<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/NCT02968381</url>
  </required_header>
  <id_info>
    <org_study_id>1R34AT008947</org_study_id>
    <secondary_id>1R34AT008947</secondary_id>
    <nct_id>NCT02968381</nct_id>
  </id_info>
  <brief_title>A Guided Imagery Tobacco Cessation Intervention Delivered by a Quit Line and Website</brief_title>
  <acronym>QLImagery</acronym>
  <official_title>A Guided Imagery Tobacco Cessation Intervention Delivered by a Quit Line and Website</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tobacco use is still the leading cause of preventable disease and death in the United States.&#xD;
      Tobacco quit lines are effective at helping smokers to quit, but quit lines are&#xD;
      underutilized, especially by men and racial/ethnic minorities. Guided imagery is effective at&#xD;
      helping people quit smoking, and is appealing to males and diverse racial groups, but has&#xD;
      limited reach. The proposed study will develop and test the feasibility and acceptability of&#xD;
      a guided imagery tobacco cessation intervention that is delivered by a combination of quit&#xD;
      line coaches and an interactive website. The investigators hypothesize that guided mental&#xD;
      imagery delivered using the quit line &quot;coaching model&quot; combined with an interactive website&#xD;
      could be an effective intervention strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this three year R34 application is to develop and test the feasibility of a&#xD;
      theory-driven, telephone plus web-based, guided mental imagery intervention for smoking&#xD;
      cessation.&#xD;
&#xD;
      Aim 1. Develop a theory-based, guided mental imagery tobacco cessation intervention for quit&#xD;
      line callers with input from expert consultants in health disparities and a Community&#xD;
      Advisory Board representing diverse populations and tobacco control stakeholders. The&#xD;
      intervention will include phone-based coaching, an interactive website, and optional&#xD;
      cessation medication. It will be focus tested with 40 smokers (from diverse racial/ethnic and&#xD;
      age groups with at least 40% males), and usability tested with 5 smokers.&#xD;
&#xD;
      Aim 2. Develop training and competency standards for, and train, four coaches in the&#xD;
      implementation of the guided imagery and control interventions. Coaches will be assessed at&#xD;
      6-weeks and 6-months post-training for implementation fidelity and satisfaction.&#xD;
&#xD;
      Aim 3. Conduct a feasibility trial (N=100) to gather preliminary data on the effects of the&#xD;
      guided mental imagery intervention on quit line callers' tobacco use, cravings, and&#xD;
      self-efficacy to quit smoking, and to refine study procedures, including recruitment,&#xD;
      retention, and use of intervention components. Participants will be randomly assigned to&#xD;
      receive either the Imagery Intervention (N=50) or an attention control condition (N=50) as&#xD;
      delivered by study coaches. Participants will be assessed at baseline, 6-weeks and 6-months&#xD;
      post-enrollment. Primary outcomes will be self-reported point prevalence and prolonged&#xD;
      abstinence of tobacco use. Biochemical validation will be conducted on a sub-sample to&#xD;
      determine validity of self-reported abstinence in this population. Secondary outcomes will be&#xD;
      self-reported cravings and self-efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">January 21, 2022</completion_date>
  <primary_completion_date type="Actual">September 29, 2020</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Change in Self-reported 7-day Tobacco Abstinence From Baseline to Follow-up</measure>
    <time_frame>6 months</time_frame>
    <description>Tobacco use over the past seven days is assessed by project staff at 6-months post-enrollment. Tobacco use includes cigarettes, smokeless tobacco, and other types of tobacco. The question is asked &quot;Have you smoked, even a puff, in the last 7 days?&quot; &quot;Have you used any other form of tobacco in the last 7 days?&quot; If yes to either question, the participant is asked to indicate what type of tobacco was used and how much was used (e.g., &quot;how many cigarettes did you smoke on a typical day?&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Change in Self-reported Tobacco 30-day Abstinence From Baseline to Follow-up</measure>
    <time_frame>6 months</time_frame>
    <description>Tobacco use over the past 30 days is assessed by project staff at 6-months post-enrollment. Tobacco use includes cigarettes, smokeless tobacco, and other types of tobacco. The question is asked &quot;Have you smoked, even a puff, in the last 30 days?&quot; &quot;Have you used any other form of tobacco in the last 30 days?&quot; If yes to either question, the participant is asked to indicate what type of tobacco was used and how much was used (e.g., &quot;how many cigarettes did you smoke on a typical day?&quot;).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Tobacco Use for Non-quitters From Baseline to Follow-up</measure>
    <time_frame>6 months</time_frame>
    <description>Assessed by project staff at 6-months post-enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-efficacy for Quitting From Baseline to Follow-up</measure>
    <time_frame>6 months</time_frame>
    <description>An abbreviated version of the Condiotte and Lichtenstein (1981) Confidence Questionnaire consisting of 5 items for quitters and 6 items for non-quitters. All items are scored using a 5-point Likert scale where 1 is low/less and 5 is high/more. We calculated an average score of the items (which would have a value between 1 and 5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Nicotine Cravings From Baseline to Follow-up</measure>
    <time_frame>6 months</time_frame>
    <description>This was assessed using 1 item adapted from the Shiffman (2004) Rating Scale (&quot;How much have you craved tobacco today?&quot;). Responses were coded using a 6-point Likert scale from &quot;not at all&quot; (code 0) to &quot;a great deal&quot; (code 5).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Tobacco Use</condition>
  <condition>Smoking Cessation</condition>
  <condition>Smoking, Tobacco</condition>
  <condition>Tobacco Smoking</condition>
  <condition>Guided Imagery</condition>
  <arm_group>
    <arm_group_label>Imagery Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Imagery Intervention</intervention_name>
    <description>Telephone coaching sessions, use of guided imagery and website.</description>
    <arm_group_label>Imagery Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control Condition</intervention_name>
    <description>Telephone coaching using standard cognitive behavioral methods</description>
    <arm_group_label>Control Condition</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current smoker trying to quit&#xD;
&#xD;
          -  Speak English&#xD;
&#xD;
          -  Internet access&#xD;
&#xD;
          -  Email access&#xD;
&#xD;
          -  Live in the state of Arizona, USA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having enrolled and participated in Quit line services in the past 12 months&#xD;
&#xD;
          -  Diagnosed with a serious mental illness (e.g. current depression)&#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>Judith Gordon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://SeeMeSmokeFree.com</url>
    <description>Pilot project using guided imagery for tobacco cessation for women concerned about weight gain</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <results_first_submitted>November 10, 2020</results_first_submitted>
  <results_first_submitted_qc>January 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 8, 2021</results_first_posted>
  <last_update_submitted>June 1, 2022</last_update_submitted>
  <last_update_submitted_qc>June 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tobacco</keyword>
  <keyword>smoking</keyword>
  <keyword>imagery</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>November 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT02968381/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Imagery Intervention</title>
          <description>Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.&#xD;
Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.</description>
        </group>
        <group group_id="P2">
          <title>Control Condition</title>
          <description>Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.&#xD;
Control Condition: Telephone coaching using standard cognitive behavioral methods</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Information on participants with available data is used in analyses.</population>
      <group_list>
        <group group_id="B1">
          <title>Imagery Intervention</title>
          <description>Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.&#xD;
Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.</description>
        </group>
        <group group_id="B2">
          <title>Control Condition</title>
          <description>Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.&#xD;
Control Condition: Telephone coaching using standard cognitive behavioral methods</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="56"/>
            <count group_id="B2" value="49"/>
            <count group_id="B3" value="105"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.5" spread="15.8"/>
                    <measurement group_id="B2" value="51.6" spread="14.5"/>
                    <measurement group_id="B3" value="50.5" spread="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</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>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Change in Self-reported 7-day Tobacco Abstinence From Baseline to Follow-up</title>
        <description>Tobacco use over the past seven days is assessed by project staff at 6-months post-enrollment. Tobacco use includes cigarettes, smokeless tobacco, and other types of tobacco. The question is asked &quot;Have you smoked, even a puff, in the last 7 days?&quot; &quot;Have you used any other form of tobacco in the last 7 days?&quot; If yes to either question, the participant is asked to indicate what type of tobacco was used and how much was used (e.g., &quot;how many cigarettes did you smoke on a typical day?&quot;).</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Imagery Intervention</title>
            <description>Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.&#xD;
Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.</description>
          </group>
          <group group_id="O2">
            <title>Control Condition</title>
            <description>Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.&#xD;
Control Condition: Telephone coaching using standard cognitive behavioral methods</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change in Self-reported 7-day Tobacco Abstinence From Baseline to Follow-up</title>
          <description>Tobacco use over the past seven days is assessed by project staff at 6-months post-enrollment. Tobacco use includes cigarettes, smokeless tobacco, and other types of tobacco. The question is asked &quot;Have you smoked, even a puff, in the last 7 days?&quot; &quot;Have you used any other form of tobacco in the last 7 days?&quot; If yes to either question, the participant is asked to indicate what type of tobacco was used and how much was used (e.g., &quot;how many cigarettes did you smoke on a typical day?&quot;).</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="56"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Change in Self-reported Tobacco 30-day Abstinence From Baseline to Follow-up</title>
        <description>Tobacco use over the past 30 days is assessed by project staff at 6-months post-enrollment. Tobacco use includes cigarettes, smokeless tobacco, and other types of tobacco. The question is asked &quot;Have you smoked, even a puff, in the last 30 days?&quot; &quot;Have you used any other form of tobacco in the last 30 days?&quot; If yes to either question, the participant is asked to indicate what type of tobacco was used and how much was used (e.g., &quot;how many cigarettes did you smoke on a typical day?&quot;).</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Imagery Intervention</title>
            <description>Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.&#xD;
Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.</description>
          </group>
          <group group_id="O2">
            <title>Control Condition</title>
            <description>Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.&#xD;
Control Condition: Telephone coaching using standard cognitive behavioral methods</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change in Self-reported Tobacco 30-day Abstinence From Baseline to Follow-up</title>
          <description>Tobacco use over the past 30 days is assessed by project staff at 6-months post-enrollment. Tobacco use includes cigarettes, smokeless tobacco, and other types of tobacco. The question is asked &quot;Have you smoked, even a puff, in the last 30 days?&quot; &quot;Have you used any other form of tobacco in the last 30 days?&quot; If yes to either question, the participant is asked to indicate what type of tobacco was used and how much was used (e.g., &quot;how many cigarettes did you smoke on a typical day?&quot;).</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="56"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Tobacco Use for Non-quitters From Baseline to Follow-up</title>
        <description>Assessed by project staff at 6-months post-enrollment.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Imagery Intervention</title>
            <description>Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.&#xD;
Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.</description>
          </group>
          <group group_id="O2">
            <title>Control Condition</title>
            <description>Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.&#xD;
Control Condition: Telephone coaching using standard cognitive behavioral methods</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Tobacco Use for Non-quitters From Baseline to Follow-up</title>
          <description>Assessed by project staff at 6-months post-enrollment.</description>
          <units>Cigarettes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" spread="6.1"/>
                    <measurement group_id="O2" value="11.2" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Self-efficacy for Quitting From Baseline to Follow-up</title>
        <description>An abbreviated version of the Condiotte and Lichtenstein (1981) Confidence Questionnaire consisting of 5 items for quitters and 6 items for non-quitters. All items are scored using a 5-point Likert scale where 1 is low/less and 5 is high/more. We calculated an average score of the items (which would have a value between 1 and 5).</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Imagery Intervention</title>
            <description>Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.&#xD;
Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.</description>
          </group>
          <group group_id="O2">
            <title>Control Condition</title>
            <description>Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.&#xD;
Control Condition: Telephone coaching using standard cognitive behavioral methods</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Self-efficacy for Quitting From Baseline to Follow-up</title>
          <description>An abbreviated version of the Condiotte and Lichtenstein (1981) Confidence Questionnaire consisting of 5 items for quitters and 6 items for non-quitters. All items are scored using a 5-point Likert scale where 1 is low/less and 5 is high/more. We calculated an average score of the items (which would have a value between 1 and 5).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="1.1"/>
                    <measurement group_id="O2" value="4.0" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Nicotine Cravings From Baseline to Follow-up</title>
        <description>This was assessed using 1 item adapted from the Shiffman (2004) Rating Scale (&quot;How much have you craved tobacco today?&quot;). Responses were coded using a 6-point Likert scale from &quot;not at all&quot; (code 0) to &quot;a great deal&quot; (code 5).</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Imagery Intervention</title>
            <description>Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.&#xD;
Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.</description>
          </group>
          <group group_id="O2">
            <title>Control Condition</title>
            <description>Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.&#xD;
Control Condition: Telephone coaching using standard cognitive behavioral methods</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Nicotine Cravings From Baseline to Follow-up</title>
          <description>This was assessed using 1 item adapted from the Shiffman (2004) Rating Scale (&quot;How much have you craved tobacco today?&quot;). Responses were coded using a 6-point Likert scale from &quot;not at all&quot; (code 0) to &quot;a great deal&quot; (code 5).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="1.2"/>
                    <measurement group_id="O2" value="2.2" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 months</time_frame>
      <desc>The intervention and control conditions were both cognitive behavioral and posed no risk to participants.</desc>
      <group_list>
        <group group_id="E1">
          <title>Imagery Intervention</title>
          <description>Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.&#xD;
Imagery Intervention: Telephone coaching sessions, use of guided imagery and website.</description>
        </group>
        <group group_id="E2">
          <title>Control Condition</title>
          <description>Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.&#xD;
Control Condition: Telephone coaching using standard cognitive behavioral methods</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="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </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="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Judith Gordon</name_or_title>
      <organization>University of Arizona</organization>
      <phone>520-626-4970</phone>
      <email>judithg@email.arizona.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/NCT02968381
org study id: 1R34AT008947
secondary id: 1R34AT008947
nct id: NCT02968381
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Tobacco use is still the leading cause of preventable disease and death in the United States.
      Tobacco quit lines are effective at helping smokers to quit, but quit lines are
      underutilized, especially by men and racial/ethnic minorities. Guided imagery is effective at
      helping people quit smoking, and is appealing to males and diverse racial groups, but has
      limited reach. The proposed study will develop and test the feasibility and acceptability of
      a guided imagery tobacco cessation intervention that is delivered by a combination of quit
      line coaches and an interactive website. The investigators hypothesize that guided mental
      imagery delivered using the quit line "coaching model" combined with an interactive website
      could be an effective intervention strategy.
The objective of this three year R34 application is to develop and test the feasibility of a
      theory-driven, telephone plus web-based, guided mental imagery intervention for smoking
      cessation.

      Aim 1. Develop a theory-based, guided mental imagery tobacco cessation intervention for quit
      line callers with input from expert consultants in health disparities and a Community
      Advisory Board representing diverse populations and tobacco control stakeholders. The
      intervention will include phone-based coaching, an interactive website, and optional
      cessation medication. It will be focus tested with 40 smokers (from diverse racial/ethnic and
      age groups with at least 40% males), and usability tested with 5 smokers.

      Aim 2. Develop training and competency standards for, and train, four coaches in the
      implementation of the guided imagery and control interventions. Coaches will be assessed at
      6-weeks and 6-months post-training for implementation fidelity and satisfaction.

      Aim 3. Conduct a feasibility trial (N=100) to gather preliminary data on the effects of the
      guided mental imagery intervention on quit line callers' tobacco use, cravings, and
      self-efficacy to quit smoking, and to refine study procedures, including recruitment,
      retention, and use of intervention components. Participants will be randomly assigned to
      receive either the Imagery Intervention (N=50) or an attention control condition (N=50) as
      delivered by study coaches. Participants will be assessed at baseline, 6-weeks and 6-months
      post-enrollment. Primary outcomes will be self-reported point prevalence and prolonged
      abstinence of tobacco use. Biochemical validation will be conducted on a sub-sample to
      determine validity of self-reported abstinence in this population. Secondary outcomes will be
      self-reported cravings and self-efficacy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of Participants With Change in Self-reported 7-day Tobacco Abstinence From Baseline to Follow-up
time frame: 6 months
description: Tobacco use over the past seven days is assessed by project staff at 6-months post-enrollment. Tobacco use includes cigarettes, smokeless tobacco, and other types of tobacco. The question is asked "Have you smoked, even a puff, in the last 7 days?" "Have you used any other form of tobacco in the last 7 days?" If yes to either question, the participant is asked to indicate what type of tobacco was used and how much was used (e.g., "how many cigarettes did you smoke on a typical day?").
measure: Number of Participants With Change in Self-reported Tobacco 30-day Abstinence From Baseline to Follow-up
time frame: 6 months
description: Tobacco use over the past 30 days is assessed by project staff at 6-months post-enrollment. Tobacco use includes cigarettes, smokeless tobacco, and other types of tobacco. The question is asked "Have you smoked, even a puff, in the last 30 days?" "Have you used any other form of tobacco in the last 30 days?" If yes to either question, the participant is asked to indicate what type of tobacco was used and how much was used (e.g., "how many cigarettes did you smoke on a typical day?").
measure: Change in Tobacco Use for Non-quitters From Baseline to Follow-up
time frame: 6 months
description: Assessed by project staff at 6-months post-enrollment.
measure: Change in Self-efficacy for Quitting From Baseline to Follow-up
time frame: 6 months
description: An abbreviated version of the Condiotte and Lichtenstein (1981) Confidence Questionnaire consisting of 5 items for quitters and 6 items for non-quitters. All items are scored using a 5-point Likert scale where 1 is low/less and 5 is high/more. We calculated an average score of the items (which would have a value between 1 and 5).
measure: Change in Nicotine Cravings From Baseline to Follow-up
time frame: 6 months
description: This was assessed using 1 item adapted from the Shiffman (2004) Rating Scale ("How much have you craved tobacco today?"). Responses were coded using a 6-point Likert scale from "not at all" (code 0) to "a great deal" (code 5).
arm group label: Imagery Intervention
arm group type: Experimental
description: Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.
arm group label: Control Condition
arm group type: Active Comparator
description: Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.
intervention type: Behavioral
intervention name: Imagery Intervention
description: Telephone coaching sessions, use of guided imagery and website.
arm group label: Imagery Intervention
intervention type: Behavioral
intervention name: Control Condition
description: Telephone coaching using standard cognitive behavioral methods
arm group label: Control Condition
other name: Active Comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Judith Gordon, PhD
role: Principal Investigator
affiliation: University of Arizona
facility: 
country: United States
url: http://SeeMeSmokeFree.com
description: Pilot project using guided imagery for tobacco cessation for women concerned about weight gain
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 