Geolocation Positional System (GPS) Experience

Sponsor

University of Miami (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05991713

Collaborator

National Institute of Mental Health (NIMH) (NIH)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Emotions Anhedonia Depression	Behavioral: Modifying Exploration	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Individual Differences in Emotional and Behavioral Patterns and Their Relationship to Cognition

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2028

Anticipated Study Completion Date :

Jul 31, 2028

Arms and Interventions

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.	Behavioral: Modifying Exploration 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.

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.

Behavioral: Modifying Exploration

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.

Outcome Measures

Primary Outcome Measures

Change in positive emotional response as measured by ecological momentary assessment [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.

Secondary Outcome Measures

Change in negative emotional response as measured by ecological momentary assessment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Coral Gables	Florida	United States	33146

Sponsors and Collaborators

University of Miami
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Aaron S Heller, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aaron Heller, Associate Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT05991713

Other Study ID Numbers:

20150678
R01MH133693

First Posted:

Aug 15, 2023

Last Update Posted:

Aug 15, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anhedonia

Study Results

No Results Posted as of Aug 15, 2023