Back to resultsGeolocation Positional System (GPS) Experience
Primary Purpose
Emotions, Anhedonia, Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modifying Exploration
Sponsored by
About this trial
This is an interventional basic science trial for Emotions
Eligibility Criteria
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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Modifying Exploration
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in positive emotional response as measured by ecological momentary assessment
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.
Secondary Outcome Measures
Change in negative emotional response as measured by ecological momentary assessment
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.
Full Information
NCT ID
NCT05991713
First Posted
August 7, 2023
Last Updated
August 7, 2023
Sponsor
University of Miami
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05991713
Brief Title
Geolocation Positional System (GPS) Experience
Official Title
Individual Differences in Emotional and Behavioral Patterns and Their Relationship to Cognition
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2028 (Anticipated)
Study Completion Date
July 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotions, Anhedonia, Depression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Modifying Exploration
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Modifying Exploration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in positive emotional response as measured by ecological momentary assessment
Description
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.
Time Frame
Baseline, up to 6 months
Secondary Outcome Measure Information:
Title
Change in negative emotional response as measured by ecological momentary assessment
Description
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.
Time Frame
Baseline, up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire H Landon, BS
Phone
3052849555
Email
chl46@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron S Heller, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire H Landon, BS
Phone
305-284-9555
Email
chl46@miami.edu
First Name & Middle Initial & Last Name & Degree
Aaron S Heller, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Geolocation Positional System (GPS) Experience
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