NCT05991713

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Nov 2023Sep 2028

First Submitted

Initial submission to the registry

August 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 2, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

May 5, 2026

Status Verified

August 1, 2025

Enrollment Period

4.8 years

First QC Date

August 7, 2023

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in negative emotional response as measured by ecological momentary assessment

    Baseline, up to 6 months

Study Arms (1)

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.

Behavioral: Modifying Exploration

Interventions

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.

Modifying Exploration

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

RECRUITING

MeSH Terms

Conditions

AnhedoniaDepression

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Aaron S Heller, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabella C D'Ottone, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 15, 2023

Study Start

November 2, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

May 5, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations