<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/NCT04417075</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001567</org_study_id>
    <secondary_id>1R41DA048692-01</secondary_id>
    <nct_id>NCT04417075</nct_id>
  </id_info>
  <brief_title>Mobile Smoking Treatment for Spanish-speaking Latinx Smokers</brief_title>
  <official_title>Culturally Sensitive, Evidence-based, Spanish Language Mobile App for Smoking Cessation for Latino Cigarette Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Houston</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aims of the project are to develop and test a Spanish language, mobile app for&#xD;
      smoking cessation called Impacto.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 38 Spanish-speaking, Latinx smokers with high anxiety sensitivity (AS) will be&#xD;
      recruited for this project. Eight (8) participants will complete user interviews in Spanish&#xD;
      and thirty (30) participants will participate in a randomized controlled trial (RCT) for&#xD;
      smoking cessation. Participants will be randomized to receive either the Impacto mobile app&#xD;
      or a generic, Spanish language, smoking cessation, mobile app control (Dejar de Fumar&#xD;
      Asistente).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 21, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>7-Day Point Prevalence Smoking Abstinence</measure>
    <time_frame>End of treatment (Week 8)</time_frame>
    <description>Self-reported 7-day point prevalence smoking status. Verification via carbon monoxide at end of treatment (10 weeks).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Smoking Rate (# cigarettes per day)</measure>
    <time_frame>Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)</time_frame>
    <description>We will assess the number of cigarettes smoking at each time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety Sensitivity</measure>
    <time_frame>Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)</time_frame>
    <description>Anxiety sensitivity will be assessed using the Anxiety Sensitivity Index-3 (ASI-3).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mood and Anxiety Symptoms</measure>
    <time_frame>Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)</time_frame>
    <description>The Mood and Anxiety Symptom Questionnaire (MASQ) is well-validated measure and will be used to assess anxiety/depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Adherence to Use of Impacto Mobile App (Impacto Condition Only)</measure>
    <time_frame>Daily over the course of the 8 weeks of participant study involvement</time_frame>
    <description>We will access these data via the &quot;back end&quot; of the Impacto server to evaluate whether the criterion of 75% daily adherence (i.e., app use on 75% of all possible days) has been achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User Satisfaction with the Impacto Mobile App (Impacto Condition Only) Condition Only)</measure>
    <time_frame>Weeks 2, 4, 6, and 8</time_frame>
    <description>User satisfaction ratings scored on a 1-9 Likert scale with higher scores indicating better user satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Impacto</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the mobile app to be developed and evaluated in this project.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dejar de Fumar Asistente</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Impacto (Mobile App)</intervention_name>
    <description>This is the mobile app to be developed and evaluated in this project. It is designed for Spanish-speaking, Latinx smokers with high anxiety sensitivity and will be built for the Android platform. The app will include components to address and remediate anxiety sensitivity, as well as having smoking cessation components.</description>
    <arm_group_label>Impacto</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dejar de Fumar Asistente (Mobile App)</intervention_name>
    <description>Dejar de Fumar Asistente (English version called: Quit Tracker: Stop Smoking) is a popular, free third party mobile application aimed at helping smokers quit smoking. This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto. This mobile app is well established as a smoking cessation app for Spanish-speaking, Latinx smokers. The app includes smoking cessation components but does not have a specific emphasis on anxiety sensitivity.</description>
    <arm_group_label>Dejar de Fumar Asistente</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1) 18 to 55 year of age, 2) current smoker (i.e., at least 6 cigarettes/day), 3) not&#xD;
        currently engaged in smoking cessation treatment, 4), high anxiety sensitivity (AS) score&#xD;
        defined as an ASI-III score of ≥ 23, 5) motivation to quit &gt; 5 on a 10 pt. scale, 6)&#xD;
        Spanish speaking, and 7) currently own an Android-compatible mobile phone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) use of other tobacco products (including e-cigarettes), 2) current non-nicotine&#xD;
        substance dependence and/or current or intended participation in a concurrent substance&#xD;
        abuse treatment, 3) ongoing psychotherapy of any duration directed specifically toward the&#xD;
        treatment of anxiety or depression, or 4) active suicidality (i.e., suicidal ideation,&#xD;
        intent, and/or plan) or current psychosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Justin M Shepherd, M.A.</last_name>
    <phone>713-743-8056</phone>
    <email>jmsheph4@central.uh.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pamella Nizio, B.S.</last_name>
      <phone>713-743-8056</phone>
      <email>niziopam@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Justin M Shepherd, M.A</last_name>
      <phone>713-743-8056</phone>
      <email>jmsheph4@central.uh.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Michael J Zvolensky, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Houston</investigator_affiliation>
    <investigator_full_name>Michael J. Zvolensky, Ph.D.</investigator_full_name>
    <investigator_title>Hugh Roy and Lillie Cranz Cullen Distinguished University Professor</investigator_title>
  </responsible_party>
  <keyword>Smoking Cessation</keyword>
  <keyword>Mobile App</keyword>
  <keyword>Anxiety Sensitivity</keyword>
  <!-- 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/NCT04417075
org study id: STUDY00001567
secondary id: 1R41DA048692-01
nct id: NCT04417075
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The specific aims of the project are to develop and test a Spanish language, mobile app for
      smoking cessation called Impacto.
A total of 38 Spanish-speaking, Latinx smokers with high anxiety sensitivity (AS) will be
      recruited for this project. Eight (8) participants will complete user interviews in Spanish
      and thirty (30) participants will participate in a randomized controlled trial (RCT) for
      smoking cessation. Participants will be randomized to receive either the Impacto mobile app
      or a generic, Spanish language, smoking cessation, mobile app control (Dejar de Fumar
      Asistente).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 7-Day Point Prevalence Smoking Abstinence
time frame: End of treatment (Week 8)
description: Self-reported 7-day point prevalence smoking status. Verification via carbon monoxide at end of treatment (10 weeks).
measure: Change in Smoking Rate (# cigarettes per day)
time frame: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
description: We will assess the number of cigarettes smoking at each time point.
measure: Change in Anxiety Sensitivity
time frame: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
description: Anxiety sensitivity will be assessed using the Anxiety Sensitivity Index-3 (ASI-3).
measure: Change in Mood and Anxiety Symptoms
time frame: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
description: The Mood and Anxiety Symptom Questionnaire (MASQ) is well-validated measure and will be used to assess anxiety/depressive symptoms.
measure: Daily Adherence to Use of Impacto Mobile App (Impacto Condition Only)
time frame: Daily over the course of the 8 weeks of participant study involvement
description: We will access these data via the "back end" of the Impacto server to evaluate whether the criterion of 75% daily adherence (i.e., app use on 75% of all possible days) has been achieved.
measure: User Satisfaction with the Impacto Mobile App (Impacto Condition Only) Condition Only)
time frame: Weeks 2, 4, 6, and 8
description: User satisfaction ratings scored on a 1-9 Likert scale with higher scores indicating better user satisfaction.
arm group label: Impacto
arm group type: Experimental
description: This is the mobile app to be developed and evaluated in this project.
arm group label: Dejar de Fumar Asistente
arm group type: Active Comparator
description: This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto.
intervention type: Behavioral
intervention name: Impacto (Mobile App)
description: This is the mobile app to be developed and evaluated in this project. It is designed for Spanish-speaking, Latinx smokers with high anxiety sensitivity and will be built for the Android platform. The app will include components to address and remediate anxiety sensitivity, as well as having smoking cessation components.
arm group label: Impacto
intervention type: Behavioral
intervention name: Dejar de Fumar Asistente (Mobile App)
description: Dejar de Fumar Asistente (English version called: Quit Tracker: Stop Smoking) is a popular, free third party mobile application aimed at helping smokers quit smoking. This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto. This mobile app is well established as a smoking cessation app for Spanish-speaking, Latinx smokers. The app includes smoking cessation components but does not have a specific emphasis on anxiety sensitivity.
arm group label: Dejar de Fumar Asistente
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Justin M Shepherd, M.A.
phone: 713-743-8056
email: jmsheph4@central.uh.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Houston
investigator full name: Michael J. Zvolensky, Ph.D.
investigator title: Hugh Roy and Lillie Cranz Cullen Distinguished University Professor