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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05991713
Other study ID # 20150678
Secondary ID R01MH133693
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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