Social Disconnection Study

NCT06705348 | Recruiting

• 1 other identifier: 2000033973
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

loneliness; social disconnection; isolation

Outcome Measures

Primary Outcomes (2)

• Social disconnection

  Social disconnection composite measure determined by the following: Item #3 - Hamilton Depression Rating Scale (social withdrawal; range = 0-4) Item #12 - Beck Depression Inventory-II (loss of interest in people; range = 0-3) Item #14 - Center for Epidemiologic Studies Depression Scale (feelings of loneliness; range = 0-3) Item #2 - Snaith-Hamilton Pleasure Scale (enjoyment being with family or close friends; range = 0-1) Item #7 - Snaith-Hamilton Pleasure Scale (enjoyment seeing other people's smiling faces; range = 0-1) Item #17 - Profile of Mood States (loneliness; range = 0-4) Higher composite score = greater severity of social disconnection.

  enrollment to end of study participation (approximately 1 year)

• SV2A density

  SV2A density as measured using \[18F\]SDM8 PET imaging.

  enrollment to end of study participation (approximately 1 year)

Secondary Outcomes (3)

• Composite measure of suicide risk

  enrollment to end of study participation (approximately 1 year)

• Sex

  enrollment to end of study participation (approximately 1 year)

• Composite measure of suicide risk over time

  12-month study period (from scanning to year 1 follow-up)

Study Arms (1)

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.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Translational Brain Imaging Program

New Haven, Connecticut, 06510, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood may be collected for genetic testing of APOE (a gene associated with Alzheimer's disease) and for DNA testing of polymorphisms in genes of interest to mental health.

Study Officials

• Irina Esterlis, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Boster, MA

CONTACT

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

Nicole DellaGioia, MA

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 26, 2024
• Study Start: May 8, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

US (1)