<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/NCT03006653</url>
  </required_header>
  <id_info>
    <org_study_id>16-693</org_study_id>
    <nct_id>NCT03006653</nct_id>
  </id_info>
  <brief_title>Understanding Daily Fluctuations in Self-Regulation</brief_title>
  <official_title>Understanding Daily Fluctuations in Self-Regulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sage Bionetworks</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Understanding Daily Fluctuations in Self-Regulation, also known as the Digital Marshmallow&#xD;
      Test (DMT), is a collaboration by Northwell Health, Cornell Tech, and Sage Bionetworks.&#xD;
      Funded by the Robert Wood Johnson Foundation, this is a pioneering study to advance the&#xD;
      science in identifying and helping individuals who act on short-term temptations, despite&#xD;
      long-term consequences. Using Apple's ResearchKit(™) and Android's ResearchStack&#xD;
      applications, the Digital Marshmallow Test will leverage the powerful capabilities of the&#xD;
      smartphone to examine impulsivity using a range of game-like tasks and sensor capabilities&#xD;
      within the mobile phone. Across studies, more impulsive individuals are significantly more&#xD;
      likely to suffer from obesity, Type II Diabetes, substance abuse, gambling problems, suicidal&#xD;
      behaviors, and increased criminality among many other problems. Early self-report studies&#xD;
      reveal a relationship between the inability to delay gratification and different patterns of&#xD;
      mobile phone use. This will be the first study to develop non-invasive mobile methods to&#xD;
      identify and help those at greatest risk for impulsive responding before serious problems&#xD;
      occur.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Poor self-regulation and impulsivity are underlying symptoms of numerous mental health&#xD;
      problems such as obesity, substance abuse, Attention Deficit Hyperactivity Disorder (ADHD),&#xD;
      gambling, binge eating, bipolar disorder, borderline personality disorder, and suicidal&#xD;
      behaviors. This makes it one of the most important personal and public health intervention&#xD;
      targets. The classic Marshmallow Test done by Mischel and colleagues determined that the&#xD;
      inability to delay gratification in childhood was predictive of lower Scholastic Aptitude&#xD;
      Test (SAT) scores and higher BMI in adulthood. However, assessments of impulsivity and poor&#xD;
      self-regulation are rarely included in routine medical care because of time and financial&#xD;
      constraints.&#xD;
&#xD;
      The mobile phone has changed our ability to assess and intervene with individuals remotely,&#xD;
      providing an avenue for ambulatory diagnostic testing and just-in-time adaptive interventions&#xD;
      that can be accessed by billions of people. Newer methods of assessment using the mobile&#xD;
      phone, including Apple's ResearchKit, provide the opportunity for powerful assessments of&#xD;
      impulsivity beyond simple self-report. To date, there have been no measures of impulsivity&#xD;
      integrated into ResearchKit or any mobile application, aside from the beta version that the&#xD;
      investigators recently built, nor has the research community explored the possibilities of&#xD;
      passive impulsivity assessment using mobile analytics embedded in all phones. There is&#xD;
      preliminary evidence that mobile analytics, such as latency to respond to a text, can predict&#xD;
      personality traits associated with impulsivity such as extroversion and neuroticism, and&#xD;
      self-report studies reveal that there is a direct relationship between the inability to delay&#xD;
      gratification and different patterns of mobile phone use. These studies highlight potential&#xD;
      power of mobile phenotyping as a ubiquitous measure of health determinants in billions of&#xD;
      people by using passive data that doesn't require user participation. However, foundational&#xD;
      research is needed to validate assessments, build adaptive tools, and include individual&#xD;
      differences self-regulation capacity as well as interventions to improve regulation in the&#xD;
      discussion.&#xD;
&#xD;
      The investigators propose to test a new diagnostic self-regulation mobile assessment tool&#xD;
      app. The application built in Apple's ResearchKit(™) and Android's ResearchStack(™) includes&#xD;
      a self-report assessment, three continuous performance tasks, and passive data collection&#xD;
      developed for in-person use.&#xD;
&#xD;
      The goal is that by differentiating between high and low impulsive people using mobile&#xD;
      assessment tools, the investigators identify those at greatest risk for self-regulation&#xD;
      problems. Individuals higher in impulsivity have less self-control when faced with short-term&#xD;
      temptations regardless of their knowledge of the consequences of these choices. This would be&#xD;
      the first step in developing a completely remote measurement tool for this purpose.&#xD;
&#xD;
      The primary goal of this exploratory project is to develop and validate a mobile application&#xD;
      to test impulsivity remotely, and test how self-report indicators of impulsivity via mobile&#xD;
      assessment correlate with objective impulsivity tests on the mobile phone.&#xD;
&#xD;
      Because this is an exploratory study, the investigators are looking at how often participants&#xD;
      use the mobile app in the real-world and how the tasks perform over time once they leave the&#xD;
      laboratory. In addition, the investigators will test the validity of the measures over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Impulsivity</measure>
    <time_frame>21 Days</time_frame>
    <description>Daily assessment of impulsivity.</description>
  </primary_outcome>
  <enrollment type="Actual">116</enrollment>
  <condition>Impulsive Behavior</condition>
  <condition>Self-Regulation</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Assessment only</intervention_name>
    <description>Mobile ecological assessment only.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participant must be fluent and able to read in English at the eight grade level, be between&#xD;
        the ages of 18 and 75, be willing to provide informed consent, and own a mobile smartphone&#xD;
        (iOS or Android) and are willing to receive and respond to text messages.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be fluent and able to read in English at the eighth grade level (self-report and&#xD;
             consent form quiz),&#xD;
&#xD;
          -  be between the ages of 18 and 75 (self-report, age in demographics),&#xD;
&#xD;
          -  be willing to provide informed consent, and&#xD;
&#xD;
          -  own a mobile smartphone (iOS or Android) and are willing to receive and respond to&#xD;
             text messages.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  are pregnant or breast feeding,&#xD;
&#xD;
          -  present with significant substance use which is defined as greater than once weekly&#xD;
             use in the past month (for any substance other than alcohol, nicotine or caffeine) or&#xD;
             greater than 21 standard alcoholic drinks per week for women and 24 for men,&#xD;
&#xD;
          -  present with a serious psychiatric illness or suicide risk as measured by previous&#xD;
             inpatient treatment, medications for psychosis or recent suicidality; a current&#xD;
             self-reported or clinician determined diagnosis of Major Depression or past or present&#xD;
             bipolar disorder, delusional disorder or schizophrenia, and/or&#xD;
&#xD;
          -  are unable to understand research study procedures as evidenced a score of less than 4&#xD;
             out of 5 on the consent form quiz.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederick Muench, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Addiction Services and Personalized Interventions Research (CASPIR)</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Billieux J, van der Linden M, Rochat L. The role of impulsivity in actual and problematic use of the mobile phone. Applied Cognitive Psychology 22: 1195-1210, 2008.</citation>
  </reference>
  <reference>
    <citation>Lazer D, Pentland A, Adamic L, Aral S, Barabasi AL, Brewer D, Christakis N, Contractor N, Fowler J, Gutmann M, Jebara T, King G, Macy M, Roy D, Van Alstyne M. Social science. Computational social science. Science. 2009 Feb 6;323(5915):721-3. doi: 10.1126/science.1167742. No abstract available.</citation>
    <PMID>19197046</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>January 22, 2018</last_update_submitted>
  <last_update_submitted_qc>January 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Impulsive Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will not be shared. No plan in place.</ipd_description>
  </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/NCT03006653
org study id: 16-693
nct id: NCT03006653
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Understanding Daily Fluctuations in Self-Regulation, also known as the Digital Marshmallow
      Test (DMT), is a collaboration by Northwell Health, Cornell Tech, and Sage Bionetworks.
      Funded by the Robert Wood Johnson Foundation, this is a pioneering study to advance the
      science in identifying and helping individuals who act on short-term temptations, despite
      long-term consequences. Using Apple's ResearchKit(™) and Android's ResearchStack
      applications, the Digital Marshmallow Test will leverage the powerful capabilities of the
      smartphone to examine impulsivity using a range of game-like tasks and sensor capabilities
      within the mobile phone. Across studies, more impulsive individuals are significantly more
      likely to suffer from obesity, Type II Diabetes, substance abuse, gambling problems, suicidal
      behaviors, and increased criminality among many other problems. Early self-report studies
      reveal a relationship between the inability to delay gratification and different patterns of
      mobile phone use. This will be the first study to develop non-invasive mobile methods to
      identify and help those at greatest risk for impulsive responding before serious problems
      occur.
Poor self-regulation and impulsivity are underlying symptoms of numerous mental health
      problems such as obesity, substance abuse, Attention Deficit Hyperactivity Disorder (ADHD),
      gambling, binge eating, bipolar disorder, borderline personality disorder, and suicidal
      behaviors. This makes it one of the most important personal and public health intervention
      targets. The classic Marshmallow Test done by Mischel and colleagues determined that the
      inability to delay gratification in childhood was predictive of lower Scholastic Aptitude
      Test (SAT) scores and higher BMI in adulthood. However, assessments of impulsivity and poor
      self-regulation are rarely included in routine medical care because of time and financial
      constraints.

      The mobile phone has changed our ability to assess and intervene with individuals remotely,
      providing an avenue for ambulatory diagnostic testing and just-in-time adaptive interventions
      that can be accessed by billions of people. Newer methods of assessment using the mobile
      phone, including Apple's ResearchKit, provide the opportunity for powerful assessments of
      impulsivity beyond simple self-report. To date, there have been no measures of impulsivity
      integrated into ResearchKit or any mobile application, aside from the beta version that the
      investigators recently built, nor has the research community explored the possibilities of
      passive impulsivity assessment using mobile analytics embedded in all phones. There is
      preliminary evidence that mobile analytics, such as latency to respond to a text, can predict
      personality traits associated with impulsivity such as extroversion and neuroticism, and
      self-report studies reveal that there is a direct relationship between the inability to delay
      gratification and different patterns of mobile phone use. These studies highlight potential
      power of mobile phenotyping as a ubiquitous measure of health determinants in billions of
      people by using passive data that doesn't require user participation. However, foundational
      research is needed to validate assessments, build adaptive tools, and include individual
      differences self-regulation capacity as well as interventions to improve regulation in the
      discussion.

      The investigators propose to test a new diagnostic self-regulation mobile assessment tool
      app. The application built in Apple's ResearchKit(™) and Android's ResearchStack(™) includes
      a self-report assessment, three continuous performance tasks, and passive data collection
      developed for in-person use.

      The goal is that by differentiating between high and low impulsive people using mobile
      assessment tools, the investigators identify those at greatest risk for self-regulation
      problems. Individuals higher in impulsivity have less self-control when faced with short-term
      temptations regardless of their knowledge of the consequences of these choices. This would be
      the first step in developing a completely remote measurement tool for this purpose.

      The primary goal of this exploratory project is to develop and validate a mobile application
      to test impulsivity remotely, and test how self-report indicators of impulsivity via mobile
      assessment correlate with objective impulsivity tests on the mobile phone.

      Because this is an exploratory study, the investigators are looking at how often participants
      use the mobile app in the real-world and how the tasks perform over time once they leave the
      laboratory. In addition, the investigators will test the validity of the measures over time.
observational model: Cohort
time perspective: Prospective
measure: Impulsivity
time frame: 21 Days
description: Daily assessment of impulsivity.
intervention type: Behavioral
intervention name: Assessment only
description: Mobile ecological assessment only.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frederick Muench, PhD
role: Principal Investigator
affiliation: Northwell Health
facility: 
country: United States
citation: Billieux J, van der Linden M, Rochat L. The role of impulsivity in actual and problematic use of the mobile phone. Applied Cognitive Psychology 22: 1195-1210, 2008.
citation: Lazer D, Pentland A, Adamic L, Aral S, Barabasi AL, Brewer D, Christakis N, Contractor N, Fowler J, Gutmann M, Jebara T, King G, Macy M, Roy D, Van Alstyne M. Social science. Computational social science. Science. 2009 Feb 6;323(5915):721-3. doi: 10.1126/science.1167742. No abstract available.
PMID: 19197046
responsible party type: Sponsor
mesh term: Impulsive Behavior
sharing ipd: No
ipd description: Data will not be shared. No plan in place.