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Clinical Trials/NCT05991713
NCT05991713RecruitingNot Applicable

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

University of Miami2 sites in 1 country100 target enrollmentStarted: November 2, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
2
Primary Endpoint
Change in positive emotional response as measured by ecological momentary assessment

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
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

Arms & Interventions

Modifying Exploration

Experimental

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: Modifying Exploration (Behavioral)

Outcomes

Primary Outcomes

Change in positive emotional response as measured by ecological momentary assessment

Time Frame: 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 Outcomes

  • Change in negative emotional response as measured by ecological momentary assessment(Baseline, up to 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aaron Heller

Associate Professor

University of Miami

Study Sites (2)

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