Major DepressionNCT07891624
Neural Mechanisms of Real-world Emotions and Internalizing
A study testing Academic Performance Feedback in people with Major Depression and Generalized Anxiety, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression, Generalized Anxiety, Emotions
- What is being tested?
- Academic Performance Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2026to 30 Nov 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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]
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Coral Gables, Florida, 33146
Aaron S Heller, PhD, 305-284-9498, axh825@miami.edu
Aaron Heller, PhD
About this study
Official title: Using High-stakes, Real-world Events to Map the Neural Dynamics Linked to Internalizing Disorders
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.
- Conditions
- Major Depression, Generalized Anxiety, Emotions
- Being tested
- Academic Performance Feedback
- Medical subject headings
- Depressive Disorder, Major, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Academic Performance FeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Academic Performance Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and end of academic semester (approximately 17 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start24 Aug 2026
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Aaron Heller, University of Miami
- Investigators
- Aaron S Heller, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891624
- Sponsor's protocol ID
- 20261271
- Other IDs
- R01MH142713
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.