Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT06705348

Conditions

Social Disconnection

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this research study is to examine the effect of social connectedness on the brain. Study procedures include one Magnetic Resonance Imaging (MRI) or functional Magnetic Resonance Imaging (fMRI) scan, one Positron Emission Tomography (PET) scan, one Magnetic Resonance Spectroscopy (MRS) scan, an electroencephalogram (EEG), and in-person and phone call follow-ups.

Conditions

Social Disconnection

Study ID

NCT06705348

Start date

May 8, 2023

Status verified date

Aug, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • able to give written informed consent
  • age 55+
  • English speaking

Exclusion Criteria:

  • contraindication to MRI scanning including claustrophobia, high girth, moderate to significant white matter atrophy, and presence of ferromagnetic material in the body, including orthodontic braces or other non MR-compatible foreign bodies. All participants will be screened for metal objects by the same methods used for routine clinical MRI scanning
  • for women: pregnancy or breastfeeding
  • serious medical or neurological illness that in the opinion of the PI would interfere with the scientific goals of the study or participant safety
  • pervasive developmental disorders (PDD) or primary psychotic disorders
  • meet DSM-5 criteria for current severe substance use disorder (except marijuana or nicotine)
  • head injury that led to significant long term decline in cognitive abilities as seen by decline in grades or work performance
  • current psychosis, active significant suicidal (score of 6 on MADRS suicide item) or homicidal ideation
  • lifetime history of neurologic abnormality including seizure disorder, cerebrovascular, or neoplastic lesion, neurodegenerative disorder, or significant head trauma resulting in post-traumatic amnesia >24 hours
  • full scale IQ lower than 70
  • contraindications to PET (e.g. poor venous access for placement of venous lines)
  • history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year
  • history of a bleeding disorder or currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto) \*for subjects obtaining arterial line.
  • blood donation within 8 weeks of the start of the study
  • REM sleep disorder
  • brain injury (TBI, seizure/epilepsy, stroke, TIA) in lifetime (self-report and medical chart review)
  • electroconvulsive or ketamine therapy, or similar therapies that have rapid effects on brain neurochemistry within the past 6 months
  • high risk for stroke (above first quartile on Framingham Stroke Risk Profile)
  • current cancer

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Transdiagnostic

Participants will be a transdiagnostic sample of older individuals (age 55+ years) with stress disorders without psychosis including individuals with MDD, bipolar disorder, post-traumatic stress disorder (PTSD), dysthymia, and non-psychiatric individuals.

Primary outcome measure

  • Social disconnection [ Time Frame: enrollment to end of study participation (approximately 1 year) ]
  • SV2A density [ Time Frame: enrollment to end of study participation (approximately 1 year) ]

Central Contacts and Locations

Central contacts

Sarah Boster, MA

203-737-7066Sarah.debonee@yale.edu

Nicole DellaGioia, MA

203-737-6884nicole.dellagioia@yale.edu

Locations

Yale Translational Brain Imaging Program

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Sarah Boster, MA

203-737-7066sarah.debonee@yale.edu

Nicole DellaGioia, MA

2037376884nicole.dellagioia@yale.edu

Principal Investigator:

Irina Esterlis, Ph.D.

More Information

Sponsor

Yale University

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • loneliness
  • social disconnection
  • isolation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-14.