviations will be used to calculate this measure. Unit of measure is the number of times a user clicked on the app or the chabot during the study period.
measure: Qualitative Perceptions of Step Away App and Chatbot
time frame: 16 weeks
description: Retrospective qualitative interviews conducted with 10 chatbot and 10 app users to understand how they used technology and their recommendations for improving the experience. Semi-structured interviews were conducted with participants who had completed follow-up assessments. Participants were purposefully selected to maximize variation in the app (n=10) or the chatbot (n=10) usage. Eleven core interview questions were asked of both app and chatbot users, plus an additional chatbot user question about their experience with and impressions of the chatbot's conversational quality. A random number generator was used to select the 5 high users and 5 low users of each intervention. Qualitative analysis software was used to identify themes related to perceived helpfulness, barriers, motivators, and improvements; key themes related to these topics are reported here. No quantitative data were collected during the interviews.
arm group label: Step Away App
arm group type: Active Comparator
description: Participants randomly assigned to this arm will access the Step Away smartphone-based mobile application immediately upon enrollment.
arm group label: Step Away Chatbot
arm group type: Experimental
description: Participants randomly assigned to this arm will access the Step Away mobile, text-based, interactive AI chatbot immediately upon enrollment.
arm group label: Step Away App Delay
arm group type: No Intervention
description: Participants randomly assigned to this arm will be provided access to the Step Away smartphone-based mobile application three months after enrollment.
intervention type: Behavioral
intervention name: Step Away Chatbot
description: The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.
The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.
arm group label: Step Away Chatbot
intervention type: Behavioral
intervention name: Step Away App
description: The Step Away app is a smartphone-based mobile intervention system.
It is informed by three theoretical constructs that are considered the most important "active ingredients" for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies.
arm group label: Step Away App
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick Dulin, PhD
role: Principal Investigator
affiliation: University of Alaska Anchorage
facility: 
country: United States
citation: Dulin PL, Gonzalez VM, Campbell K. Results of a pilot test of a self-administered smartphone-based treatment system for alcohol use disorders: usability and early outcomes. Subst Abus. 2014;35(2):168-75. doi: 10.1080/08897077.2013.821437.
PMID: 24821354
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Alcohol Drinking
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 