NCT07891624

Brief Summary

This study utilizes mobile health methods, including smartphone technology, subjective self-reports measures of emotion, behavioral tasks, functional Magnetic Resonance Imaging (fMRI), physiological measures of attention and arousal, and measures of health and social support to identify neural mechanisms associated with individual differences in the temporal course of emotional responses. The aim of this project is to utilize real-world and personally relevant events as stimuli to better understand how the temporal course of emotional responses relate to risk for developing mental disorders.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
50mo left

Started Aug 2026

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 Progress4%
Aug 2026Nov 2030

Study Start

First participant enrolled

August 24, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2030

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

4.3 years

First QC Date

October 16, 2026

Last Update Submit

October 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean Duration of fMRI-Derived Negative Emotional Brain States

    Mean duration, measured in seconds, of fMRI-derived negative emotional brain states identified using hidden Markov modeling of default mode and salience network activity during academic performance feedback assessments.

    Baseline and end of academic semester (approximately 17 weeks)

Study Arms (1)

Participants Undergoing Academic Performance Feedback Assessments

EXPERIMENTAL

Participants undergo up to six study visits during one academic semester, including baseline and post-examination MRI assessments. During MRI sessions, participants anticipate and receive actual midterm examination grades while neural and physiological responses are measured. Participants also complete repeated mobile mood assessments and self-report measures throughout the semester.

Behavioral: Academic Performance Feedback

Interventions

Participants receive personally relevant academic performance feedback (actual midterm examination grades) during fMRI assessments. During each scan session, participants undergo a period of grade anticipation followed by disclosure of their exam grade while neural activity, physiological responses, and emotional experiences are assessed. The intervention is administered during repeated MRI sessions conducted over a single academic semester.

Participants Undergoing Academic Performance Feedback Assessments

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals who are between 18 - 35 years old. \[Reason: to be able to provide informed consent, and to minimize variation in functional and structural differences in brain\]
  • Individuals who are fluent English speakers. \[Reason: to understand study instructions \& questionnaires\]
  • Smart phone access. \[Reason: to answer the questionnaires that are administered throughout the study.

You may not qualify if:

  • Women who are pregnant or breast feeding and are no more than six months post-partum. \[Reason: may be unsafe for fetus, may affect outcome measure(s)\]
  • Individuals who are excluded based on attached metal resonance Screening Form (Note: this form has already been approved by the Institutional Review Board (IRB for other protocols). \[Reason: necessary to participate in MRI research protocol\]
  • Individuals whose BMI is above 35. \[Reason: must fit into fMRI scanner\]
  • Individuals who have claustrophobia. \[Reason: to be able to stay in MRI scanner\]
  • Individuals who are unable, in the judgment of the investigator, to comply with directions and/or tolerate the procedures required for participation in this trial. \[Reason: to be able to understand instructions and ensure safety\]
  • Individuals who are unable to safely undergo MRI scanning. \[Reason: to be able to undergo MRI scanning\]

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

Depressive Disorder, MajorGeneralized Anxiety Disorder

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersAnxiety Disorders

Study Officials

  • Aaron S Heller, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron S Heller, PhD

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
Professor of Psychology

Study Record Dates

First Submitted

October 16, 2026

First Posted

October 23, 2026

Study Start

August 24, 2026

Primary Completion (Estimated)

November 30, 2030

Study Completion (Estimated)

November 30, 2030

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will share

The proposed research will generate data including self-report, structured interviews, and FMRI measures from young adults. Data will be publicly shared via datalad.org within 1 year after data collection is completed. Data will be linked to one another and connected to code via github. This approach is the currently recommended approach by the Center for Reproducible Neuroscience at Stanford. Code will be uploaded to the lab's github page.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
1 year after study is completed

Locations