xml: <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/NCT05991934</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00013413-Pilot</org_study_id>
      <nct_id>NCT05991934</nct_id>
    </id_info>
    <brief_title>Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation</brief_title>
    <official_title>Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins Bloomberg School of Public Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Johns Hopkins Bloomberg School of Public Health</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>
        Clinical practice guidelines for smoking cessation emphasize cognitive behavioral therapy&#xD;
        (CBT) to help patients develop coping strategies for urges. Mindfulness or Acceptance and&#xD;
        commitment Therapy (ACT) offer a different approach, which teaches smokers psychological&#xD;
        flexibility through accepting negative experiences. While there is evidence for the efficacy&#xD;
        of both CBT and Mindfulness/ACT smoking cessation interventions, it is unclear if these&#xD;
        approaches are efficacious when implemented in real-time and with young adults. The overall&#xD;
        goal of this proposal is to evaluate the efficacy of CBT and Mindfulness/ACT messages for&#xD;
        young adults targeted at specific high-risk situations for smoking.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To conduct a pilot trial to test CBT and Mindfulness/ACT intervention message efficacy for&#xD;
        reducing momentary smoking urges (N=10). To inform just-in-time interventions, it is crucial&#xD;
        to test if CBT and Mindfulness/ACT based messages can reduce momentary smoking urges. The&#xD;
        investigators will conduct a micro-randomized trial (repeated within-subject randomizations&#xD;
        of messages) to accomplish this. In line with the investigators' existing protocol,&#xD;
        participants first collect Ecological Momentary Assessment (EMA) data for 14 days, allowing&#xD;
        the investigators to determine high-risk situations for smoking. In the following&#xD;
        intervention phase, participants receive tailored messages triggered by geofencing of&#xD;
        participants' high-risk locations for a total of 30 days. Tailoring is based on established&#xD;
        predictors of smoking relapse (stress and presence of other smokers). The micro-randomized&#xD;
        trial tests the efficacy of CBT versus Mindfulness/ACT versus control messages for reducing&#xD;
        smoking urge 15 minutes post message delivery. Secondary outcomes include smoking or other&#xD;
        tobacco use (including e-cigarettes), affect, and stress. After 45 days, follow up interviews&#xD;
        with participants will be conducted to collect information on their study experience.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>A pilot micro-randomized trial (within-subject randomization) with 10 young adult smokers will investigate the feasibility of delivering smoking cessation messages based on CBT and mindfulness/ACT for reducing smoking urge 15 minutes after message delivery.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in smoking urge as assessed by a single item</measure>
      <time_frame>Baseline, 5 minutes after message delivery</time_frame>
      <description>The primary outcome will be change in participants' rating of smoking urge in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys. Urge will be assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in number of cigarettes smoked per day in past week as assessed by a single item</measure>
      <time_frame>Baseline, 45-day follow-up</time_frame>
      <description>The primary outcome will be change in self-reported number of cigarettes smoked per day in the past week from baseline to 45-days.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Tobacco Cigarette Smoking</condition>
    <arm_group>
      <arm_group_label>Single arm pilot</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Smartphone-based intervention messages</intervention_name>
      <description>Intervention messages in the proposed trial will address specific high-risk situations for smoking and smoking urges. Messages will focus on two key situational triggers for message matching: 1. Stress (high/low) and 2. Presence of other smokers (yes/no). For each situation, characterized by a combination of these characteristics, several messages were developed. To improve user engagement with the intervention, all messages contain visual content in form of pictures.</description>
      <arm_group_label>Single arm pilot</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. live in the U.S.&#xD;
  &#xD;
            2. read English;&#xD;
  &#xD;
            3. are between 18 and 30 years of age;&#xD;
  &#xD;
            4. own an iPhone or Android smartphone;&#xD;
  &#xD;
            5. have smoked ≥100 cigarettes and currently smoke at least 1 cigarette per day on 3 or&#xD;
               more days of the week;&#xD;
  &#xD;
            6. are planning to quit smoking within the next 30 days.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  live internationally&#xD;
  &#xD;
            -  don't read English&#xD;
  &#xD;
            -  younger than 18, older than 30&#xD;
  &#xD;
            -  don't own a iPhone or Android smartphone&#xD;
  &#xD;
            -  have smoked less than 100 cigarettes&#xD;
  &#xD;
            -  not planning to quit smoking in the next 30 days&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Johannes Thrul, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Johannes Thrul, PhD</last_name>
      <phone>410-502-0925</phone>
      <email>jthrul@jhu.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Any individual requests for data will be honored on a case-by-case basis as deemed appropriate to the research protocol.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05991934
  org study id: IRB00013413-Pilot
  nct id: NCT05991934
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Clinical practice guidelines for smoking cessation emphasize cognitive behavioral therapy
        (CBT) to help patients develop coping strategies for urges. Mindfulness or Acceptance and
        commitment Therapy (ACT) offer a different approach, which teaches smokers psychological
        flexibility through accepting negative experiences. While there is evidence for the efficacy
        of both CBT and Mindfulness/ACT smoking cessation interventions, it is unclear if these
        approaches are efficacious when implemented in real-time and with young adults. The overall
        goal of this proposal is to evaluate the efficacy of CBT and Mindfulness/ACT messages for
        young adults targeted at specific high-risk situations for smoking.
  To conduct a pilot trial to test CBT and Mindfulness/ACT intervention message efficacy for
        reducing momentary smoking urges (N=10). To inform just-in-time interventions, it is crucial
        to test if CBT and Mindfulness/ACT based messages can reduce momentary smoking urges. The
        investigators will conduct a micro-randomized trial (repeated within-subject randomizations
        of messages) to accomplish this. In line with the investigators' existing protocol,
        participants first collect Ecological Momentary Assessment (EMA) data for 14 days, allowing
        the investigators to determine high-risk situations for smoking. In the following
        intervention phase, participants receive tailored messages triggered by geofencing of
        participants' high-risk locations for a total of 30 days. Tailoring is based on established
        predictors of smoking relapse (stress and presence of other smokers). The micro-randomized
        trial tests the efficacy of CBT versus Mindfulness/ACT versus control messages for reducing
        smoking urge 15 minutes post message delivery. Secondary outcomes include smoking or other
        tobacco use (including e-cigarettes), affect, and stress. After 45 days, follow up interviews
        with participants will be conducted to collect information on their study experience.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: A pilot micro-randomized trial (within-subject randomization) with 10 young adult smokers will investigate the feasibility of delivering smoking cessation messages based on CBT and mindfulness/ACT for reducing smoking urge 15 minutes after message delivery.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in smoking urge as assessed by a single item
  time frame: Baseline, 5 minutes after message delivery
  description: The primary outcome will be change in participants' rating of smoking urge in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys. Urge will be assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high).
  measure: Change in number of cigarettes smoked per day in past week as assessed by a single item
  time frame: Baseline, 45-day follow-up
  description: The primary outcome will be change in self-reported number of cigarettes smoked per day in the past week from baseline to 45-days.
  arm group label: Single arm pilot
  arm group type: Experimental
  description: The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization).
  intervention type: Behavioral
  intervention name: Smartphone-based intervention messages
  description: Intervention messages in the proposed trial will address specific high-risk situations for smoking and smoking urges. Messages will focus on two key situational triggers for message matching: 1. Stress (high/low) and 2. Presence of other smokers (yes/no). For each situation, characterized by a combination of these characteristics, several messages were developed. To improve user engagement with the intervention, all messages contain visual content in form of pictures.
  arm group label: Single arm pilot
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: No
  last name: Johannes Thrul, PhD
  role: Principal Investigator
  affiliation: Johns Hopkins Bloomberg School of Public Health
  last name: Johannes Thrul, PhD
  phone: 410-502-0925
  email: jthrul@jhu.edu
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Any individual requests for data will be honored on a case-by-case basis as deemed appropriate to the research protocol.