EmotionsNCT05991713
Geolocation Positional System (GPS) Experience
A study testing Modifying Exploration in people with Emotions and Anhedonia, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotions, Anhedonia, Depression
- What is being tested?
- Modifying Exploration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2023to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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
Isabella C D'Ottone, BA, 3052849555, icd30@miami.edu
Aaron S Heller, PhD
About this study
Official title: Individual Differences in Emotional and Behavioral Patterns and Their Relationship to Cognition
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.
Read the 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.
- Conditions
- Emotions, Anhedonia, Depression
- Being tested
- Modifying Exploration
- Medical subject headings
- Anhedonia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modifying ExplorationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Modifying Exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, up to 6 months
Secondary outcomes (1)
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.
Measured: Baseline, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start2 Nov 2023
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmotionsStudies 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
- 100 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
- NCT05991713
- Sponsor's protocol ID
- 20150678
- Other IDs
- R01MH133693
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Differences in Emotional and Behavioral Patterns and Their Relationship to Cognition
- ClinicalTrials.gov ID
- NCT05991713
- Acronym / sponsor ID
- 20150678
- Conditions
- Emotions, Anhedonia, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modifying Exploration | Experimental | Behavioral: Modifying ExplorationIndividuals 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- history of head trauma, seizures, or neurological disorders
- severe/unstable medical conditions
- conditions that interfere with MRI
- pregnancy
- lifetime psychotic/bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modifying ExplorationParticipants 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. | Behavioural | Modifying Exploration |
Primary outcome
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.
1 secondary outcome
Change in negative emotional response as measured by ecological momentary assessment
Time frame: Baseline, up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron S Heller, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modifying Exploration in people with Emotions and Anhedonia, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabella C D'Ottone, BA (3052849555, icd30@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in positive emotional response as measured by ecological momentary assessment (time frame: Baseline, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.