- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05991713
Geolocation Positional System (GPS) Experience
April 29, 2026 updated by: Aaron Heller, University of Miami
Individual Differences in Emotional and Behavioral Patterns and Their Relationship to Cognition
The purpose of this study is to use smartphone technology to capture individual location emotional and cognitive data, to examine how real-world behaviors thoughts, emotions, and brain activity are related to one another.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The observational portion of this study was initially approved in 2015, this is a subset of the initially approved study and it is a clinical trial of 100 participants.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Isabella C D'Ottone, BA
- Phone Number: 3052849555
- Email: icd30@miami.edu
Study Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33146
- Recruiting
- University of Miami
-
Principal Investigator:
- Aaron S Heller, PhD
-
Contact:
- Isabella C D'Ottone, BA
- Phone Number: 3052849555
- Email: icd30@miami.edu
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Must agree to give informed consent
- Must be willing to have an functional Magnetic Resonance Imaging (FMRI) scan
- Must be able to receive and respond to daily text messages assessing current emotion
- Must be willing to download and run a GPS tracking application (FollowMee) onto their smartphone for a four-month period
Exclusion Criteria:
- history of head trauma, seizures, or neurological disorders
- severe/unstable medical conditions
- conditions that interfere with MRI
- pregnancy
- lifetime psychotic/bipolar disorder
- chronic/severe substance or alcohol abuse/dependence
- antipsychotic medication
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
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Modifying Exploration
Individuals will be asked on certain days to increase their levels of exploration, and some days be asked to decrease their levels of exploration.
Participants will do this for up to six months.
|
Participants in this group will use a mobile phone sensor data application that uses an accelerometer, Wireless Fidelity (WiFi) and/or GPS designed for smartphone devices.
This technology allows the phones to capture information automatically and passively on the participant's activity.
The application will be collecting participants' data 24 hours a day, 7 days a week.
Participants will be asked to make alterations to their exploration levels approximately 20 days of their participation in the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in positive emotional response as measured by ecological momentary assessment
Time Frame: Baseline, up to 6 months
|
Emotional response will be measured by computing a total mean score of "happy", "excited", "content", "attentive", "relaxed".
The total mean score ranges from 0 to 100, with higher scores indicating greater positive emotional response.
|
Baseline, up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in negative emotional response as measured by ecological momentary assessment
Time Frame: Baseline, up to 6 months
|
Emotional response will be measured by computing a total mean score of "sad", "tired", "upset", "irritable", "anxious".
The total mean score ranges from 0 to 100, with higher scores indicating greater negative emotional response.
|
Baseline, up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Aaron S Heller, PhD, University of Miami
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)
November 2, 2023
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Study Registration Dates
First Submitted
August 7, 2023
First Submitted That Met QC Criteria
August 7, 2023
First Posted (Actual)
August 15, 2023
Study Record Updates
Last Update Posted (Actual)
May 5, 2026
Last Update Submitted That Met QC Criteria
April 29, 2026
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20150678
- R01MH133693 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
Fondation FondaMentalGYNOVNot yet recruitingDepression | Depression in Adults | Depression DisorderFrance
Clinical Trials on Modifying Exploration
-
NYU Langone HealthNational Institute on Deafness and Other Communication Disorders (NIDCD)Recruiting
-
Assistance Publique - Hôpitaux de ParisHopital Universitaire Robert-Debre; Henri Mondor University Hospital; Fondation... and other collaboratorsCompleted
-
University Hospital, Strasbourg, FranceRecruiting
-
Isfahan University of Medical SciencesCompletedPenetrating Injury in Upper LimbIran, Islamic Republic of
-
Ahmed Kamel Ali MohamedNot yet recruiting
-
Institute of Technology, SligoIrish Research CouncilSuspended
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingNasopharyngeal CarcinomaChina
-
Assistance Publique - Hôpitaux de ParisRecruitingChronic Obstructive Pulmonary Disease | SmokersFrance
-
Assiut UniversityNot yet recruitingSupracondylar Humerus Fracture | Vascular ComplicationsEgypt
-
University of LeicesterWellcome Trust; University Hospitals, Leicester; National Institute for Health...RecruitingCardiac Rehabilitation | South Asian Service UsersUnited Kingdom