<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/NCT02997657</url>
  </required_header>
  <id_info>
    <org_study_id>R01CA201262</org_study_id>
    <nct_id>NCT02997657</nct_id>
  </id_info>
  <brief_title>Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial</brief_title>
  <official_title>Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Truth Initiative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Positive Psychotherapy for Smoking Cessation (PPT-S) addresses an array of risk factors for&#xD;
      poor smoking outcomes (low positive affect, depressive symptoms, and cynical cognitions),&#xD;
      while also providing skills that may buffer against stress and negative affect. The overall&#xD;
      objective of this project is to conduct a randomized controlled trial to test the efficacy of&#xD;
      PPT-S, enhanced with text messaging, compared to a time-matched behavioral smoking cessation&#xD;
      treatment. Participants in both treatment conditions will receive nicotine replacement&#xD;
      therapy and a validated text-messaging intervention for smoking cessation that monitors&#xD;
      progress in quitting smoking and extends smoking counseling outside of the individual&#xD;
      face-to-face context.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">November 15, 2021</completion_date>
  <primary_completion_date type="Actual">November 15, 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>7-day Point Prevalence Smoking Abstinence at 12 Weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Self-reported smoking abstinence biochemically confirmed with CO and cotinine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>7-day Point Prevalence Smoking Abstinence at 26 Weeks</measure>
    <time_frame>26 weeks</time_frame>
    <description>Self-reported smoking abstinence biochemically confirmed with CO and cotinine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>7-day Point Prevalence Smoking Abstinence at 52 Weeks</measure>
    <time_frame>52 weeks</time_frame>
    <description>Self-reported smoking abstinence biochemically confirmed with CO and cotinine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Continuous Smoking Abstinence</measure>
    <time_frame>52 weeks</time_frame>
    <description>Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Engagement in PPT-consistent Quitting Strategies</measure>
    <time_frame>During treatment - weeks 1-4 after quit date</time_frame>
    <description>Engaging in strategies consistent with the positive psychology exercises taught in the trial. Nine strategies are assessed on 1 to 5 scale with 5 reflecting greater use of the strategies. The total score is the average across the 9 item.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual Attraction to Smoking</measure>
    <time_frame>At end of treatment (4 weeks after quit date)</time_frame>
    <description>Self-report residual attraction to smoking. Three questions are dichotomized and any positive response indicating residual attraction to smoking is coded as a 1 with any having only negative responses is coded as 0 - no residual attraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy for Resisting Smoking</measure>
    <time_frame>At end of treatment (4 weeks after quit date)</time_frame>
    <description>Self-reported confidence in remaining abstinent from smoking. The 9-item scale uses a 1-5 response scale and the total score is the average of those 9 responses, where higher scores represent higher confidence in resisting smoking.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">271</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Positive Psychotherapy for Smoking Cessation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard smoking cessation treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive Psychotherapy</intervention_name>
    <description>Exercises designed to boost moods, positive behaviors, and positive cognitions.</description>
    <arm_group_label>Positive Psychotherapy for Smoking Cessation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard smoking cessation counseling</intervention_name>
    <description>Counseling designed to provide support and problem solving for smoking cessation</description>
    <arm_group_label>Positive Psychotherapy for Smoking Cessation</arm_group_label>
    <arm_group_label>Standard smoking cessation treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. be 18 years of age or older&#xD;
&#xD;
          2. smoke at least 5 cigarettes per day for longer than one year with no current regular&#xD;
             use of other nicotine/tobacco products including e-cigarettes&#xD;
&#xD;
          3. have a baseline carbon monoxide level of at least 4 ppm&#xD;
&#xD;
          4. be willing to use the nicotine patch&#xD;
&#xD;
          5. report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking&#xD;
             (where 10 = extremely important);&#xD;
&#xD;
          6. have an active cell phone and be willing to send and receive text messages for the&#xD;
             duration of the intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Contact study site for details&#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>Christopher Kahler, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Partners Healthcare and Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Alcohol and Addiction Studies, Brown University</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <results_first_submitted>December 22, 2022</results_first_submitted>
  <results_first_submitted_qc>February 6, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 1, 2023</results_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brown University</investigator_affiliation>
    <investigator_full_name>Christopher W. Kahler</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 22, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT02997657/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 22, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT02997657/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Positive Psychotherapy for Smoking Cessation</title>
          <description>Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.&#xD;
Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
        </group>
        <group group_id="P2">
          <title>Standard Smoking Cessation Treatment</title>
          <description>Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
                <participants group_id="P2" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Positive Psychotherapy for Smoking Cessation</title>
          <description>Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.&#xD;
Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
        </group>
        <group group_id="B2">
          <title>Standard Smoking Cessation Treatment</title>
          <description>Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="140"/>
            <count group_id="B2" value="131"/>
            <count group_id="B3" value="271"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="140"/>
                    <count group_id="B2" value="131"/>
                    <count group_id="B3" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.2" spread="12.1"/>
                    <measurement group_id="B2" value="49.2" spread="12.0"/>
                    <measurement group_id="B3" value="49.2" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Self reported sex missing for one 1 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="140"/>
                    <count group_id="B2" value="130"/>
                    <count group_id="B3" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="131"/>
                    <count group_id="B3" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="132"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="255"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="131"/>
                    <count group_id="B3" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="230"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fagerstrom test for cigarette dependence</title>
          <description>Self report measure of cigarette dependence with scores ranging from 0 to 10, where 10 is the highest level of dependence.</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="140"/>
                    <count group_id="B2" value="131"/>
                    <count group_id="B3" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.1" spread="2.0"/>
                    <measurement group_id="B2" value="4.5" spread="2.1"/>
                    <measurement group_id="B3" value="4.8" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CES-D Total Score</title>
          <description>Center for Epidemiologic Studies-Depression Scale, total score. This 20-item scale has total scores ranging from 0-60 with higher scores indicating more severe depresssive symptoms. A score of 16 of greater is typically used to indicate possible major depressive disorder.</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="140"/>
                    <count group_id="B2" value="131"/>
                    <count group_id="B3" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.1" spread="10.0"/>
                    <measurement group_id="B2" value="12.1" spread="9.5"/>
                    <measurement group_id="B3" value="12.6" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>7-day Point Prevalence Smoking Abstinence at 12 Weeks</title>
        <description>Self-reported smoking abstinence biochemically confirmed with CO and cotinine</description>
        <time_frame>12 weeks</time_frame>
        <population>1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Psychotherapy for Smoking Cessation</title>
            <description>Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.&#xD;
Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard Smoking Cessation Treatment</title>
            <description>Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>7-day Point Prevalence Smoking Abstinence at 12 Weeks</title>
          <description>Self-reported smoking abstinence biochemically confirmed with CO and cotinine</description>
          <population>1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses.</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="139"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.71</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>7-day Point Prevalence Smoking Abstinence at 26 Weeks</title>
        <description>Self-reported smoking abstinence biochemically confirmed with CO and cotinine</description>
        <time_frame>26 weeks</time_frame>
        <population>1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Psychotherapy for Smoking Cessation</title>
            <description>Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.&#xD;
Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard Smoking Cessation Treatment</title>
            <description>Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>7-day Point Prevalence Smoking Abstinence at 26 Weeks</title>
          <description>Self-reported smoking abstinence biochemically confirmed with CO and cotinine</description>
          <population>1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses.</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="139"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.81</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>7-day Point Prevalence Smoking Abstinence at 52 Weeks</title>
        <description>Self-reported smoking abstinence biochemically confirmed with CO and cotinine</description>
        <time_frame>52 weeks</time_frame>
        <population>1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Psychotherapy for Smoking Cessation</title>
            <description>Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.&#xD;
Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard Smoking Cessation Treatment</title>
            <description>Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>7-day Point Prevalence Smoking Abstinence at 52 Weeks</title>
          <description>Self-reported smoking abstinence biochemically confirmed with CO and cotinine</description>
          <population>1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses.</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="139"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.69</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Continuous Smoking Abstinence</title>
        <description>Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks</description>
        <time_frame>52 weeks</time_frame>
        <population>1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Psychotherapy for Smoking Cessation</title>
            <description>Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.&#xD;
Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard Smoking Cessation Treatment</title>
            <description>Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Continuous Smoking Abstinence</title>
          <description>Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks</description>
          <population>1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses.</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="139"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.96</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Engagement in PPT-consistent Quitting Strategies</title>
        <description>Engaging in strategies consistent with the positive psychology exercises taught in the trial. Nine strategies are assessed on 1 to 5 scale with 5 reflecting greater use of the strategies. The total score is the average across the 9 item.</description>
        <time_frame>During treatment - weeks 1-4 after quit date</time_frame>
        <population>Participants were asked these questions at the final session of counseling. Therefore only participants attending that session were analyzed. One participant in the Positive Psychotherapy condition completed the final session but did not complete this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Psychotherapy for Smoking Cessation</title>
            <description>Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.&#xD;
Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard Smoking Cessation Treatment</title>
            <description>Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Engagement in PPT-consistent Quitting Strategies</title>
          <description>Engaging in strategies consistent with the positive psychology exercises taught in the trial. Nine strategies are assessed on 1 to 5 scale with 5 reflecting greater use of the strategies. The total score is the average across the 9 item.</description>
          <population>Participants were asked these questions at the final session of counseling. Therefore only participants attending that session were analyzed. One participant in the Positive Psychotherapy condition completed the final session but did not complete this measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.88" spread="0.82"/>
                    <measurement group_id="O2" value="4.07" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.11</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Residual Attraction to Smoking</title>
        <description>Self-report residual attraction to smoking. Three questions are dichotomized and any positive response indicating residual attraction to smoking is coded as a 1 with any having only negative responses is coded as 0 - no residual attraction.</description>
        <time_frame>At end of treatment (4 weeks after quit date)</time_frame>
        <population>Participants were asked these questions at the final session of counseling. Therefore only participants attending that session were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Psychotherapy for Smoking Cessation</title>
            <description>Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.&#xD;
Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard Smoking Cessation Treatment</title>
            <description>Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Residual Attraction to Smoking</title>
          <description>Self-report residual attraction to smoking. Three questions are dichotomized and any positive response indicating residual attraction to smoking is coded as a 1 with any having only negative responses is coded as 0 - no residual attraction.</description>
          <population>Participants were asked these questions at the final session of counseling. Therefore only participants attending that session were analyzed.</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="88"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.90</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-efficacy for Resisting Smoking</title>
        <description>Self-reported confidence in remaining abstinent from smoking. The 9-item scale uses a 1-5 response scale and the total score is the average of those 9 responses, where higher scores represent higher confidence in resisting smoking.</description>
        <time_frame>At end of treatment (4 weeks after quit date)</time_frame>
        <population>Participants were asked these questions at the final session of counseling. Therefore only participants attending that session were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Psychotherapy for Smoking Cessation</title>
            <description>Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.&#xD;
Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard Smoking Cessation Treatment</title>
            <description>Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy for Resisting Smoking</title>
          <description>Self-reported confidence in remaining abstinent from smoking. The 9-item scale uses a 1-5 response scale and the total score is the average of those 9 responses, where higher scores represent higher confidence in resisting smoking.</description>
          <population>Participants were asked these questions at the final session of counseling. Therefore only participants attending that session were analyzed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.76" spread="1.12"/>
                    <measurement group_id="O2" value="3.80" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.82</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>52 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Positive Psychotherapy for Smoking Cessation</title>
          <description>Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.&#xD;
Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</description>
        </group>
        <group group_id="E2">
          <title>Standard Smoking Cessation Treatment</title>
          <description>Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.&#xD;
Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation</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="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="140"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="131"/>
              </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>Christopher Kahler</name_or_title>
      <organization>Brown University School of Public Health</organization>
      <phone>401 863-6651</phone>
      <email>christopher_kahler@brown.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/NCT02997657
org study id: R01CA201262
nct id: NCT02997657
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Positive Psychotherapy for Smoking Cessation (PPT-S) addresses an array of risk factors for
      poor smoking outcomes (low positive affect, depressive symptoms, and cynical cognitions),
      while also providing skills that may buffer against stress and negative affect. The overall
      objective of this project is to conduct a randomized controlled trial to test the efficacy of
      PPT-S, enhanced with text messaging, compared to a time-matched behavioral smoking cessation
      treatment. Participants in both treatment conditions will receive nicotine replacement
      therapy and a validated text-messaging intervention for smoking cessation that monitors
      progress in quitting smoking and extends smoking counseling outside of the individual
      face-to-face context.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 7-day Point Prevalence Smoking Abstinence at 12 Weeks
time frame: 12 weeks
description: Self-reported smoking abstinence biochemically confirmed with CO and cotinine
measure: 7-day Point Prevalence Smoking Abstinence at 26 Weeks
time frame: 26 weeks
description: Self-reported smoking abstinence biochemically confirmed with CO and cotinine
measure: 7-day Point Prevalence Smoking Abstinence at 52 Weeks
time frame: 52 weeks
description: Self-reported smoking abstinence biochemically confirmed with CO and cotinine
measure: Continuous Smoking Abstinence
time frame: 52 weeks
description: Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks
measure: Engagement in PPT-consistent Quitting Strategies
time frame: During treatment - weeks 1-4 after quit date
description: Engaging in strategies consistent with the positive psychology exercises taught in the trial. Nine strategies are assessed on 1 to 5 scale with 5 reflecting greater use of the strategies. The total score is the average across the 9 item.
measure: Residual Attraction to Smoking
time frame: At end of treatment (4 weeks after quit date)
description: Self-report residual attraction to smoking. Three questions are dichotomized and any positive response indicating residual attraction to smoking is coded as a 1 with any having only negative responses is coded as 0 - no residual attraction.
measure: Self-efficacy for Resisting Smoking
time frame: At end of treatment (4 weeks after quit date)
description: Self-reported confidence in remaining abstinent from smoking. The 9-item scale uses a 1-5 response scale and the total score is the average of those 9 responses, where higher scores represent higher confidence in resisting smoking.
arm group label: Positive Psychotherapy for Smoking Cessation
arm group type: Experimental
description: Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.
arm group label: Standard smoking cessation treatment
arm group type: Active Comparator
description: Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.
intervention type: Behavioral
intervention name: Positive Psychotherapy
description: Exercises designed to boost moods, positive behaviors, and positive cognitions.
arm group label: Positive Psychotherapy for Smoking Cessation
intervention type: Behavioral
intervention name: Standard smoking cessation counseling
description: Counseling designed to provide support and problem solving for smoking cessation
arm group label: Positive Psychotherapy for Smoking Cessation
arm group label: Standard smoking cessation treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christopher Kahler, PhD
role: Principal Investigator
affiliation: Brown University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brown University
investigator full name: Christopher W. Kahler
investigator title: Professor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 