<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/NCT03027466</url>
  </required_header>
  <id_info>
    <org_study_id>999917039</org_study_id>
    <secondary_id>17-C-N039</secondary_id>
    <nct_id>NCT03027466</nct_id>
  </id_info>
  <brief_title>Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging</brief_title>
  <official_title>Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as&#xD;
      a threat if they think it suggests that they are unable to meet the challenges of stopping.&#xD;
      When people feel such a threat to their sense of self-identity, they may get defensive. They&#xD;
      may want to downplay the importance of quitting. This could make them try to quit less.&#xD;
      Self-affirmation is a process of focusing on strengths and values. This can offset threats to&#xD;
      the self and promote healthier behavior.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To explore people s values, smoking attitudes, and smoking behavior.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People ages 18 and older who smoke&#xD;
&#xD;
      Design:&#xD;
&#xD;
      The study takes place entirely on a mobile device.&#xD;
&#xD;
      Participants will give their age, gender, data about their smoking habits, and desired quit&#xD;
      date.&#xD;
&#xD;
      Then they will get different texts about quitting.&#xD;
&#xD;
      Participants will answer follow-up surveys 1 and 3 months later.&#xD;
&#xD;
      ...&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Quitting smoking is challenging and relapse is likely. Smokers may perceive temptation to&#xD;
      smoke as threatening if they think it suggests that they are unable to meet the challenges of&#xD;
      cessation. When individuals experience such a threat to their sense of self-identity (e.g.,&#xD;
      to their sense that they have integrity and/ or competence), they often respond defensively.&#xD;
      Individuals have a tendency to react defensively to information that informs them that their&#xD;
      behavior increases risk for a particular disease or negative health consequences.&#xD;
      Self-affirmation a process through which individuals focus on their strengths and values can&#xD;
      offset threats to the self and promote healthier behaviors, including smoking cessation. To&#xD;
      the extent that relapse or difficulty quitting is perceived as a threat to self-identity,&#xD;
      when individuals are presented with the opportunity to self-affirm they may perceive failure&#xD;
      as less threatening, mitigating the motivation to downplay the importance of quitting.&#xD;
      Preliminary evidence suggests that self-affirmation can be feasibly incorporated into an&#xD;
      existing smoking cessation text message-based intervention, and may bolster cessation rates&#xD;
      among users motivated to quit smoking. Here, we propose to extend that research by examining&#xD;
      whether the addition of self-affirmation text messages to a smoking cessation app (Smoke Free&#xD;
      United Kingdom (UK) promotes smoking cessation, compared to standard of care (i.e., existing&#xD;
      app content only). Importantly, self-affirmation material will be incorporated into the&#xD;
      current app and will not change the goals or nature of the original texting program. We&#xD;
      predict that the individuals in the self-affirmation condition will be more likely to report&#xD;
      being smoke-free at the 1-month and 3-month follow-ups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2018</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months</measure>
    <time_frame>1 month and 3 months</time_frame>
    <description>Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up</measure>
    <time_frame>1 month and 3 months follow-up</time_frame>
    <description>Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of Tobacco Products</measure>
    <time_frame>1 month and 3 months follow-up</time_frame>
    <description>Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">7899</enrollment>
  <condition>Number of Quit Attempts</condition>
  <arm_group>
    <arm_group_label>Baseline Affirmation and Affirmation Texts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study and will receive affirmation text messages throughout the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baseline Affirmation and No Affirmation Texts</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study but will not receive affirmation text messages throughout the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Baseline Affirmation and Affirmation Texts</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will not be given a &quot;Baseline Affirmation Quiz&quot; but will receive affirmation text messages throughout the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Baseline Affirmation and No Affirmation Texts</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-affirmation induction</intervention_name>
    <description>Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
    <arm_group_label>Baseline Affirmation and Affirmation Texts</arm_group_label>
    <arm_group_label>Baseline Affirmation and No Affirmation Texts</arm_group_label>
    <arm_group_label>No Baseline Affirmation and Affirmation Texts</arm_group_label>
    <arm_group_label>No Baseline Affirmation and No Affirmation Texts</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION/EXCLUSION:&#xD;
&#xD;
          -  Because the app is designed to assist with smoking cessation, all smokers are eligible&#xD;
             to participate.&#xD;
&#xD;
          -  Subjects are eligible if they are 18+ years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William M Klein, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cancer Institute (NCI)</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Armitage CJ, Harris PR, Hepton G, Napper L. Self-affirmation increases acceptance of health-risk information among UK adult smokers with low socioeconomic status. Psychol Addict Behav. 2008 Mar;22(1):88-95. doi: 10.1037/0893-164X.22.1.88.</citation>
    <PMID>18298234</PMID>
  </reference>
  <reference>
    <citation>Spohr SA, Nandy R, Gandhiraj D, Vemulapalli A, Anne S, Walters ST. Efficacy of SMS Text Message Interventions for Smoking Cessation: A Meta-Analysis. J Subst Abuse Treat. 2015 Sep;56:1-10. doi: 10.1016/j.jsat.2015.01.011. Epub 2015 Feb 2.</citation>
    <PMID>25720333</PMID>
  </reference>
  <reference>
    <citation>Cohen GL, Garcia J, Purdie-Vaughns V, Apfel N, Brzustoski P. Recursive processes in self-affirmation: intervening to close the minority achievement gap. Science. 2009 Apr 17;324(5925):400-3. doi: 10.1126/science.1170769.</citation>
    <PMID>19372432</PMID>
  </reference>
  <results_reference>
    <citation>Seaman EL, Robinson CD, Crane D, Taber JM, Ferrer RA, Harris PR, Klein WMP. Association of Spontaneous and Induced Self-Affirmation With Smoking Cessation in Users of a Mobile App: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 5;23(3):e18433. doi: 10.2196/18433.</citation>
    <PMID>33666561</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>April 16, 2021</results_first_submitted>
  <results_first_submitted_qc>July 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 23, 2021</results_first_posted>
  <last_update_submitted>July 22, 2021</last_update_submitted>
  <last_update_submitted_qc>July 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Institute (NCI)</investigator_affiliation>
    <investigator_full_name>William Klein, Ph.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Quitting Smoking</keyword>
  <keyword>Phone Application</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>September 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03027466/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Baseline Affirmation and Affirmation Texts</title>
          <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study and will receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition).Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
        </group>
        <group group_id="P2">
          <title>Baseline Affirmation and No Affirmation Texts</title>
          <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study but will not receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
        </group>
        <group group_id="P3">
          <title>No Baseline Affirmation and Affirmation Texts</title>
          <description>Participants will not be given a &quot;Baseline Affirmation Quiz&quot; but will receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
        </group>
        <group group_id="P4">
          <title>No Baseline Affirmation and No Affirmation Texts</title>
          <description>Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2027"/>
                <participants group_id="P2" count="1984"/>
                <participants group_id="P3" count="1903"/>
                <participants group_id="P4" count="1985"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="158"/>
                <participants group_id="P2" count="165"/>
                <participants group_id="P3" count="160"/>
                <participants group_id="P4" count="164"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1869"/>
                <participants group_id="P2" count="1819"/>
                <participants group_id="P3" count="1743"/>
                <participants group_id="P4" count="1821"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Opting out of the app</title>
              <participants_list>
                <participants group_id="P1" count="1869"/>
                <participants group_id="P2" count="1819"/>
                <participants group_id="P3" count="1743"/>
                <participants group_id="P4" count="1821"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Baseline Affirmation and Affirmation Texts</title>
          <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study and will receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
        </group>
        <group group_id="B2">
          <title>Baseline Affirmation and No Affirmation Texts</title>
          <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study but will not receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
        </group>
        <group group_id="B3">
          <title>No Baseline Affirmation and Affirmation Texts</title>
          <description>Participants will not be given a &quot;Baseline Affirmation Quiz&quot; but will receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
        </group>
        <group group_id="B4">
          <title>No Baseline Affirmation and No Affirmation Texts</title>
          <description>Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
        </group>
        <group group_id="B5">
          <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="2027"/>
            <count group_id="B2" value="1984"/>
            <count group_id="B3" value="1903"/>
            <count group_id="B4" value="1985"/>
            <count group_id="B5" value="7899"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2027"/>
                    <count group_id="B2" value="1984"/>
                    <count group_id="B3" value="1903"/>
                    <count group_id="B4" value="1985"/>
                    <count group_id="B5" value="7899"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2027"/>
                    <measurement group_id="B2" value="1984"/>
                    <measurement group_id="B3" value="1903"/>
                    <measurement group_id="B4" value="1985"/>
                    <measurement group_id="B5" value="7899"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2027"/>
                    <count group_id="B2" value="1984"/>
                    <count group_id="B3" value="1903"/>
                    <count group_id="B4" value="1985"/>
                    <count group_id="B5" value="7899"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.6" spread="8.6"/>
                    <measurement group_id="B2" value="30.5" spread="8.6"/>
                    <measurement group_id="B3" value="30.5" spread="8.8"/>
                    <measurement group_id="B4" value="30.5" spread="8.7"/>
                    <measurement group_id="B5" value="30.5" spread="8.7"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2027"/>
                    <count group_id="B2" value="1984"/>
                    <count group_id="B3" value="1903"/>
                    <count group_id="B4" value="1985"/>
                    <count group_id="B5" value="7899"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="799"/>
                    <measurement group_id="B2" value="759"/>
                    <measurement group_id="B3" value="765"/>
                    <measurement group_id="B4" value="786"/>
                    <measurement group_id="B5" value="3109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1228"/>
                    <measurement group_id="B2" value="1225"/>
                    <measurement group_id="B3" value="1138"/>
                    <measurement group_id="B4" value="1199"/>
                    <measurement group_id="B5" value="4790"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2027"/>
                    <count group_id="B2" value="1984"/>
                    <count group_id="B3" value="1903"/>
                    <count group_id="B4" value="1985"/>
                    <count group_id="B5" value="7899"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2027"/>
                    <measurement group_id="B2" value="1984"/>
                    <measurement group_id="B3" value="1903"/>
                    <measurement group_id="B4" value="1985"/>
                    <measurement group_id="B5" value="7899"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants Currently Using Cessation Aid</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2027"/>
                    <count group_id="B2" value="1984"/>
                    <count group_id="B3" value="1903"/>
                    <count group_id="B4" value="1985"/>
                    <count group_id="B5" value="7899"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="446"/>
                    <measurement group_id="B2" value="401"/>
                    <measurement group_id="B3" value="434"/>
                    <measurement group_id="B4" value="440"/>
                    <measurement group_id="B5" value="1721"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2027"/>
                    <count group_id="B2" value="1984"/>
                    <count group_id="B3" value="1903"/>
                    <count group_id="B4" value="1985"/>
                    <count group_id="B5" value="7899"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1581"/>
                    <measurement group_id="B2" value="1583"/>
                    <measurement group_id="B3" value="1469"/>
                    <measurement group_id="B4" value="1545"/>
                    <measurement group_id="B5" value="6178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Desire to Smoke</title>
          <description>Desire to smoke: 1 = not at all; 5 = a lot.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2027"/>
                    <count group_id="B2" value="1984"/>
                    <count group_id="B3" value="1903"/>
                    <count group_id="B4" value="1985"/>
                    <count group_id="B5" value="7899"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.2" spread="1.3"/>
                    <measurement group_id="B2" value="3.1" spread="1.4"/>
                    <measurement group_id="B3" value="3.2" spread="1.3"/>
                    <measurement group_id="B4" value="3.1" spread="1.4"/>
                    <measurement group_id="B5" value="3.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Quit Attempts in Past Year</title>
          <description>Past year cessation attempts were assessed as a write-in question; all values from 0 to 365 were considered valid cases. All responses outside of this range were excluded from analysis of past year cessation attempts but were included in all subsequent analyses.</description>
          <units>Attempts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2027"/>
                    <count group_id="B2" value="1984"/>
                    <count group_id="B3" value="1903"/>
                    <count group_id="B4" value="1985"/>
                    <count group_id="B5" value="7899"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.2" spread="22.8"/>
                    <measurement group_id="B2" value="6.5" spread="20.7"/>
                    <measurement group_id="B3" value="6.6" spread="19.6"/>
                    <measurement group_id="B4" value="7.9" spread="27.5"/>
                    <measurement group_id="B5" value="7.9" spread="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months</title>
        <description>Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.</description>
        <time_frame>1 month and 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Baseline Affirmation and Affirmation Texts</title>
            <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study and will receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
          </group>
          <group group_id="O2">
            <title>Baseline Affirmation and No Affirmation Texts</title>
            <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study but will not receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
          </group>
          <group group_id="O3">
            <title>No Baseline Affirmation and Affirmation Texts</title>
            <description>Participants will not be given a &quot;Baseline Affirmation Quiz&quot; but will receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
          </group>
          <group group_id="O4">
            <title>No Baseline Affirmation and No Affirmation Texts</title>
            <description>Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months</title>
          <description>Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2027"/>
                <count group_id="O2" value="1984"/>
                <count group_id="O3" value="1903"/>
                <count group_id="O4" value="1985"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Past Week Cessation at 1 Month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="139"/>
                    <measurement group_id="O4" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Past Month Cessation at 1 Month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="128"/>
                    <measurement group_id="O3" value="128"/>
                    <measurement group_id="O4" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Past Week Cessation at 3 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="58"/>
                    <measurement group_id="O3" value="55"/>
                    <measurement group_id="O4" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Past Month Cessation at 3 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="48"/>
                    <measurement group_id="O4" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up</title>
        <description>Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.</description>
        <time_frame>1 month and 3 months follow-up</time_frame>
        <population>This outcome measure was not done because there was too little variability, and the data could not be analyzed due to high levels of attrition. The former Principal Investigator left the institute and no data are available or will ever become available for this Outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline Affirmation and Affirmation Texts</title>
            <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study and will receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
          </group>
          <group group_id="O2">
            <title>Baseline Affirmation and No Affirmation Texts</title>
            <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study but will not receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
          </group>
          <group group_id="O3">
            <title>No Baseline Affirmation and Affirmation Texts</title>
            <description>Participants will not be given a &quot;Baseline Affirmation Quiz&quot; but will receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
          </group>
          <group group_id="O4">
            <title>No Baseline Affirmation and No Affirmation Texts</title>
            <description>Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up</title>
          <description>Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.</description>
          <population>This outcome measure was not done because there was too little variability, and the data could not be analyzed due to high levels of attrition. The former Principal Investigator left the institute and no data are available or will ever become available for this Outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Type of Tobacco Products</title>
        <description>Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.</description>
        <time_frame>1 month and 3 months follow-up</time_frame>
        <population>This outcome measure was not done because type of tobacco products were not collected from participants at 1 month and 3 months follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline Affirmation and Affirmation Texts</title>
            <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study and will receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
          </group>
          <group group_id="O2">
            <title>Baseline Affirmation and No Affirmation Texts</title>
            <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study but will not receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
          </group>
          <group group_id="O3">
            <title>No Baseline Affirmation and Affirmation Texts</title>
            <description>Participants will not be given a &quot;Baseline Affirmation Quiz&quot; but will receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
          </group>
          <group group_id="O4">
            <title>No Baseline Affirmation and No Affirmation Texts</title>
            <description>Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
          </group>
        </group_list>
        <measure>
          <title>Type of Tobacco Products</title>
          <description>Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.</description>
          <population>This outcome measure was not done because type of tobacco products were not collected from participants at 1 month and 3 months follow-up.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Study start to study completion date, approximately 17 months and 26 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Baseline Affirmation and Affirmation Texts</title>
          <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study and will receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
        </group>
        <group group_id="E2">
          <title>Baseline Affirmation and No Affirmation Texts</title>
          <description>Participants will be given a &quot;Baseline Affirmation&quot; Quiz at the beginning of the study but will not receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
        </group>
        <group group_id="E3">
          <title>No Baseline Affirmation and Affirmation Texts</title>
          <description>Participants will not be given a &quot;Baseline Affirmation Quiz&quot; but will receive affirmation text messages throughout the study&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</description>
        </group>
        <group group_id="E4">
          <title>No Baseline Affirmation and No Affirmation Texts</title>
          <description>Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)&#xD;
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.</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="2027"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1984"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1903"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1985"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2027"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1984"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1903"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1985"/>
              </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="2027"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1984"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1903"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1985"/>
              </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>William Klein</name_or_title>
      <organization>National Cancer Institute</organization>
      <phone>2402766972</phone>
      <email>kleinwm@mail.nih.gov</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/NCT03027466
org study id: 999917039
secondary id: 17-C-N039
nct id: NCT03027466
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background:

      Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as
      a threat if they think it suggests that they are unable to meet the challenges of stopping.
      When people feel such a threat to their sense of self-identity, they may get defensive. They
      may want to downplay the importance of quitting. This could make them try to quit less.
      Self-affirmation is a process of focusing on strengths and values. This can offset threats to
      the self and promote healthier behavior.

      Objective:

      To explore people s values, smoking attitudes, and smoking behavior.

      Eligibility:

      People ages 18 and older who smoke

      Design:

      The study takes place entirely on a mobile device.

      Participants will give their age, gender, data about their smoking habits, and desired quit
      date.

      Then they will get different texts about quitting.

      Participants will answer follow-up surveys 1 and 3 months later.

      ...
Quitting smoking is challenging and relapse is likely. Smokers may perceive temptation to
      smoke as threatening if they think it suggests that they are unable to meet the challenges of
      cessation. When individuals experience such a threat to their sense of self-identity (e.g.,
      to their sense that they have integrity and/ or competence), they often respond defensively.
      Individuals have a tendency to react defensively to information that informs them that their
      behavior increases risk for a particular disease or negative health consequences.
      Self-affirmation a process through which individuals focus on their strengths and values can
      offset threats to the self and promote healthier behaviors, including smoking cessation. To
      the extent that relapse or difficulty quitting is perceived as a threat to self-identity,
      when individuals are presented with the opportunity to self-affirm they may perceive failure
      as less threatening, mitigating the motivation to downplay the importance of quitting.
      Preliminary evidence suggests that self-affirmation can be feasibly incorporated into an
      existing smoking cessation text message-based intervention, and may bolster cessation rates
      among users motivated to quit smoking. Here, we propose to extend that research by examining
      whether the addition of self-affirmation text messages to a smoking cessation app (Smoke Free
      United Kingdom (UK) promotes smoking cessation, compared to standard of care (i.e., existing
      app content only). Importantly, self-affirmation material will be incorporated into the
      current app and will not change the goals or nature of the original texting program. We
      predict that the individuals in the self-affirmation condition will be more likely to report
      being smoke-free at the 1-month and 3-month follow-ups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
time frame: 1 month and 3 months
description: Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.
measure: Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up
time frame: 1 month and 3 months follow-up
description: Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.
measure: Type of Tobacco Products
time frame: 1 month and 3 months follow-up
description: Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.
arm group label: Baseline Affirmation and Affirmation Texts
arm group type: Experimental
description: Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study
arm group label: Baseline Affirmation and No Affirmation Texts
arm group type: Active Comparator
description: Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study
arm group label: No Baseline Affirmation and Affirmation Texts
arm group type: Active Comparator
description: Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study
arm group label: No Baseline Affirmation and No Affirmation Texts
arm group type: Placebo Comparator
description: Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)
intervention type: Behavioral
intervention name: Self-affirmation induction
description: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
arm group label: Baseline Affirmation and Affirmation Texts
arm group label: Baseline Affirmation and No Affirmation Texts
arm group label: No Baseline Affirmation and Affirmation Texts
arm group label: No Baseline Affirmation and No Affirmation Texts
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: William M Klein, Ph.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
citation: Armitage CJ, Harris PR, Hepton G, Napper L. Self-affirmation increases acceptance of health-risk information among UK adult smokers with low socioeconomic status. Psychol Addict Behav. 2008 Mar;22(1):88-95. doi: 10.1037/0893-164X.22.1.88.
PMID: 18298234
citation: Spohr SA, Nandy R, Gandhiraj D, Vemulapalli A, Anne S, Walters ST. Efficacy of SMS Text Message Interventions for Smoking Cessation: A Meta-Analysis. J Subst Abuse Treat. 2015 Sep;56:1-10. doi: 10.1016/j.jsat.2015.01.011. Epub 2015 Feb 2.
PMID: 25720333
citation: Cohen GL, Garcia J, Purdie-Vaughns V, Apfel N, Brzustoski P. Recursive processes in self-affirmation: intervening to close the minority achievement gap. Science. 2009 Apr 17;324(5925):400-3. doi: 10.1126/science.1170769.
PMID: 19372432
citation: Seaman EL, Robinson CD, Crane D, Taber JM, Ferrer RA, Harris PR, Klein WMP. Association of Spontaneous and Induced Self-Affirmation With Smoking Cessation in Users of a Mobile App: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 5;23(3):e18433. doi: 10.2196/18433.
PMID: 33666561
responsible party type: Principal Investigator
investigator affiliation: National Cancer Institute (NCI)
investigator full name: William Klein, Ph.D.
investigator title: Principal Investigator
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 