Understanding Daily Fluctuations in Self-Regulation

January 22, 2018 updated by: Northwell Health
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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Great Neck, New York, United States, 11021
        • Center for Addiction Services and Personalized Interventions Research (CASPIR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impulsivity
Time Frame: 21 Days
Daily assessment of impulsivity.
21 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Frederick Muench, PhD, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

December 27, 2016

First Posted (Estimate)

December 30, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-693

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared. No plan in place.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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