<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/NCT04502524</url>
  </required_header>
  <id_info>
    <org_study_id>RG1007109</org_study_id>
    <secondary_id>NCI-2020-05587</secondary_id>
    <secondary_id>R21CA236980</secondary_id>
    <secondary_id>10097</secondary_id>
    <nct_id>NCT04502524</nct_id>
  </id_info>
  <brief_title>Website Smoking Cessation Intervention for the Promotion of Smoking Cessation in Low-Income Veterans</brief_title>
  <official_title>A Scalable e-Health Smoking Cessation Intervention for Socioeconomically Disadvantaged Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Fred Hutchinson Cancer Center</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>
      This phase I trial studies how well a new electronic (e)-health smoking cessation program&#xD;
      (called Vet Flexiquit) works in promoting smoking cessation in low-income veterans who may or&#xD;
      may not be ready to quit smoking. The study will compare the new website smoking cessation&#xD;
      program to the current standard care website smoking cessation program offered by the&#xD;
      Veterans Administration (VA). Both website interventions will be accompanied by a text&#xD;
      messaging program that includes: (1) motivational messages, and (2) reminders to use the&#xD;
      assigned program. Both of the website interventions can help smokers quit or cut back on how&#xD;
      much they smoke, thus dramatically reducing their chances of developing tobacco-related&#xD;
      health conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE: Participants are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Participants use the new website smoking cessation program, which provides values&#xD;
      driven, mindfulness based coping skills and utilizes non-judgmental acceptance of&#xD;
      uncomfortable internal states like cravings. Participants also receive text messages&#xD;
      consisting of motivational messages and reminders to use the program. At the end of the&#xD;
      program, participants receive an email with handouts and available resources provided by the&#xD;
      VA for continued support for smoking cessation.&#xD;
&#xD;
      ARM II: Participants use the VA standard of care website, which provides educational&#xD;
      materials about cessation treatments, tools to cope with urges and relapse, how to stay&#xD;
      motivated, and brief tips on coping with physical and mental health problems. Participants&#xD;
      also receive text messages consisting of motivational messages and reminders to use the&#xD;
      program. At the end of the program, participants receive an email with a handout of available&#xD;
      resources provided by the VA for continued support for smoking cessation.&#xD;
&#xD;
      After study randomization, participants are followed up at 1 and 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2021</start_date>
  <completion_date type="Actual">January 28, 2022</completion_date>
  <primary_completion_date type="Actual">January 28, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction With Assigned Treatment</measure>
    <time_frame>At 3 months post-randomization</time_frame>
    <description>Satisfaction ratings regarding the usefulness of specific components of the website program, user comments and suggestions for improvement, presented descriptively. Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from &quot;not at all satisfied&quot; to &quot;very satisfied&quot;. Will dichotomize values at a threshold of &quot;somewhat satisfied&quot; or higher. We tested for differences between arms using a Fisher's Exact test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Server-recorded Logins to Assigned Website</measure>
    <time_frame>At 3 months</time_frame>
    <description>Will use negative binomial regression with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare treatment effects on the count outcome number of logins. There were no potential confounders to adjust for.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Website Use (Days Since First Login)</measure>
    <time_frame>At 3 months</time_frame>
    <description>Will use negative binomial regression with adjustment for the stratification variable baseline readiness to quit (high versus low) to compare treatment groups on the secondary acceptability outcome of duration of site usage (number of days elapsed from first to last use). There were no confounders to adjust for.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Quit Attempts</measure>
    <time_frame>At 3 months</time_frame>
    <description>Will use a negative binomial model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare the count outcome number of quit attempts between arms. There were no confounders to address for.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cotinine-confirmed, Self-reported Abstinence From Smoking</measure>
    <time_frame>In the 7 days prior to the 3-month follow up</time_frame>
    <description>Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered as continued smokers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cotinine-confirmed, Self-reported Abstinence From Smoking</measure>
    <time_frame>In the 30 days prior to the 3-month follow up</time_frame>
    <description>Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered continued smokers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy)</measure>
    <time_frame>In the 7 days prior to the 3-month follow up</time_frame>
    <description>Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. The missing responses were considered continued smokers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Readiness to Quit</measure>
    <time_frame>Baseline up to 3-month follow-up</time_frame>
    <description>Will be assessed by the Contemplation Ladder on a scale from 0 (no thought about quitting) to 10 (taking action to quit). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Acceptance of Smoking Triggers</measure>
    <time_frame>Baseline up to 3-month follow-up</time_frame>
    <description>Will be assessed by the Avoidance and Inflexibility Scale (AIS) on a scale ranging from 0 (never/not at all) to 4 (always/very much/extensively). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for. This is the AIS Feelings score change.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Cigarette Smoking-Related Carcinoma</condition>
  <arm_group>
    <arm_group_label>Arm I (New website program, handout, text message)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (Standard care VA website, handout, text message)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking Cessation Intervention (New website)</intervention_name>
    <description>Complete the new website smoking cessation program</description>
    <arm_group_label>Arm I (New website program, handout, text message)</arm_group_label>
    <other_name>Smoking and Tobacco Use Cessation Interventions</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking Cessation Intervention (Standard of care website)</intervention_name>
    <description>Complete the standard of care website smoking cessation intervention</description>
    <arm_group_label>Arm II (Standard care VA website, handout, text message)</arm_group_label>
    <other_name>standard of care</other_name>
    <other_name>standard therapy</other_name>
    <other_name>best practice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Education</intervention_name>
    <description>Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.</description>
    <arm_group_label>Arm I (New website program, handout, text message)</arm_group_label>
    <arm_group_label>Arm II (Standard care VA website, handout, text message)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health Promotion and Education</intervention_name>
    <description>Receive motivational and reminder text messages</description>
    <arm_group_label>Arm I (New website program, handout, text message)</arm_group_label>
    <arm_group_label>Arm II (Standard care VA website, handout, text message)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (New website program, handout, text message)</arm_group_label>
    <arm_group_label>Arm II (Standard care VA website, handout, text message)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be a US veteran&#xD;
&#xD;
          -  Participants must be low-income, as defined by falling below Veterans Health&#xD;
             Administration (VHA) national income threshold for no-cost healthcare&#xD;
&#xD;
          -  Participants must be a current smoker, averaging at least 5 cigarettes/day for the&#xD;
             last 30 days&#xD;
&#xD;
          -  Participants must have weekly internet access for the next 3 months&#xD;
&#xD;
          -  Participants must self-report current use of a personal email address to receive the&#xD;
             link to their assigned web site&#xD;
&#xD;
          -  Participants must self-report being willing to complete all study activities&#xD;
&#xD;
          -  Participants must be willing to receive study-related text messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently taking part in any other smoking cessation treatment such as the nicotine&#xD;
             patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a&#xD;
             web-based or app-based cessation program&#xD;
&#xD;
          -  Have recent (past 30 days) substance use disorder, suicidal ideation, or psychiatric&#xD;
             hospitalization&#xD;
&#xD;
          -  Previous participation in the treatment development stage of the new smoking cessation&#xD;
             website program&#xD;
&#xD;
          -  Prior use of the SmokefreeVET web site&#xD;
&#xD;
          -  Member of the same household as another research participant&#xD;
&#xD;
          -  Woman who is pregnant or breastfeeding, or planning to become pregnant&#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>Jaimee Heffner</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bedford VA Research Corporation, Inc.</name>
      <address>
        <city>Bedford</city>
        <state>Massachusetts</state>
        <zip>01730</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <results_first_submitted>January 26, 2023</results_first_submitted>
  <results_first_submitted_qc>March 14, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 7, 2023</results_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fred Hutchinson Cancer Center</investigator_affiliation>
    <investigator_full_name>Jaimee Heffner</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <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>April 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT04502524/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT04502524/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Fifty-three participants were eligible and enrolled in the study. The final sample comprised 49 participants who were randomized between February 3, 2021 and October 22, 2021.</recruitment_details>
      <pre_assignment_details>Four participants who were enrolled in the study were not randomized because they were lost to follow-up (n=3) or they withdrew (n=1) prior to randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm I (New Website Program, Handout, Text Message)</title>
          <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
        </group>
        <group group_id="P2">
          <title>Arm II (Standard Care VA Website, Handout, Text Message)</title>
          <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Arm I (New Website Program, Handout, Text Message)</title>
          <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
        </group>
        <group group_id="B2">
          <title>Arm II (Standard Care VA Website, Handout, Text Message)</title>
          <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</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="25"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="49"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.9" lower_limit="26" upper_limit="74"/>
                    <measurement group_id="B2" value="54.8" lower_limit="27" upper_limit="84"/>
                    <measurement group_id="B3" value="51.3" lower_limit="26" upper_limit="84"/>
                  </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="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="37"/>
                  </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="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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="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="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>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>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="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fagerström Test for Nicotine Dependence (FTND)</title>
          <description>The 6-item Fagerström Test for Nicotine Dependence (FTND) was used to assess degree of physical dependence on nicotine. Scale range is from 0-10. Higher scores indicate higher dependence.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.3" lower_limit="0.0" upper_limit="8"/>
                    <measurement group_id="B2" value="4.2" lower_limit="0.0" upper_limit="7"/>
                    <measurement group_id="B3" value="4.3" lower_limit="0.0" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Contemplation Ladder</title>
          <description>Range is from 0-10. Higher scores indicate greater readiness to quit.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.0" spread="2.3"/>
                    <measurement group_id="B2" value="7.8" spread="2.1"/>
                    <measurement group_id="B3" value="7.9" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Satisfaction With Assigned Treatment</title>
        <description>Satisfaction ratings regarding the usefulness of specific components of the website program, user comments and suggestions for improvement, presented descriptively. Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from &quot;not at all satisfied&quot; to &quot;very satisfied&quot;. Will dichotomize values at a threshold of &quot;somewhat satisfied&quot; or higher. We tested for differences between arms using a Fisher's Exact test.</description>
        <time_frame>At 3 months post-randomization</time_frame>
        <population>All survey respondents</population>
        <group_list>
          <group group_id="O1">
            <title>Arm I (New Website Program, Handout, Text Message)</title>
            <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Standard Care VA Website, Handout, Text Message)</title>
            <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Assigned Treatment</title>
          <description>Satisfaction ratings regarding the usefulness of specific components of the website program, user comments and suggestions for improvement, presented descriptively. Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from &quot;not at all satisfied&quot; to &quot;very satisfied&quot;. Will dichotomize values at a threshold of &quot;somewhat satisfied&quot; or higher. We tested for differences between arms using a Fisher's Exact test.</description>
          <population>All survey respondents</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="17"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not At All/A Little</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somewhat/Mostly/Very Much</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="18"/>
                  </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>
            <groups_desc>For overall satisfaction, a reliable estimate could not be calculated using a logistic regression model as all the responses were the same in the Vet Flexiquit arm. We calculated the p-value using the Fisher's exact test.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.999</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Server-recorded Logins to Assigned Website</title>
        <description>Will use negative binomial regression with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare treatment effects on the count outcome number of logins. There were no potential confounders to adjust for.</description>
        <time_frame>At 3 months</time_frame>
        <population>All survey respondents.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm I (New Website Program, Handout, Text Message)</title>
            <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Standard Care VA Website, Handout, Text Message)</title>
            <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Server-recorded Logins to Assigned Website</title>
          <description>Will use negative binomial regression with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare treatment effects on the count outcome number of logins. There were no potential confounders to adjust for.</description>
          <population>All survey respondents.</population>
          <units>Count of number of times logged in</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="3.6"/>
                    <measurement group_id="O2" value="3.2" spread="4.1"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.852</p_value>
            <method>Regression, negative binomial</method>
            <param_type>Slope</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.46</ci_lower_limit>
            <ci_upper_limit>0.56</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Duration of Website Use (Days Since First Login)</title>
        <description>Will use negative binomial regression with adjustment for the stratification variable baseline readiness to quit (high versus low) to compare treatment groups on the secondary acceptability outcome of duration of site usage (number of days elapsed from first to last use). There were no confounders to adjust for.</description>
        <time_frame>At 3 months</time_frame>
        <population>All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm I (New Website Program, Handout, Text Message)</title>
            <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Standard Care VA Website, Handout, Text Message)</title>
            <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Website Use (Days Since First Login)</title>
          <description>Will use negative binomial regression with adjustment for the stratification variable baseline readiness to quit (high versus low) to compare treatment groups on the secondary acceptability outcome of duration of site usage (number of days elapsed from first to last use). There were no confounders to adjust for.</description>
          <population>All randomized participants.</population>
          <units>Days since first login</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.7" spread="27.3"/>
                    <measurement group_id="O2" value="26.7" spread="47.2"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.451</p_value>
            <method>Regression, negative binomial</method>
            <param_type>Slope</param_type>
            <param_value>-0.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.60</ci_lower_limit>
            <ci_upper_limit>0.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Quit Attempts</title>
        <description>Will use a negative binomial model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare the count outcome number of quit attempts between arms. There were no confounders to address for.</description>
        <time_frame>At 3 months</time_frame>
        <population>All survey respondents.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm I (New Website Program, Handout, Text Message)</title>
            <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Standard Care VA Website, Handout, Text Message)</title>
            <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Quit Attempts</title>
          <description>Will use a negative binomial model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare the count outcome number of quit attempts between arms. There were no confounders to address for.</description>
          <population>All survey respondents.</population>
          <units>Number of quit attempts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.1"/>
                    <measurement group_id="O2" value="3.2" spread="6.7"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.508</p_value>
            <method>Regression, negative binomial</method>
            <param_type>Slope</param_type>
            <param_value>-0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.46</ci_lower_limit>
            <ci_upper_limit>0.003</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cotinine-confirmed, Self-reported Abstinence From Smoking</title>
        <description>Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered as continued smokers.</description>
        <time_frame>In the 7 days prior to the 3-month follow up</time_frame>
        <population>All survey respondents.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm I (New Website Program, Handout, Text Message)</title>
            <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Standard Care VA Website, Handout, Text Message)</title>
            <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
        </group_list>
        <measure>
          <title>Cotinine-confirmed, Self-reported Abstinence From Smoking</title>
          <description>Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered as continued smokers.</description>
          <population>All survey respondents.</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="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.602</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>3.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cotinine-confirmed, Self-reported Abstinence From Smoking</title>
        <description>Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered continued smokers.</description>
        <time_frame>In the 30 days prior to the 3-month follow up</time_frame>
        <population>All survey respondents.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm I (New Website Program, Handout, Text Message)</title>
            <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Standard Care VA Website, Handout, Text Message)</title>
            <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
        </group_list>
        <measure>
          <title>Cotinine-confirmed, Self-reported Abstinence From Smoking</title>
          <description>Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered continued smokers.</description>
          <population>All survey respondents.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.941</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.17</ci_lower_limit>
            <ci_upper_limit>5.29</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy)</title>
        <description>Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. The missing responses were considered continued smokers.</description>
        <time_frame>In the 7 days prior to the 3-month follow up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I (New Website Program, Handout, Text Message)</title>
            <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Standard Care VA Website, Handout, Text Message)</title>
            <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
        </group_list>
        <measure>
          <title>Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy)</title>
          <description>Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. The missing responses were considered continued smokers.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.612</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.09</ci_lower_limit>
            <ci_upper_limit>4.12</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Readiness to Quit</title>
        <description>Will be assessed by the Contemplation Ladder on a scale from 0 (no thought about quitting) to 10 (taking action to quit). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for.</description>
        <time_frame>Baseline up to 3-month follow-up</time_frame>
        <population>All survey respondents.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm I (New Website Program, Handout, Text Message)</title>
            <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Standard Care VA Website, Handout, Text Message)</title>
            <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Readiness to Quit</title>
          <description>Will be assessed by the Contemplation Ladder on a scale from 0 (no thought about quitting) to 10 (taking action to quit). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for.</description>
          <population>All survey respondents.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="3.3"/>
                    <measurement group_id="O2" value="-0.5" spread="3.6"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.504</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>0.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.13</ci_lower_limit>
            <ci_upper_limit>2.26</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Acceptance of Smoking Triggers</title>
        <description>Will be assessed by the Avoidance and Inflexibility Scale (AIS) on a scale ranging from 0 (never/not at all) to 4 (always/very much/extensively). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for. This is the AIS Feelings score change.</description>
        <time_frame>Baseline up to 3-month follow-up</time_frame>
        <population>All survey respondents.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm I (New Website Program, Handout, Text Message)</title>
            <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Standard Care VA Website, Handout, Text Message)</title>
            <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Acceptance of Smoking Triggers</title>
          <description>Will be assessed by the Avoidance and Inflexibility Scale (AIS) on a scale ranging from 0 (never/not at all) to 4 (always/very much/extensively). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for. This is the AIS Feelings score change.</description>
          <population>All survey respondents.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.6"/>
                    <measurement group_id="O2" value="0.3" spread="0.8"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.670</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.40</ci_lower_limit>
            <ci_upper_limit>0.61</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3-months</time_frame>
      <desc>Volunteered adverse events collected throughout the 3-month follow-up.</desc>
      <group_list>
        <group group_id="E1">
          <title>Arm I (New Website Program, Handout, Text Message)</title>
          <description>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</description>
        </group>
        <group group_id="E2">
          <title>Arm II (Standard Care VA Website, Handout, Text Message)</title>
          <description>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.&#xD;
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention&#xD;
Health Education: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.&#xD;
Health Promotion and Education: Receive motivational and reminder text messages&#xD;
Questionnaire Administration: Ancillary studies</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </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>
    <limitations_and_caveats>The goal was to establish feasibility rather than to detect statistically significant differences between arms. The sample size was small, and follow-ups were limited to short-term outcomes. Some ACT interventions have demonstrated greater effects when evaluated at long-term follow-up. This study was conducted during the COVID-19 pandemic, which represents a unique context. The study design was also impacted by the pandemic, transforming a primarily in-person design to a fully remote one.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jaimee Heffner, Ph.D., Associate Professor</name_or_title>
      <organization>Fred Hutchinson Cancer Center</organization>
      <phone>206.667.7314</phone>
      <email>jheffner@fredhutch.org</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/NCT04502524
org study id: RG1007109
secondary id: NCI-2020-05587
secondary id: R21CA236980
secondary id: 10097
nct id: NCT04502524
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This phase I trial studies how well a new electronic (e)-health smoking cessation program
      (called Vet Flexiquit) works in promoting smoking cessation in low-income veterans who may or
      may not be ready to quit smoking. The study will compare the new website smoking cessation
      program to the current standard care website smoking cessation program offered by the
      Veterans Administration (VA). Both website interventions will be accompanied by a text
      messaging program that includes: (1) motivational messages, and (2) reminders to use the
      assigned program. Both of the website interventions can help smokers quit or cut back on how
      much they smoke, thus dramatically reducing their chances of developing tobacco-related
      health conditions.
OUTLINE: Participants are randomized to 1 of 2 arms.

      ARM I: Participants use the new website smoking cessation program, which provides values
      driven, mindfulness based coping skills and utilizes non-judgmental acceptance of
      uncomfortable internal states like cravings. Participants also receive text messages
      consisting of motivational messages and reminders to use the program. At the end of the
      program, participants receive an email with handouts and available resources provided by the
      VA for continued support for smoking cessation.

      ARM II: Participants use the VA standard of care website, which provides educational
      materials about cessation treatments, tools to cope with urges and relapse, how to stay
      motivated, and brief tips on coping with physical and mental health problems. Participants
      also receive text messages consisting of motivational messages and reminders to use the
      program. At the end of the program, participants receive an email with a handout of available
      resources provided by the VA for continued support for smoking cessation.

      After study randomization, participants are followed up at 1 and 3 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Satisfaction With Assigned Treatment
time frame: At 3 months post-randomization
description: Satisfaction ratings regarding the usefulness of specific components of the website program, user comments and suggestions for improvement, presented descriptively. Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from "not at all satisfied" to "very satisfied". Will dichotomize values at a threshold of "somewhat satisfied" or higher. We tested for differences between arms using a Fisher's Exact test.
measure: Number of Server-recorded Logins to Assigned Website
time frame: At 3 months
description: Will use negative binomial regression with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare treatment effects on the count outcome number of logins. There were no potential confounders to adjust for.
measure: Duration of Website Use (Days Since First Login)
time frame: At 3 months
description: Will use negative binomial regression with adjustment for the stratification variable baseline readiness to quit (high versus low) to compare treatment groups on the secondary acceptability outcome of duration of site usage (number of days elapsed from first to last use). There were no confounders to adjust for.
measure: Number of Quit Attempts
time frame: At 3 months
description: Will use a negative binomial model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare the count outcome number of quit attempts between arms. There were no confounders to address for.
measure: Cotinine-confirmed, Self-reported Abstinence From Smoking
time frame: In the 7 days prior to the 3-month follow up
description: Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered as continued smokers.
measure: Cotinine-confirmed, Self-reported Abstinence From Smoking
time frame: In the 30 days prior to the 3-month follow up
description: Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered continued smokers.
measure: Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy)
time frame: In the 7 days prior to the 3-month follow up
description: Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. The missing responses were considered continued smokers.
measure: Change in Readiness to Quit
time frame: Baseline up to 3-month follow-up
description: Will be assessed by the Contemplation Ladder on a scale from 0 (no thought about quitting) to 10 (taking action to quit). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for.
measure: Change in Acceptance of Smoking Triggers
time frame: Baseline up to 3-month follow-up
description: Will be assessed by the Avoidance and Inflexibility Scale (AIS) on a scale ranging from 0 (never/not at all) to 4 (always/very much/extensively). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for. This is the AIS Feelings score change.
arm group label: Arm I (New website program, handout, text message)
arm group type: Experimental
description: Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation.
arm group label: Arm II (Standard care VA website, handout, text message)
arm group type: Active Comparator
description: Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.
intervention type: Behavioral
intervention name: Smoking Cessation Intervention (New website)
description: Complete the new website smoking cessation program
arm group label: Arm I (New website program, handout, text message)
other name: Smoking and Tobacco Use Cessation Interventions
intervention type: Behavioral
intervention name: Smoking Cessation Intervention (Standard of care website)
description: Complete the standard of care website smoking cessation intervention
arm group label: Arm II (Standard care VA website, handout, text message)
other name: standard of care
other name: standard therapy
other name: best practice
intervention type: Behavioral
intervention name: Health Education
description: Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.
arm group label: Arm I (New website program, handout, text message)
arm group label: Arm II (Standard care VA website, handout, text message)
intervention type: Other
intervention name: Health Promotion and Education
description: Receive motivational and reminder text messages
arm group label: Arm I (New website program, handout, text message)
arm group label: Arm II (Standard care VA website, handout, text message)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (New website program, handout, text message)
arm group label: Arm II (Standard care VA website, handout, text message)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jaimee Heffner
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Fred Hutchinson Cancer Center
investigator full name: Jaimee Heffner
investigator title: Associate Professor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The goal was to establish feasibility rather than to detect statistically significant differences between arms. The sample size was small, and follow-ups were limited to short-term outcomes. Some ACT interventions have demonstrated greater effects when evaluated at long-term follow-up. This study was conducted during the COVID-19 pandemic, which represents a unique context. The study design was also impacted by the pandemic, transforming a primarily in-person design to a fully remote one.
point of contact: 