Geolocation Positional System (GPS) Experience

Not Applicable

Recruiting

• Conditions: Emotions; Anhedonia; Depression
• Interventions: Behavioral: Modifying Exploration

• Registration Number: NCT05991713
• Lead Sponsor: University of Miami

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.

Study Timeline

• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Study Start: 2023-11-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2028-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modifying Exploration	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Coral Gables, Florida, United States