Impulsive BehaviorNCT03006653
Understanding Daily Fluctuations in Self-Regulation
An observational study of Impulsive Behavior and Self-Regulation, run by Northwell Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Impulsive Behavior, Self-Regulation
- What is being tested?
- Assessment only
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participant must be fluent and able to read in English at the eight grade level, be between the ages of 18 and 75, be willing to provide informed consent, and own a mobile smartphone (iOS or Android) and are willing to receive and respond to text messages.
Who may be able to join
- be fluent and able to read in English at the eighth grade level (self-report and consent form quiz),
- be between the ages of 18 and 75 (self-report, age in demographics),
- be willing to provide informed consent, and
- own a mobile smartphone (iOS or Android) and are willing to receive and respond to text messages.
Who cannot join
- are pregnant or breast feeding,
- present with significant substance use which is defined as greater than once weekly use in the past month (for any substance other than alcohol, nicotine or caffeine) or greater than 21 standard alcoholic drinks per week for women and 24 for men,
- present with a serious psychiatric illness or suicide risk as measured by previous inpatient treatment, medications for psychosis or recent suicidality; a current self-reported or clinician determined diagnosis of Major Depression or past or present bipolar disorder, delusional disorder or schizophrenia, and/or
- are unable to understand research study procedures as evidenced a score of less than 4 out of 5 on the consent form quiz.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Addiction Services and Personalized Interventions Research (CASPIR)
Great Neck, New York, 11021
About this study
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.
Read the detailed description
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.
- Conditions
- Impulsive Behavior, Self-Regulation
- Being tested
- Assessment only
- Medical subject headings
- Impulsive Behavior, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment onlyBehavioural
Mobile ecological assessment only.
What is being measured
The primary outcome is the main question the study is designed to answer.
Impulsivity
Daily assessment of impulsivity.
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start1 Jan 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Impulsive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, Sage Bionetworks
- Responsible party
- Sponsor
- Investigators
- Frederick Muench, PhD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006653
- Sponsor's protocol ID
- 16-693
- Status last verified
- Jan 2018
- First submitted
- 27 Dec 2016
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will not be shared. No plan in place.
Publications
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.
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.
PubMed 19197046Wen H, Sobolev M, Vitale R, Kizer J, Pollak JP, Muench F, Estrin D. mPulse Mobile Sensing Model for Passive Detection of Impulsive Behavior: Exploratory Prediction Study. JMIR Ment Health. 2021 Jan 27;8(1):e25019. doi: 10.2196/25019.
PubMed 33502330Sobolev M, Vitale R, Wen H, Kizer J, Leeman R, Pollak JP, Baumel A, Vadhan NP, Estrin D, Muench F. The Digital Marshmallow Test (DMT) Diagnostic and Monitoring Mobile Health App for Impulsive Behavior: Development and Validation Study. JMIR Mhealth Uhealth. 2021 Jan 22;9(1):e25018. doi: 10.2196/25018.
PubMed 33480854
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Daily Fluctuations in Self-Regulation
- ClinicalTrials.gov ID
- NCT03006653
- Acronym / sponsor ID
- 16-693
- Conditions
- Impulsive Behavior, Self-Regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Cornell University, Sage Bionetworks
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participant must be fluent and able to read in English at the eight grade level, be between the ages of 18 and 75, be willing to provide informed consent, and own a mobile smartphone (iOS or Android) and are willing to receive and respond to text messages.
Key inclusion criteria (4 listed)
- be fluent and able to read in English at the eighth grade level (self-report and consent form quiz),
- be between the ages of 18 and 75 (self-report, age in demographics),
- be willing to provide informed consent, and
- own a mobile smartphone (iOS or Android) and are willing to receive and respond to text messages.
Key exclusion criteria (4 listed)
- are pregnant or breast feeding,
- present with significant substance use which is defined as greater than once weekly use in the past month (for any substance other than alcohol, nicotine or caffeine) or greater than 21 standard alcoholic drinks per week for women and 24 for men,
- present with a serious psychiatric illness or suicide risk as measured by previous inpatient treatment, medications for psychosis or recent suicidality; a current self-reported or clinician determined diagnosis of Major Depression or past or present bipolar disorder, delusional disorder or schizophrenia, and/or
- are unable to understand research study procedures as evidenced a score of less than 4 out of 5 on the consent form quiz.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment onlyMobile ecological assessment only. | Behavioural | – |
Primary outcome
Impulsivity
Time frame: 21 Days
Daily assessment of impulsivity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- BackgroundBillieux 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.
- Background: PubMed 19197046Lazer 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.
- Derived from this study: PubMed 33502330Wen H, Sobolev M, Vitale R, Kizer J, Pollak JP, Muench F, Estrin D. mPulse Mobile Sensing Model for Passive Detection of Impulsive Behavior: Exploratory Prediction Study. JMIR Ment Health. 2021 Jan 27;8(1):e25019. doi: 10.2196/25019.
- Derived from this study: PubMed 33480854Sobolev M, Vitale R, Wen H, Kizer J, Leeman R, Pollak JP, Baumel A, Vadhan NP, Estrin D, Muench F. The Digital Marshmallow Test (DMT) Diagnostic and Monitoring Mobile Health App for Impulsive Behavior: Development and Validation Study. JMIR Mhealth Uhealth. 2021 Jan 22;9(1):e25018. doi: 10.2196/25018.
- Individual participant dataSharing planned: No. Data will not be shared. No plan in place.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Muench, PhD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impulsive Behavior and Self-Regulation, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impulsivity (time frame: 21 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03006653, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.