Geolocation Positional System (GPS) Experience

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05991713
• Other study ID #: 20150678
• Secondary ID: R01MH133693
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: September 1, 2028

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: Isabella C D'Ottone, BA
• Phone: 3052849555
• Email: icd30[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2028
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anhedonia
• Depression
• Emotions

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, up to 6 months
Secondary	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.	Baseline, up to 6 months