LonelinessNCT04577911
How is Social Connection Represented in the Brain?
An observational study of Loneliness, run by Columbia University at 1 site in United States.
Trial summary
Nearly half of the U.S. population sometimes or always experiences loneliness, which is alarming given that loneliness confers risk for negative mental and physical health outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- Basic Science Experiment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to Nov 2026
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be between the ages of 18 and 65
Who may be able to join
- safe for MRI scanning
- not taking psychiatric medication
Who cannot join
- not safe for MRI scanning
- taking psychiatric 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
Columbia University Irving Medical Center
New York, New York, 10032
Meghan L Meyer, PhD, 650-521-1701
About this study
Official title: Using the Brain to Reveal Mental Representations of Subjective Connection
Nearly half of the U.S. population sometimes or always experiences loneliness, which is alarming given that loneliness confers risk for negative mental and physical health outcomes. Extensive research suggests loneliness is characterized by subjective isolation: many lonely individuals maintain a number of relationships but still report feeling lonely. The goal of this proposal is to use functional magnetic resonance imaging to reveal how the brain represents our subjective connection to and isolation from other people, which will ultimately inform optimal ways to intervene to reduce loneliness.
Read the detailed description
Extensive research suggests loneliness is characterized by subjective isolation: many lonely individuals maintain a number of relationships but still report feeling lonely. Thus, a neurobiological account of loneliness requires that we understand how the brain represents subjective connections to others and how loneliness alters these representations. The long-term goal of this proposal is to identify how subjective isolation is represented in the brain in order to identify novel ways to intervene on this representation to attenuate loneliness. This study proposes that the brain organizes representations of people based on subjective connection to them, and that loneliness systematically alters this organization. The Specific Aim 1 will determine whether subjective closeness organizes self and other representations in the brain. While undergoing fMRI, participants will complete tasks in which they reflect on themselves and other people. They will also report on their subjective closeness to the other people. The study will test whether the brain organizes mental representations of the self and one's own social network members based on subjective closeness. The Specific Aim 2 will determine how loneliness modulates self and other representations in the brain. The Specific, Exploratory Aim 3 will determine the cognitive consequences of altered self and other representation in loneliness. The proposal of this study is imperative for ultimately revealing neurocognitive mechanisms to intervene on to reduce loneliness.
- Conditions
- Loneliness
- Being tested
- Basic Science Experiment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Science ExperimentOther
participants complete cognitive tasks while undergoing functional magnetic resonance imaging (fMRI)
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygenated-Level Dependent (BOLD) Response
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Apr 2021
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Meghan Meyer, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577911
- Sponsor's protocol ID
- AAAU7311
- Other IDs
- 1R01MH125406-01
- Status last verified
- Dec 2025
- First submitted
- 30 Sep 2020
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Brain to Reveal Mental Representations of Subjective Connection
- ClinicalTrials.gov ID
- NCT04577911
- Acronym / sponsor ID
- AAAU7311
- Conditions
- Loneliness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Oct 2020 (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.
Nearly half of the U.S. population sometimes or always experiences loneliness, which is alarming given that loneliness confers risk for negative mental and physical health outcomes. Extensive research suggests loneliness is characterized by subjective isolation: many lonely individuals maintain a number of relationships but still report feeling lonely. The goal of this proposal is to use functional magnetic resonance imaging to reveal how the brain represents our subjective connection to and isolation from other people, which will ultimately inform optimal ways to intervene to reduce loneliness.
Detailed description
Extensive research suggests loneliness is characterized by subjective isolation: many lonely individuals maintain a number of relationships but still report feeling lonely. Thus, a neurobiological account of loneliness requires that we understand how the brain represents subjective connections to others and how loneliness alters these representations. The long-term goal of this proposal is to identify how subjective isolation is represented in the brain in order to identify novel ways to intervene on this representation to attenuate loneliness. This study proposes that the brain organizes representations of people based on subjective connection to them, and that loneliness systematically alters this organization. The Specific Aim 1 will determine whether subjective closeness organizes self and other representations in the brain. While undergoing fMRI, participants will complete tasks in which they reflect on themselves and other people. They will also report on their subjective closeness to the other people. The study will test whether the brain organizes mental representations of the self and one's own social network members based on subjective closeness. The Specific Aim 2 will determine how loneliness modulates self and other representations in the brain. The Specific, Exploratory Aim 3 will determine the cognitive consequences of altered self and other representation in loneliness. The proposal of this study is imperative for ultimately revealing neurocognitive mechanisms to intervene on to reduce loneliness.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be between the ages of 18 and 65
Key inclusion criteria (2 listed)
- safe for MRI scanning
- not taking psychiatric medication
Key exclusion criteria (2 listed)
- not safe for MRI scanning
- taking psychiatric medication
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 |
|---|---|---|
| Basic Science Experimentparticipants complete cognitive tasks while undergoing functional magnetic resonance imaging (fMRI) | Other | – |
Primary outcome
Blood Oxygenated-Level Dependent (BOLD) Response
Time frame: 2 hours
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 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Meghan Meyer, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Loneliness, run by Columbia University 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 2 inclusion and 2 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 16 Dec 2025. 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 Meghan L Meyer, PhD (650-521-1701, mlm2378@columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Oxygenated-Level Dependent (BOLD) Response (time frame: 2 hours). 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 16 Dec 2025.