<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/NCT04421170</url>
  </required_header>
  <id_info>
    <org_study_id>20200129-33</org_study_id>
    <nct_id>NCT04421170</nct_id>
  </id_info>
  <brief_title>Efficacy of Smartphone App for Smoking Cessation in China</brief_title>
  <official_title>Efficacy of Cognitive Behavioral Therapy-based Smartphone App for Smoking Cessation in China: a Study Protocol of a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sir Run Run Shaw Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sir Run Run Shaw Hospital</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>
      This study aims to evaluate the efficacy of cognitive behavioral therapy (CBT)-based&#xD;
      cigarette smoking cessation smartphone app for treatment seeking smokers in China.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 23, 2021</start_date>
  <completion_date type="Anticipated">February 28, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biologically verified continuously smoking abstinence at week 26</measure>
    <time_frame>26 weeks</time_frame>
    <description>Participants in this study will be considered to be biologically verified continuously smoking abstinence if they report smoking no more than 5 cigarettes since the quit date and have an expired carbon monoxide concentration of less than 10 ppm (for local participants who will be able to go to the PI affiliated hospital) or a urine cotinine cutoff point of 200 ng/ml (cotinine urine dipsticks will be mailed to each participant's address, and test will be confirmed by video call and by family members) at week 26 (6 months) after quit date. This abstinence has been applied by the Society for Research on Nicotine and Tobacco (SRNT) (Hughes, Keely et al. 2003) and the 'Russell Standard' (West, Hajek et al. 2005).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>7-day point prevalence smoking abstinence</measure>
    <time_frame>26 weeks</time_frame>
    <description>7-day Point prevalence of smoking abstinence: not even a puff of smoke, for the last seven consecutive days, at 1, 2, 3, 4, 8, 12, 16, 20 and 26 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported continuous smoking abstinence</measure>
    <time_frame>26 weeks</time_frame>
    <description>Self-reported continuous smoking abstinence: a self-report of smoking ≤ 5 cigarettes from the past 1, 2, 3, 4, 8, 12, 16, 20 and 26 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reductions in number of cigarettes smoked per day</measure>
    <time_frame>26 weeks</time_frame>
    <description>Reductions in number of cigarettes smoked per day: will be assessed by comparing the number of cigarettes smoked per day at baseline and at 26 weeks. Cigarettes smoked per day: number of cigarettes smoked per day within seven days or the approximate total number of smoked cigarettes within seven days if not smoked daily.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Cigarette Smoking</condition>
  <condition>Smartphone App-based Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants from the intervention group will receive CBT based smoking cessation. It provides both mandatory information of evidence-based and guideline-based smoking cessation interventions, and optional information about quitting benefits, tips for quitting et al. The app will be available for the participants in the intervention group until 26-week post-quit date follow-up. After this period, the app will automatically stop the data collection, but they can continue to use it if they want. As the participants progressed through the study, smoking cessation related information will be gradually reduced until 12 weeks after quit date, and follow-up messages will be sent at 16, 20 and 26 weeks after quit date. Participants from intervention group can also seek for help at any time by text or WeChat, or make a phone call.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants from the control group will only receive information of thanking them for being in the study and reminding them of the time until their free month at the end of follow up. In order to measure the outcomes between two groups, continuous smoking abstinence, point prevalence of abstinence, how many cigarettes per day during the last week if they are still smoking will be checked at week 1, 2, 3, 4, 8, 12, 16, 20 and 26 points after quit date by ePRO software. Biochemically verified continuously abstinence will also be checked if they have reported continuous smoking abstinence at week 26 points after quit date.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>smartphone app for smoking cessation</intervention_name>
    <description>Paticipants will receive 12-week app-based smoking cessation intervention with follow-up to 26 weeks.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cigarette smokers (smoked more than 100 cigarettes in their lifetime, and currently&#xD;
             smoke five or more cigarettes a day)&#xD;
&#xD;
          2. 25 years of age or older&#xD;
&#xD;
          3. Being able to read and write in Chinese&#xD;
&#xD;
          4. Owning a smartphone&#xD;
&#xD;
          5. Have experience of using apps&#xD;
&#xD;
          6. Expressing an interest in quitting smoking within the next month&#xD;
&#xD;
          7. Willing to provide informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Nonsmokers&#xD;
&#xD;
          2. Only use electronic cigarettes&#xD;
&#xD;
          3. Smokers without attempts to quit smoking&#xD;
&#xD;
          4. Participants with severe mental illness&#xD;
&#xD;
          5. Participants who had already started their quit attempt or using any smoking cessation&#xD;
             treatment at the time of registration&#xD;
&#xD;
          6. Unable to use smartphone and apps&#xD;
&#xD;
          7. Unable to read and write in Chinese&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanhui Liao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yanhui Liao, MD</last_name>
    <phone>8615116225099</phone>
    <email>tangliaoyanhui@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yanhui Liao</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanhui Liao, MD</last_name>
      <phone>8615116225099</phone>
      <email>liaoyanhui@zju.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 7, 2022</last_update_submitted>
  <last_update_submitted_qc>January 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sir Run Run Shaw Hospital</investigator_affiliation>
    <investigator_full_name>Yanhui Liao</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected IPD, all IPD that underlie results in a publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Starting 1 month after publication.</ipd_time_frame>
    <ipd_access_criteria>Yanhui Liao will review requests and criteria for reviewing requests</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04421170
org study id: 20200129-33
nct id: NCT04421170
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the efficacy of cognitive behavioral therapy (CBT)-based
      cigarette smoking cessation smartphone app for treatment seeking smokers in China.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Biologically verified continuously smoking abstinence at week 26
time frame: 26 weeks
description: Participants in this study will be considered to be biologically verified continuously smoking abstinence if they report smoking no more than 5 cigarettes since the quit date and have an expired carbon monoxide concentration of less than 10 ppm (for local participants who will be able to go to the PI affiliated hospital) or a urine cotinine cutoff point of 200 ng/ml (cotinine urine dipsticks will be mailed to each participant's address, and test will be confirmed by video call and by family members) at week 26 (6 months) after quit date. This abstinence has been applied by the Society for Research on Nicotine and Tobacco (SRNT) (Hughes, Keely et al. 2003) and the 'Russell Standard' (West, Hajek et al. 2005).
measure: 7-day point prevalence smoking abstinence
time frame: 26 weeks
description: 7-day Point prevalence of smoking abstinence: not even a puff of smoke, for the last seven consecutive days, at 1, 2, 3, 4, 8, 12, 16, 20 and 26 weeks.
measure: Self-reported continuous smoking abstinence
time frame: 26 weeks
description: Self-reported continuous smoking abstinence: a self-report of smoking ≤ 5 cigarettes from the past 1, 2, 3, 4, 8, 12, 16, 20 and 26 weeks.
measure: Reductions in number of cigarettes smoked per day
time frame: 26 weeks
description: Reductions in number of cigarettes smoked per day: will be assessed by comparing the number of cigarettes smoked per day at baseline and at 26 weeks. Cigarettes smoked per day: number of cigarettes smoked per day within seven days or the approximate total number of smoked cigarettes within seven days if not smoked daily.
arm group label: Intervention Group
arm group type: Experimental
description: Participants from the intervention group will receive CBT based smoking cessation. It provides both mandatory information of evidence-based and guideline-based smoking cessation interventions, and optional information about quitting benefits, tips for quitting et al. The app will be available for the participants in the intervention group until 26-week post-quit date follow-up. After this period, the app will automatically stop the data collection, but they can continue to use it if they want. As the participants progressed through the study, smoking cessation related information will be gradually reduced until 12 weeks after quit date, and follow-up messages will be sent at 16, 20 and 26 weeks after quit date. Participants from intervention group can also seek for help at any time by text or WeChat, or make a phone call.
arm group label: Control group
arm group type: No Intervention
description: Participants from the control group will only receive information of thanking them for being in the study and reminding them of the time until their free month at the end of follow up. In order to measure the outcomes between two groups, continuous smoking abstinence, point prevalence of abstinence, how many cigarettes per day during the last week if they are still smoking will be checked at week 1, 2, 3, 4, 8, 12, 16, 20 and 26 points after quit date by ePRO software. Biochemically verified continuously abstinence will also be checked if they have reported continuous smoking abstinence at week 26 points after quit date.
intervention type: Behavioral
intervention name: smartphone app for smoking cessation
description: Paticipants will receive 12-week app-based smoking cessation intervention with follow-up to 26 weeks.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: No
last name: Yanhui Liao, MD
role: Principal Investigator
affiliation: Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
last name: Yanhui Liao, MD
phone: 8615116225099
email: tangliaoyanhui@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sir Run Run Shaw Hospital
investigator full name: Yanhui Liao
investigator title: Principal Investigator
sharing ipd: Yes
ipd description: All collected IPD, all IPD that underlie results in a publication.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Starting 1 month after publication.
ipd access criteria: Yanhui Liao will review requests and criteria for reviewing requests