<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/NCT02218281</url>
  </required_header>
  <id_info>
    <org_study_id>R34DA037886</org_study_id>
    <nct_id>NCT02218281</nct_id>
  </id_info>
  <brief_title>Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation</brief_title>
  <official_title>Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Massachusetts, Worcester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The recent Surgeon General's Report calls for effective and readily available treatment&#xD;
      approaches to help adolescent smokers interested in quitting. Schools are an ideal venue for&#xD;
      connecting adolescent smokers with smoking cessation assistance. This study will adapt the&#xD;
      Craving to Quit (C2Q) smartphone app, which integrates mindfulness training into a smoking&#xD;
      cessation program, for teen smokers (C2Q-Teen). We will test how well this novel app helps&#xD;
      teens stop smoking compared to another teen smoking cessation app that does not include&#xD;
      mindfulness training, and to written cessation information alone. If effective, the C2Q-Teen&#xD;
      would be relatively easy to disseminate widely and have tremendous public health significance&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The new Surgeon General's Report (SGR), Preventing Tobacco Use Among Youth and Young Adults,&#xD;
      highlights the addictive nature of nicotine and emphasizes the need for effective and&#xD;
      accessible cessation treatment for the more than 3.6 million youth who smoke. This proposal&#xD;
      is in response to PA-13-078, Behavioral and Integrative Treatment Development Program (R34),&#xD;
      which supports the development and testing of behavioral interventions targeting substance&#xD;
      abuse, including studies focused on Intervention generation and refinement (Stage IA), and&#xD;
      pilot or feasibility (Stage IB), and research designed to &quot;increase implementability of&#xD;
      interventions with creative use of technology&quot;. We have developed Craving to Quit (C2Q), a&#xD;
      smartphone intervention for smoking cessation for adults that integrates mindfulness training&#xD;
      (MT) into a smoking cessation curriculum. While MT has been shown to be efficacious for&#xD;
      smoking cessation in adults, it has not been tested in adolescents. In addition,&#xD;
      dissemination of MT is challenging due to the need for experienced MT therapists, high time&#xD;
      demand, difficulties in scheduling sessions, and high costs of in-person treatment delivery.&#xD;
      Mobile, smartphone technologies provide a promising medium for overcoming these barriers to&#xD;
      dissemination. We propose to adapt and refine our existing Craving to Quit (C2Q) app for use&#xD;
      by adolescent smokers (Stage IA), and to conduct feasibility and pilot testing (Stage IB) in&#xD;
      preparation for an R01 application to definitively test efficacy and probe psychological&#xD;
      mechanisms of change resulting from MT. In the pilot test, six public high schools will be&#xD;
      randomly assigned to one of three conditions, two schools per condition: (1) C2Q-Teen app&#xD;
      (smoking cessation delivered through a smartphone app via MT), (2) NCI's QuitSTART app&#xD;
      designed for teen smokers (NCI-QS) (smoking cessation delivered through a smartphone app&#xD;
      without MT), or (3) written smoking cessation materials only (MO). One hundred forty four&#xD;
      adolescent smokers interested in quitting will be recruited (24/school, 48/condition). School&#xD;
      nurses will introduce the three interventions in the school setting. Our first primary aim is&#xD;
      to adapt the C2Q app for use by adolescent smokers (C2Q-Teen). Our second primary aim is to&#xD;
      evaluate the feasibility and acceptability of the interventions to ensure adequacy of each&#xD;
      intervention for a larger RCT designed specifically to compare efficacy rates. Secondary aims&#xD;
      are to assess relative efficacy of the three interventions and independent contributions of&#xD;
      smartphone intervention delivery and mindfulness in increasing cotinine-validated 7-day point&#xD;
      prevalence abstinence at 3- and 6-month follow-up in order to adequately power a larger&#xD;
      trial, and to determine the relationship between C2Q-Teen usage and abstinence. If eventually&#xD;
      found to be effective, C2Q-Teen offers an innovative and potentially powerful intervention&#xD;
      for supporting teens in their efforts to quit that would be relatively easy to disseminate&#xD;
      widely and have tremendous public health significance, addressing the SGR's call for readily&#xD;
      available treatment for adolescent smokers wanting to quit&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of study recruitment into the three interventions</measure>
    <time_frame>Baseline</time_frame>
    <description>We will assess the ability to recruit 144 adolescents into the trial at baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of retention of participants at 3-month follow-up</measure>
    <time_frame>3-month follow-up</time_frame>
    <description>We will assess the ability to retain 80% of the 144 adolescents recruited at 3-month follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of retention of participants at 6-month follow-up</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>We will assess the ability to retain 80% of the 144 adolescents recruited at 6-month follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of the three interventions</measure>
    <time_frame>3-month follow-up</time_frame>
    <description>Assess the percentage of participants in each condition that indicate high utilization and acceptability ratings (at least 80% hypothesized)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cotinine-validated 7-day point prevalence abstinence</measure>
    <time_frame>3- and 6-months follow-up</time_frame>
    <description>Self-reported 7-day point abstinence confirmed by cotinine. Saliva samples will be collected from all participants prior to survey completion at each follow-up assessment. Samples will be analyzed for cotinine for all subjects reporting abstinence for the past 7 days. We will use cotinine-validated abstinence (cut-off of 11.4 ng/ml) and a cotinine-imputed abstinence when cotinine is missing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C2Q-Teen program usage as a predictor of smoking abstinence</measure>
    <time_frame>3- and 6-month follow-up</time_frame>
    <description>It is hypothesized that C2Q-Teen program usage, defined as self-report of the number of C2Q-Teen modules completed and informal mindfulness practice, will predict smoking abstinence at 3-month follow-up and at 6-month follow-up.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Cigarette Smoking</condition>
  <arm_group>
    <arm_group_label>C2Q-Teen app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Smoking cessation treatment delivered through a smartphone app via mindfulness training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NCI's QuitSTART app</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Smoking cessation treatment delivered through a smartphone app by NCI, without mindfulness training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Written smoking cessation materials only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receipt of written smoking cessation materials.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>C2Q-Teen app</intervention_name>
    <description>Commit to Quit (C2Q)-Teen app provides smoking cessation assistance incorporating mindfulness training.</description>
    <arm_group_label>C2Q-Teen app</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>NCI's QuitSTART app</intervention_name>
    <description>NCI's smoking cessation app</description>
    <arm_group_label>NCI's QuitSTART app</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Written smoking cessation materials only</intervention_name>
    <description>Receipt of written smoking cessation materials</description>
    <arm_group_label>Written smoking cessation materials only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  enrolled in grade 9-12&#xD;
&#xD;
          -  smoked at least 5 cigarettes on average per day for the past 7 days&#xD;
&#xD;
          -  interested in quitting smoking in the next three weeks&#xD;
&#xD;
          -  have a smartphone on iPhone or Android platforms&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable or unwilling to provide informed assent&#xD;
&#xD;
          -  diagnosis of a serious psychiatric illness during the past 5 years&#xD;
&#xD;
          -  developmental delay that would prevent study participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori Pbert, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Massachusetts, Worcester</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Judson Brewer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Massachusetts, Worcester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Massachusetts Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 25, 2016</last_update_submitted>
  <last_update_submitted_qc>August 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
    <investigator_full_name>Lori Pbert</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02218281
org study id: R34DA037886
nct id: NCT02218281
lead sponsor: 
has dmc: Yes
The recent Surgeon General's Report calls for effective and readily available treatment
      approaches to help adolescent smokers interested in quitting. Schools are an ideal venue for
      connecting adolescent smokers with smoking cessation assistance. This study will adapt the
      Craving to Quit (C2Q) smartphone app, which integrates mindfulness training into a smoking
      cessation program, for teen smokers (C2Q-Teen). We will test how well this novel app helps
      teens stop smoking compared to another teen smoking cessation app that does not include
      mindfulness training, and to written cessation information alone. If effective, the C2Q-Teen
      would be relatively easy to disseminate widely and have tremendous public health significance
The new Surgeon General's Report (SGR), Preventing Tobacco Use Among Youth and Young Adults,
      highlights the addictive nature of nicotine and emphasizes the need for effective and
      accessible cessation treatment for the more than 3.6 million youth who smoke. This proposal
      is in response to PA-13-078, Behavioral and Integrative Treatment Development Program (R34),
      which supports the development and testing of behavioral interventions targeting substance
      abuse, including studies focused on Intervention generation and refinement (Stage IA), and
      pilot or feasibility (Stage IB), and research designed to "increase implementability of
      interventions with creative use of technology". We have developed Craving to Quit (C2Q), a
      smartphone intervention for smoking cessation for adults that integrates mindfulness training
      (MT) into a smoking cessation curriculum. While MT has been shown to be efficacious for
      smoking cessation in adults, it has not been tested in adolescents. In addition,
      dissemination of MT is challenging due to the need for experienced MT therapists, high time
      demand, difficulties in scheduling sessions, and high costs of in-person treatment delivery.
      Mobile, smartphone technologies provide a promising medium for overcoming these barriers to
      dissemination. We propose to adapt and refine our existing Craving to Quit (C2Q) app for use
      by adolescent smokers (Stage IA), and to conduct feasibility and pilot testing (Stage IB) in
      preparation for an R01 application to definitively test efficacy and probe psychological
      mechanisms of change resulting from MT. In the pilot test, six public high schools will be
      randomly assigned to one of three conditions, two schools per condition: (1) C2Q-Teen app
      (smoking cessation delivered through a smartphone app via MT), (2) NCI's QuitSTART app
      designed for teen smokers (NCI-QS) (smoking cessation delivered through a smartphone app
      without MT), or (3) written smoking cessation materials only (MO). One hundred forty four
      adolescent smokers interested in quitting will be recruited (24/school, 48/condition). School
      nurses will introduce the three interventions in the school setting. Our first primary aim is
      to adapt the C2Q app for use by adolescent smokers (C2Q-Teen). Our second primary aim is to
      evaluate the feasibility and acceptability of the interventions to ensure adequacy of each
      intervention for a larger RCT designed specifically to compare efficacy rates. Secondary aims
      are to assess relative efficacy of the three interventions and independent contributions of
      smartphone intervention delivery and mindfulness in increasing cotinine-validated 7-day point
      prevalence abstinence at 3- and 6-month follow-up in order to adequately power a larger
      trial, and to determine the relationship between C2Q-Teen usage and abstinence. If eventually
      found to be effective, C2Q-Teen offers an innovative and potentially powerful intervention
      for supporting teens in their efforts to quit that would be relatively easy to disseminate
      widely and have tremendous public health significance, addressing the SGR's call for readily
      available treatment for adolescent smokers wanting to quit
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Feasibility of study recruitment into the three interventions
time frame: Baseline
description: We will assess the ability to recruit 144 adolescents into the trial at baseline.
measure: Feasibility of retention of participants at 3-month follow-up
time frame: 3-month follow-up
description: We will assess the ability to retain 80% of the 144 adolescents recruited at 3-month follow-up.
measure: Feasibility of retention of participants at 6-month follow-up
time frame: 6-month follow-up
description: We will assess the ability to retain 80% of the 144 adolescents recruited at 6-month follow-up.
measure: Acceptability of the three interventions
time frame: 3-month follow-up
description: Assess the percentage of participants in each condition that indicate high utilization and acceptability ratings (at least 80% hypothesized)
measure: Cotinine-validated 7-day point prevalence abstinence
time frame: 3- and 6-months follow-up
description: Self-reported 7-day point abstinence confirmed by cotinine. Saliva samples will be collected from all participants prior to survey completion at each follow-up assessment. Samples will be analyzed for cotinine for all subjects reporting abstinence for the past 7 days. We will use cotinine-validated abstinence (cut-off of 11.4 ng/ml) and a cotinine-imputed abstinence when cotinine is missing.
measure: C2Q-Teen program usage as a predictor of smoking abstinence
time frame: 3- and 6-month follow-up
description: It is hypothesized that C2Q-Teen program usage, defined as self-report of the number of C2Q-Teen modules completed and informal mindfulness practice, will predict smoking abstinence at 3-month follow-up and at 6-month follow-up.
arm group label: C2Q-Teen app
arm group type: Experimental
description: Smoking cessation treatment delivered through a smartphone app via mindfulness training.
arm group label: NCI's QuitSTART app
arm group type: Active Comparator
description: Smoking cessation treatment delivered through a smartphone app by NCI, without mindfulness training.
arm group label: Written smoking cessation materials only
arm group type: Active Comparator
description: Receipt of written smoking cessation materials.
intervention type: Behavioral
intervention name: C2Q-Teen app
description: Commit to Quit (C2Q)-Teen app provides smoking cessation assistance incorporating mindfulness training.
arm group label: C2Q-Teen app
intervention type: Behavioral
intervention name: NCI's QuitSTART app
description: NCI's smoking cessation app
arm group label: NCI's QuitSTART app
intervention type: Behavioral
intervention name: Written smoking cessation materials only
description: Receipt of written smoking cessation materials
arm group label: Written smoking cessation materials only
criteria: 
gender: All
minimum age: 13 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lori Pbert, PhD
role: Principal Investigator
affiliation: University of Massachusetts, Worcester
last name: Judson Brewer, MD
role: Principal Investigator
affiliation: University of Massachusetts, Worcester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Worcester
investigator full name: Lori Pbert
investigator title: Professor of Medicine